A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
September 24, 2015
- CDC Urges Nursing Homes to Step Up ‘Superbug’ Prevention
- Influenza Vaccination Coverage among Health Care Personnel — United States, 2014–15 Influenza Season
- Most Americans Will Get a Wrong or Late Diagnosis at Least Once in Their Lives
- New Catalyst Yields More Accurate Prostate Cancer Test
- Tighter Blood Glucose Goals for Diabetes
- Molecular Tests Linked to C difficile Overdiagnosis
- Alzheimer’s Disease is Really Three Distinct Subtypes, UCLA Study Says
- Elevated Uric Acid Correlates with High Risk of Acute Kidney Injury
- Bladder Cancer Death Risk Higher in Patients with Blood Type A
- FDA Advisers Urge Approval of New Flu Vaccine for Seniors
- Vaccine Offers New Hope for Removing Precancerous Cervical Lesions
- New Group of Antibiotics Kills Drug-Resistant Staph Infection
- Undiagnosed Diseases Network Launches Online Application Portal
- Measuring and Improving Patient Safety through Health Information Technology: The Health IT Safety Framework
- ONC Issues Guidance for Consumer-Centric Telehealth Visits
View Previous Issues - Healthcare News Archive
CDC Urges Nursing Homes to Step Up ‘Superbug’ Prevention
Federal health officials are urging nursing homes to step up their oversight of antibiotic use to prevent outbreaks of “superbugs” that are on the rise nationally. The Centers for Disease Control and Prevention (CDC) issued new recommendations aiming to crack down on the improper use of the medications, which can spur antibiotic-resistance illnesses known as “superbugs.” "Superbugs that are hard to treat pose a health risk to all Americans, particularly the elderly whose bodies don’t fight infection as well,” CDC Director Tom Frieden wrote in a release announcing the new guidelines. The CDC says it is specifically focusing on nursing homes because of the prevalence of antibiotics there: About 70 percent of the 4 million people living in nursing homes received at least one antibiotic prescription each year. Between one-third to one-half of antibiotic prescriptions were unnecessary or inappropriate, according to a recent study that has raised alarms within the CDC.
Influenza Vaccination Coverage among Health Care Personnel — United States, 2014–15 Influenza Season
Health care personnel (HCP) should be vaccinated for flu every flu season to protect themselves, their patients, and their families from seasonal flu. Comprehensive, work-site intervention strategies that include education, promotion, and easy access to vaccination at no cost for multiple days can increase HCP vaccination coverage. The Advisory Committee on Immunization Practices (ACIP) recommends that all health-care personnel (HCP) be vaccinated annually against influenza. Vaccination of HCP can reduce influenza-related morbidity and mortality among HCP and their patients. Overall, 77.3 percent of HCP reported receiving an influenza vaccination in the 2014-15 season, similar to the 75.2 percent coverage among HCP reported in the 2013-14 season. Coverage was highest among HCP working in hospitals (90.4 percent) and lowest among HCP working in long-term care (LTC) settings (63.9 percent). Vaccination coverage was 96 percent among HCP with an employer requirement for vaccination. Among HCP without an employer requirement for vaccination, vaccination coverage was higher for HCP working in settings where vaccination was offered on-site at no cost for one day (73.6 percent) or multiple days (83.9 percent) compared with HCP working in settings where vaccination was promoted but not offered on-site (59.5 percent) or not promoted in any manner (44.0 percent).
Most Americans Will Get a Wrong or Late Diagnosis at Least Once in Their Lives
Most Americans who go to the doctor will get a diagnosis that is wrong or late at least once in their lives, sometimes with terrible consequences, according to a report released by an independent panel of medical experts. This critical type of health-care error is far more common than medication mistakes or surgery on the wrong patient or body part. But until now, diagnostic errors have been a relatively understudied and unmeasured area of patient safety. Much of patient safety is focused on errors in hospitals, not mistakes in diagnoses that take place in doctors’ offices, surgical centers and other outpatient facilities. The new report by the Institute of Medicine, the health arm of the National Academy of Sciences, outlines a system-wide problem. The report's authors say they don't know how many diagnostic errors take place. But the report cited one estimate that such errors affect at least 12 million adults each year, or about 5 percent of adults who seek outpatient care.
CAP Releases Legislative Proposal for Oversight of Laboratory-Developed Tests
At a time when Congress is considering several approaches to the oversight of laboratory-developed tests (LDTs), the College of American Pathologists (CAP) is releasing its legislative proposal for LDTs to meet the needs of patients and strike the right balance to LDT oversight through a public-private approach. The legislative proposal is based upon the CAP's original LDT framework first presented to the Food and Drug Administration (FDA) and other stakeholders in 2009. New components of the CAP’s legislative proposal include:
- Exemptions for LDTs used to respond to public health and infectious disease emergencies. This ensures the continued use of LDTs in the event of a local, regional, or national public health or emergency threat by temporarily suspending regulatory requirements.
- Identifying low-volume and public health testing as low-risk tests under the CAP’s regulatory approach.
- A public and transparent process for classification of LDTs into risk categories, and for reclassification of LDTs from one risk category to another when necessary.
Laboratory Testing / Diagnostics
New Catalyst Yields More Accurate Prostate Cancer Test
Say you’ve been diagnosed with prostate cancer, the second-leading cause of cancer death in men. You opt for surgery to remove your prostate. Three months later, a prostate surface antigen (PSA) test shows no prostate cells in your body. Everyone rejoices. Until 18 months later, when another PSA test reveals that now prostate cells have reappeared. What happened? The first PSA test yielded what’s known as a false negative result. It did not detect the handful of cells that remained after surgery and later multiplied. Now a chemist at Michigan Technological University has made a discovery that could, among other things, slash the numbers of false negatives in PSA tests. Xiaohu Xia and his team, including researchers from Louisiana State University and the University of Texas at Dallas, have developed a new catalyst that could make lab tests like the PSA much more sensitive. And it may even speed up reactions that neutralize toxic industrial chemicals before they enter lakes and streams. Their new catalyst, made from nanoscale cubes of palladium coated with a few layers of iridium atoms, does just that. PSA tests Xia’s team conducted using the palladium-iridium catalyst were 110 times more sensitive than tests completed with the conventional peroxidase.
Tighter Blood Glucose Goals for Diabetes
British NICE recommends 6.5% HbA1c target for adults and children.
New guidelines issued by the British National Institute for Health and Care Excellence (NICE) on diagnosing and managing type 1 diabetes are calling for tighter blood glucose targets in adults. Previous guidance had suggested a target HbA1C level of less than 7.5% to prevent microvascular disease and 6.5% or lower for individuals at high risk of developing peripheral arterial disease. The newly revised guidance recommends a target level of 6.5% or lower (48 mmol/mol) to prevent these types of complications. NICE recommends measuring HbA1c levels in type 1 diabetes patients every 3 to 6 months. Measurements should take place more often if an individual experiences rapid changes in his or her blood glucose control. Methods calibrated by the International Federation of Clinical Chemistry and Laboratory Medicine should be used to measure HbA1c, NICE advises.
Molecular Tests Linked to C. difficile Overdiagnosis
Patients who test positive on polymerase chain reaction (PCR) tests for Clostridium difficile DNA may not be infected, and therefore not need treatment for C difficile infection (CDI), according to the results of a prospective observational study published online September 8 in JAMA Internal Medicine. "Exclusive reliance on molecular tests for CDI diagnosis without tests for toxins or host response is likely to result in overdiagnosis, overtreatment, and increased health care costs," study author Christopher R. Polage, MD, from the Department of Pathology and Laboratory Medicine, University of California, Davis, School of Medicine, Sacramento, and colleagues write. Polymerase chain reaction tests have been adopted by 44% of acute care hospitals since 2009, sometimes replacing the immunoassay test for C difficile toxins. This change has been accompanied by a 50% to 100% surge in reported rates of CDI, the authors note.
U Victoria-Genome BC Team Develops 97-Protein MRM Panel for Dried Blood Spot Analysis
Researchers at the University of Victoria-Genome British Columbia Proteomics Centre have developed a multiple-reaction monitoring mass spec assay for simultaneously quantifying 97 proteins in dried blood spots. The protein panel, which was detailed in a paper published this month in Molecular & Cellular Proteomics, is one of the largest to date to use dried blood spots as a sample source. To date, the bulk of dried blood spot work has focused on small molecule research, such as pharmacokinetic assays. However, interest is growing among proteomics and protein biomarker researchers, as well, driven by the convenience and potential savings the sample format offers. In addition to patient convenience, dried blood spots also promise to be a much more economical sample format than conventional blood draws. The latter, Borchers said, require a cold chain infrastructure that includes rapid shipping on dry ice via services like FedEx.
New Biosensing Film Can Diagnose both Viral and Bacterial Infections Cheaply and without the Need for Traditional Clinical Pathology Laboratory Tests
New technology could shift the paradigm in infectious disease testing by clinical laboratories, while also giving hospitals a faster way to identify hospital-acquired infections (HAIs) and monitor patients for infections post-discharge. The diagnostic technology is built into a special “biosensing film” made of cellulose paper and a flexible polymer. Researchers at Florida Atlantic University (FAU) developed the biosensing film. They say it can detect and discern HIV, Staphylococcus aureus, E. coli and other bacteria in blood, plasma, and saliva. The test is inexpensive, disposable, and portable. Best of all (at least for developing countries, remote locations, and places that have few resources), it requires no expensive infrastructure or a clinical laboratory.
Launching Saliva Detection Test for Oral Cancer, PeriRx Sees Opportunity for Early-Stage Disease Dx
PeriRx, a Pennsylvania-based developer of non-invasive oral diagnostic technology, has launched SaliMark OSCC, which it said is the first commercial saliva test for the early detection of oral squamous cell carcinoma. The test kit contains biomarkers identified in an initial study done by the Early Detection Research Network (EDRN), an initiative of the National Cancer Institute. The biomarkers and the test were pre-validated by David Wong, a professor in the University of California at Los Angeles' School of Dentistry. A prospective blind study using the kit as a testing method was also performed by researchers at PeriRx the results of which were published in the May 2015 volume of theCompendium of Continuing Education in Dentistry.
Pitt/UPCI Next-Gen Sequencing Test Identifies Cancerous Thyroid Nodules with High Degree of Accuracy
A next-generation sequencing test is successfully predicting which thyroid nodules are cancerous and require surgical removal, reducing the need for multiple invasive diagnostic procedures, according to researchers at the University of Pittsburgh Cancer Institute (UPCI) and Pitt School of Medicine. Their findings were recently published online in the journal Thyroid. In up to 80 percent of cases, examination of cells collected with a fine needle from a suspicious lump in the thyroid, a gland in the front of the neck, typically can tell a pathologist whether it is benign or malignant, said lead investigator Yuri Nikiforov, M.D., Ph.D., professor of pathology and director of Pitt's Division of Molecular and Genomic Pathology. "However, in 20 percent of cases, the result is indeterminate, meaning we can't say for certain whether the nodule is cancerous," he said. University of Pittsburgh School of Medicine
Johns Hopkins Researchers Develop Hand-Held Chlamydia Test
Researchers at the Johns Hopkins University have developed a low-cost diagnostic tool, slightly larger than a coffee mug that detects chlamydia within 30 minutes. Scientists hope the apparatus, unofficially called mobiLab, will improve screening for the common and often symptomless sexually transmitted disease that, if left untreated, can cause permanent damage to a woman's reproductive system and lead to fatal ectopic pregnancies. The prototype, developed by researchers in the Hopkins Department of Biomedical Engineering, is made of a disposable cartridge for a genital swab sample and a heating unit that incubates the DNA to facilitate a reaction. The test results are delivered to and processed by a mobile app on a smartphone connected to the battery-powered device.
New Blood Test May Help Predict Heart Disease Risks in Obese Black Teens
A new blood test appears to help predict the risk for future heart disease among black teens struggling with obesity. The test was designed to measure changes in the T-cell status of obese teens. T-cells are a key component of the immune system, and increased T-cell activation reflects the kind of systemic inflammation that is often triggered by obesity, the researchers explained. Inflammation has been linked to heart disease, they added. A blood test trial involving both white and black teens revealed that obese black girls seem to be particularly prone to such increases in T-cell activity. Obese white boys and girls did not display a similar inflammatory response. The finding, along with the blood test itself, raises the prospect that clinicians may be better able to spot signs of impending heart disease long before it strikes. Source:http://consumer.healthday.com/kids-health-information-23/adolescents-and-teen-health-news-719/new-blood-test-may-predict-heart-disease-risks-in-obese-black-teens-703178.html
Study Suggests Existing RT-PCR Assays Can Detect Ebola Virus in Semen
A study by investigators from the National Institute of Allergy and Infectious Diseases suggests that existing RT-PCR assays can pick up the presence of Ebola virus in semen samples from survivors who are otherwise deemed disease-free. In the Journal of Infectious Diseases the researchers reported how they spiked half a dozen semen samples and half a dozen whole-blood samples with serial dilutions of EBOV. They then looked at whether the virus could be detected using RT-PCR-based assays that are already being using with Emergency Use Authorization for finding EBOV in whole-blood or plasma samples. Indeed, the team found EBOV RNA in the semen samples using the TaqMan EZ-1 real-time RT-PCR assay — originally designed to detect the Ebola Zaire virus — and the Minor Groove Binding (MGB) quantitative RT-PCR assay, suggesting such tests may be useful for identifying individuals who may be at risk of unwittingly passing on the virus.
Research and Development
Alzheimer’s Disease is Really Three Distinct Subtypes, UCLA Study Says
The discovery could fundamentally change the way that the disease is understood, treated – and eventually cured, said the University of California at Los Angeles scientist behind it. “Because the presentation varies from person to person, there has been suspicion for years that Alzheimer’s represents more than one illness,” said Dale Bredesen, a professor of neurology at the school who authored the study, which appears this week in the journal Aging.
The three types vary widely – and present a biochemical way of looking at the disease, the scientists said. The inflammatory variety of the disease shows markers such as C-reactive protein, and serum albumin to globulin ratios, are increased. The non-inflammatory kind doesn’t show those kind of biomarkers increasing – but is indicated by other metabolic abnormalities, they found. The third subtype is the cortical, which is seen in relatively young people – and spreads more widely across the brain than the other kind. The cortical kind is different in that it is often misdiagnosed, and language skills are lost at first, with only memory loss coming later. This variety also affects people who do not have an Alzheimer’s gene – and is connected to a significant zinc deficiency, they added.
Novel CSF Biomarker Tracks Nerve Dysfunction in Alzheimer's
—May have both predictive and diagnostic value
Neurogranin has potential as a novel cerebrospinal fluid (CSF) biomarker for synaptic dysfunction in Alzheimer disease (AD), a longitudinal study has confirmed. What's more, levels of neurogranin in CSF appear to have a prognostic, as well as a diagnostic value, Maartje I. Kester, MD, PhD of VU University Medical Center in Amsterdam, and colleagues reported online in JAMA Neurology. The study showed that neurogranin elevation, seen in patients with Alzheimer disease (AD) but not in cognitively normal controls, predicted progression from mild cognitive impairment (MCI) to AD, said the investigators. "In addition to the 'core CSF biomarkers' beta amyloid-42, total tau, and P-tau, the neurogranin level could have added value because it is a reflection of a pathophysiological process that is directly related to cognitive changes such as synapse function" Kester told MedPage Today.
Elevated Uric Acid Correlates with High Risk of Acute Kidney Injury
According to the findings of our study, we demonstrate that the admission serum uric acid level is correlated with the incidence of acute kidney injury and the need for renal replacement therapy during hospitalization. Also, there is a positive correlation between admission serum uric acid level and the risk of developing acute kidney injury (AKI), with the highest risk in the admission serum uric acid >9.4 mg/dL patient group. The lowest risk group was admission serum uric acid <3.4 mg/dL. After adjusting for potential confounders, we found that serum uric acid >9.4 mg/dL was associated with a higher risk of developing AKI, with odds ratio (OR) of 1.79 [95% CI 1.13–2.82] using the most common serum uric acid level range (5.8–7.6 mg/dL) as the reference group. On the other hand, admission serum uric acid <3.4 and 3.4–4.5 mg/dL were associated with a lower AKI risk, with ORs of 0.38 (95% CI 0.17–0.75) and 0.50 (95% CI 0.28–0.87), respectively.
Our study found a positive linear correlation between admission serum uric acid level and the risk of developing AKI in hospitalized patients. Also, the findings of our study show a prognostic effect of admission serum uric acid level on the acute kidney injury development. These findings may help improve clinicians’ ability to identify patients at high risk for AKI, ultimately to improve the quality of care and outcomes.
Bladder Cancer Death Risk Higher in Patients with Blood Type A
Patients who undergo radical cystectomy (RC) for bladder cancer are at increased risk of dying from the malignancy if they have blood type A rather than O, a study found. In a retrospective study of 2,086 patients with urothelial carcinoma (UC) of the bladder treated with RC, a team at Mayo Clinic in Rochester, Minn., led by Boris Gershman, MD, found that non-O blood type was associated with significantly worse 5-year recurrence-free survival and cancer-specific survival compared with O blood type (65% vs. 69% and 64% vs. 70%, respectively). On multivariate analysis, blood type A was independently associated with a significant 22% increased risk of death from bladder cancer compared with blood type O, the researchers reported online ahead of print in Urologic Oncology.
Hope for Faster Treatment of Urinary Tract Infections
Urinary tract infections can be treated more quickly using a new DNA sequencing device, according to research. Scientists from the University of East Anglia (UEA) say the device - the size of a USB stick - can detect bacteria directly from urine samples four times more quickly than traditional methods. The technology could lead to faster treatment and better use of antibiotics, they say. The findings were unveiled at a medical conference in San Diego. Prof David Livermore, from UEA's Norwich Medical School, said there was a need to move beyond the current "carpet-bombing" approach to treating urinary tract infections (UTIs).
Smells Like Tuberculosis?
—Sensor study suggests breath samples might reveal disease
"Smell technology" might improve the diagnosis of pulmonary and extrapulmonary tuberculosis (TB) around the world, a researcher said here. A device that detects a pattern of chemicals in the breath was both sensitive and specific for TB in a small pilot study, according to Amandip Sahota, MD, of the University Hospitals of Leicester in England. In the study, the device was able to detect both pulmonary and extrapulmonary forms of the disease, Sahota reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The idea of using breath samples to detect disease is not new, Sahota noted, but his study employed a technology -- Field Asymmetric Ion Mobility Spectrometry (FAIMS) -- -- that has the potential to be cheaper, faster, and more widely available than earlier methods. But he cautioned that the study, involving just 25 patients and 19 healthy controls, needs to be validated in a larger cohort.
Scientists Uncover Bacterial Mechanism That Links Gum Disease to Heart Disease
A new study clarifies the microbiology underlying the well-established link between gum disease and heart disease by identifying the effect of a bacterium common to both conditions. The study, from Orebro University in Sweden, is published in the journal Infection and Immunity. It surrounds the activity of a bacterium called Porphyromonas gingivalis, a well-known culprit in the development of periodontitis - a serious gum infection that damages the soft tissue that surrounds the teeth and attacks the bone that supports them. The team found that P. gingivalisalters the expression of genes that code for proteins that boost inflammation and atherosclerosis in the coronary arteries - the vessels that supply blood to the heart.
Lab-Grown Kidneys Work in Animals
Scientists say they are a step closer to growing fully functioning replacement kidneys, after promising results in animals. When transplanted into pigs and rats, the kidneys worked, passing urine just like natural ones. Getting the urine out has been a problem for earlier prototypes, causing them to balloon under the pressure. The Japanese team got round this by growing extra plumbing for the kidney to stop the backlog,PNAS reports.
Public Health and Patient Safety
FDA Advisers Urge Approval of New Flu Vaccine for Seniors
A US Food and Drug Administration (FDA) advisory panel has recommended approval of Fluad (Novartis), a new influenza vaccine that promises to offer enhanced effectiveness in patients aged over 65 years. The Vaccines and Related Biological Products Advisory Committee voted 11-1 that the vaccine was effective and 10-2 that it was safe, with one member abstaining from both votes. The FDA usually follows its panels' advice.
Fluad, made by Novartis Vaccines and Diagnostics, is an inactivated, trivalent vaccine. Unlike the 12 currently available flu vaccines for people aged over 65 years, Fluad contains an adjuvant designed to stimulate a greater immune response. Novartis is seeking accelerated approval, which means it will have to conduct a postmarketing trial to confirm the vaccine's clinical benefit.
Vaccine Offers New Hope for Removing Precancerous Cervical Lesions
Scientists have used a genetically engineered vaccine to successfully eradicate high-grade precancerous cervical lesions in nearly half of women who received the vaccine in a clinical trial. The goal, say the scientists, was to find nonsurgical ways to treat precancerous lesions caused by HPV. "Every standard therapeutic option for women with these lesions destroys part of the cervix, which is particularly relevant for women of childbearing age, who may then be at risk for pre-term birth due to a weakened cervix," said Dr. Cornelia Trimble, professor of gynecology and obstetrics, oncology, and pathology at the Johns Hopkins University School of Medicine, and first author of the new report, which appeared online Sept. 17 in The Lancet. "A vaccine able to cure precancerous lesions could eventually be one way women can avoid surgery that is invasive and can also harm their fertility."
Source: Source: http://www.newswise.com/articles/view/640044/?sc=mwhn
Influenza Vaccination Coverage among Pregnant Women — United States, 2014–15 Influenza Season
Flu is more likely to cause severe illness in pregnant women than in women who are not pregnant. Pregnant women with flu also have a greater chance for serious problems for their unborn baby, including premature labor and delivery. Flu vaccination is the first and most important step in protecting against mothers and their unborn babies against the flu. A provider recommendation combined with an offer to administer the flu vaccine at the time of visit remains one of the best ways to increase flu vaccination among pregnant women. Pregnant women and infants are at increased risk for influenza-related complications. The risk of influenza among pregnant women and their infants age <6 months can be reduced by vaccinating pregnant women. During the 2014–15 influenza season, 50.3% of pregnant women were vaccinated before or during pregnancy, similar to the 2013-14 season. Women who received a provider offer of vaccination had substantially higher vaccination coverage than those who did not receive an offer of vaccination. Barriers to vaccination included negative attitudes about safety and efficacy of influenza vaccination and unfounded concern that vaccination would cause influenza. Influenza vaccination coverage among pregnant women increased substantially during the 2009–10 influenza season and the increased coverage was sustained during the 2010–11 through 2013–14 seasons.
New Group of Antibiotics Kills Drug-Resistant Staph Infection
The Centers for Disease Control and Prevention (CDC) estimates that two million people are infected with an antibiotic-resistant bacteria every year. Now, a new group of antibiotics has shown promising results against a deadly bacteria. The new antibiotics focus on Staphylococcus aureus, or staph, and MRSA (methicillin-resistant Staphylococcus aureus). A team from Virginia Tech are already finding promising results with the new group, saying that the drugs have proven to be nontoxic in animal models. “The biggest question scientists have to ask to tackle antibiotic resistance is, how can we stay on top of the bacteria? Fortunately, these new organometallic antibiotics are coming at a time when bacteria have not evolved to resist them,” corresponding author Joseph Merola, a professor at Virginia Tech’s Fralin Life Science Institute, said in a news release.
Combo of 3 Antibiotics Can Kill Deadly Staph Infections
Three antibiotics that, individually, are not effective against a drug-resistant staph infection can kill the deadly pathogen when combined as a trio, according to new research. The researchers, at Washington University School of Medicine in St. Louis, have killed the bug -- methicillin-resistant Staphylococcus aureus (MRSA) -- in test tubes and laboratory mice, and believe the same three-drug strategy may work in people. "MRSA infections kill 11,000 people each year in the United States, and the pathogen is considered one of the world's worst drug-resistant microbes," said principal investigator Gautam Dantas, PhD, an associate professor of pathology and immunology. "Using the drug combination to treat people has the potential to begin quickly because all three antibiotics are approved by the FDA." The study is published online Sept. 14 in the journal Nature Chemical Biology. The three drugs -- meropenem, piperacillin and tazobactam -- are from a class of antibiotics called beta-lactams that has not been effective against MRSA for decades.
Experimental Ebola Drug ZMapp Gets Fast Track Status from FDA
ZMapp, an experimental drug that was given to the first American treated in the United States for Ebola, has been granted fast track approval by the FDA, according to LeafBio. LeafBio is the commercial arm of Mapp Biopharmaceutical, the makers of the drug. A press release posted on the company website proclaimed this as an "important milestone" which brings them closer to eventually gaining FDA approval. "We are gratified to receive this designation for ZMapp," said Dr. Kevin Whaley, CEO of LeafBio and Mapp. "We are hopeful that this step will accelerate access to ZMapp once safety and efficacy are demonstrated to FDA's satisfaction in ongoing clinical trials." This is a change from the previous status as an orphan drug, which provided incentive for development of the drug financially and otherwise.
The Bacteria-Fighting Super Element That’s Making a Comeback in Hospitals: Copper
Ancient Egyptians used copper to sterilize chest wounds and drinking water. Greeks, Romans and Aztecs relied on copper compounds to treat burns, headaches and ear infections. Thousands of years later, the ancient therapeutic is being embraced by some hospitals because of its ability to kill bacteria and other microbes on contact, which can help reduce deadly infections. At least 15 hospitals across the country have installed, or are considering installing, copper components on “high-touch” surfaces easily contaminated with microbes — faucet handles on sinks, cabinet pulls, toilet levers, call buttons and IV poles. Copper can kill or inactivate a variety of pathogens by interacting with oxygen and modifying oxygen molecules. In bacteria, this disrupts the outer layer, damaging the genetic material and cell machinery, which can lead to cell death. A recent study found that copper also destroys norovirus. There has been only one published clinical trial showing how copper reduces infections in hospitals. The results, however, were striking: Researchers said the study, which took place between July 2010 and June 2011, showed that copper surfaces reduced infection rates by 58 percent. Now, the CDC is pressing for more research.
Undiagnosed Diseases Network Launches Online Application Portal
The Undiagnosed Diseases Network (UDN), a clinical research initiative of the National Institutes of Health, has opened an online patient application portal called the UDN Gateway. Introduction of this application system sets the stage for the network to advance its core mission: to diagnose patients who suffer from conditions that even skilled physicians have been unable to diagnose despite extensive clinical investigation. These diseases are difficult for doctors to diagnose because they are rarely seen, have not previously been described or are unrecognized forms of more common diseases. The new system streamlines the application process. All applications for the UDN will go through the Gateway, rather through individual clinical sites in the network. The Gateway replaces what had previously been a paper-and-mail application process for the NIH Undiagnosed Diseases Program (UDP), which is now part of the UDN.
Measuring and Improving Patient Safety through Health Information Technology: The Health IT Safety Framework
Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings.
ONC Issues Guidance for Consumer-Centric Telehealth Visits
A new whitepaper from the Office of the National Coordinator for Health IT outlines the essential factors in a consumer-centered telehealth experience. The document grew out of a meeting last April in which more than 30 stakeholders focused on one of four scenarios: rural access to care; after-hours urgent care; post-acute passive monitoring; and chronic care passive monitoring. The authors developed a model showing how diffusion of clinical data and care can create safety concerns and risk higher overall costs. That model shows four possibilities:
- Integrated care with a primary care provider in which all clinical data is kept together
- Telehealth-enabled with the same PCP
- Extended integration with other providers in the network, but data integrated back in the record
- "Outside care," including one-off telehealth visits with providers with whom patients have no previous relationship
The latter scenario provides the greatest risk of fracturing care and data, according to the report.
Big Pharma Hands Out Fitbits to Collect Better Personal Data
Pharmaceutical companies are enlisting Fitbits and other gadgets strapped to patients’ wrists, chests and skin as a way to bring drugs to market faster. What began as an aid for athletes and dieters to track their movements is quickly becoming a critical tool for medical researchers and drugmakers. By outfitting trial participants with wearables, companies are beginning to amass precise information and gather round-the-clock data in hopes of streamlining trials and better understanding whether a drug is working. Down the line, wearables also could help pharmaceutical makers prove to insurance companies that their treatments are effective, thus reducing health costs.
Laboratory Medicine Education at U.S. Medical Schools: A 2014 Status Report
From 2013 to 2014, the authors surveyed the appropriate dean, department chair, or undergraduate education director at each U.S. medical school accredited by the Liaison Committee on Medical Education about the state of laboratory medicine education, curriculum and competency assessment, and barriers to education at his or her institution. The authors received 98 (75%) responses. Eighty-two schools (84%) offered course work in laboratory medicine; 76 (78%) required it. The median number of hours of required course work was 12.5, with 8.0 devoted to lectures and 4.5 to small-group, problem-based learning and/or laboratory sessions. Only 8 schools required training in a clinical setting. Fewer than half reported regular, formal review of the laboratory medicine curriculum.
Conclusions: Significant opportunities exist to improve laboratory medicine education, including in the proper use and interpretation of clinical laboratory testing.
Global Clinical Laboratory Market Is Expected to Reach USD 148.82 Billion By 2020
Growing prevalence of chronic diseases and the development of novel laboratory testing methodologies is expected to drive the clinical laboratory tests market through to 2020. Due to the fact that results from clinical laboratory tests are the fundamental basis upon which medical practitioners and healthcare providers form their diagnosis and prognosis for the prevention and treatment for a range of diseases, clinical laboratory tests are critical to the global healthcare and medical fraternity. A growing global prevalence of medical conditions such as diabetes, obesity and other metabolic abnormalities coupled with increasing patient awareness levels is expected to boost market growth during the forecast period.
Clinical NGS Market in China Poised to Take Off as China FDA Looks to Establish Guidelines
The clinical next-generation sequencing market in China is poised to take off, according to experts in the field. Noninvasive prenatal testing currently makes up the majority of NGS-based clinical tests, but preimplantation genetic screening and diagnosis and cancer testing are close behind, and strides are being made in rare disease testing as well. The market is "moving very fast," Sijia Lu, CEO of Yikon Genomics, told GenomeWeb. "Two years ago, almost no hospitals were using" NGS. Now, most hospitals in major cities have NGS capacity and many offer NIPT, he said. Last year, in response to the rapidly growing field, the China Food and Drug Administration decided that genetic tests must be approved, essentially halting the field. Companies had to stop offering their clinical NGS assays and submit applications to the CFDA for clearance of the NGS instrument and assay itself.
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