The Observatory

June 22, 2017

Arthritis in America

50 million
Is the number of people in the U.S. with doctor-diagnosed arthritis.

20%
Is the proportion of the adult population (over 18) with doctor-diagnosed arthritis.

Almost 50%
Is the proportion of adults over age 65 with arthritis.

78 million
Is the number of Americans expected to have doctor-diagnosed arthritis in 2040.

300,000
Is the number of babies and children who have arthritis.

31 million
Is the number of Americans with osteoarthritis.

172 million
Is the number of work days lost to osteoarthritis and rheumatoid arthritis alone each year.

$156 billion
Is the amount of money spent in arthritis-related lost wages and medical expenses each year.

100 millon
is the estimated number of arthritis-related doctor visits each year.

6.7 million
is the annual number of arthritis-related hospitalizations.

757,000
Is the number of knee replacement surgeries performed (2011).

512,000
Is the number of hip replacement surgeries performed (2011).

Source:Arthritis Foundation “Arthritis Facts.” http://www.arthritis.org/about-arthritis/understanding-arthritis/arthritis-statistics-facts.php

Antibiotic Resistance

Increasing susceptibility of Staphylococcus aureus in the United States. Findings from a study that looked at susceptibility trends of Staphylococcus aureus in U.S. hospital patients showed that key antibiotics used to treat the bacteria became more active over the course of the study, a rare occurrence. Researchers at JMI Laboratories evaluated susceptibility trends of antibiotics from 2009 to 2015 by testing clinical isolates from medical centers across the country.

“Results showed that S. aureus’ rates of resistance to certain antibiotics decreased over time, which isn’t often seen,” says presenting author Helio S. Sader, MD, PhD. The rates of S. aureus being resistant to oxacillin (MRSA) decreased from 47.2 percent in 2009 to 43.6 percent in 2015, and more recent data from this program showed a further decrease to 42.2 percent in 2016.

Resistance to other antibiotics, such as levofloxacin, clindamycin, and erythromycin, also showed some decrease during the same period, whereas susceptibility to ceftaroline, trimethoprim-sulfanethoxazole, and tetracycline remained stable. Furthermore, ceftaroline remained very active against methicillin-resistant S. aureus (MRSA) (97.2 percent susceptible) and methicillin-susceptible S. aureus (100.0 percent susceptible) with no marked variations or trends during the study period. One important result is that S. aureus resistance to daptomycin, linezolid, vancomycin, and tigecycline remained extremely rare, with no sign of increasing.

Researchers tested a total of 19,036 clinical isolates from 42 U.S. medical centers to determine how susceptible S. aureus would be to antibiotic agents. JMI used broth microdilution methods, the gold-standard method, to test susceptibility. Medical center staff participating in the Alliance Working for Antibiotic Resistance Education (AWARE) program followed a common study protocol to send collected bacterial isolates to JMI Laboratories to test how susceptible the isolates were to specific antibiotics.

Infectious Diseases

Scientists develop test to identify best treatment for gonorrhea. UCLA researchers have developed a laboratory test that helps physicians determine which patients with gonorrhea may be more treatable with an antibiotic that has not been recommended since 2007 because of concerns that resistance to the drug was growing. Gonorrhea has developed increasing resistance to all current antibiotics.

Ciprofloxacin was used to combat the sexually transmitted infection until 2007, when the CDC stopped recommending its use after gonococcal infections developed resistance to it. Nevertheless, about 80 percent of gonorrhea infections in the United States could be treated with ciprofloxacin. Scientists have been trying to determine how to better identify cases for targeted use of ciprofloxacin therapy, reducing the need to use the antibiotic ceftriaxone and risking increased resistance to that drug. Gonorrhea’s resistance rate to ceftriaxone is currently less than one percent.

The research was conducted at UCLA Health’s hospitals, emergency departments, and primary care clinics. After developing a test to detect a genetic change in gonorrhea that makes it resistant to ciprofloxacin, the researchers noted what treatments UCLA physicians had been using to treat gonorrhea. They then used the new test for all gonorrhea cases over a nine-month period and compared treatments before and after test introduction.

Based on the results from the new DNA test, physicians appropriately changed treatment choices, decreasing the use of ceftriaxone from 100 percent of the time to 66 percent. Correspondingly, the use of ciprofloxacin increased from 0 percent to 34 percent of cases.

These findings are important because there are a limited number of medications to treat gonorrhea. Reusing previously effective antibiotics and decreasing the use of ceftriaxone may slow down the continued emergence of antibiotic resistance.

A quarter of nursing home residents are colonized with drug-resistant bacteria. According to researchers, the significant presence of multidrug-resistant gram-negative bacteria. (MDR-GNB), such as E. coli, among nursing home residents demonstrates the need for heightened infection prevention and control measures in nursing homes. A systematic literature review and meta-analysis, conducted by researchers at the Columbia University School of Nursing, found the prevalence of MDR-GNB colonization among sampled nursing home residents ranged from 11.2 percent to 59.1 percent, with a pooled average of 27 percent.

The researchers also found that nine of the 12 studies involved identified specific factors that are associated with increased MDR-GNB colonization risk, including advanced age, gender, co-morbid chronic diseases, history of recurrent hospitalization, increased interaction with healthcare workers, frequent antimicrobial exposure, delayed initiation of effective antibiotic therapy, presence of medical devices, decreased functional status, advanced dementia, fecal incontinence, non-ambulatory status, severe sepsis present on admission, and residency in a long-term care facility.

Nursing home residents are especially vulnerable to infections due to multiple co-morbidities, advanced age, and immune dysfunction. In addition, living in a nursing home is itself considered a risk factor, as frequent transfers from nursing homes to acute care contribute to the influx of pathogens into hospital settings. Prevention and management of MDR-GNB in nursing homes are complicated and require extensive infection control resources due to challenges common to this setting such as understaffing, fewer resources, insufficient training, and inadequate surveillance.

Genetics/Genomics

NIH researchers find potential genetic cause of Cushing syndrome. A small study by researchers at the National Institutes of Health (NIH) suggests that mutations in the gene CABLES1 may lead to Cushing syndrome, a rare disorder in which the body overproduces the stress hormone cortisol. The study appears online in Endocrine-Related Cancer.

The excess cortisol found in Cushing syndrome can result from certain steroid medications or from tumors of the pituitary or adrenal glands. Symptoms of the disease include obesity, muscle weakness, fatigue, high blood pressure, high blood sugar, depression and anxiety.

Researchers at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in collaboration with researchers at other institutions in the United States, France, and Canada, scanned tumor and cell tissue from 146 children with pituitary tumors evaluated for Cushing syndrome at the NIH Clinical Center. Researchers also scanned the genes of tumors from some of the children. Investigators in France scanned the genes of an additional 35 adult patients with Cushing syndrome and pituitary tumors.

The research team found that four of the patients had mutant forms of CABLES1 that do not respond to cortisol. This is significant because, when functioning normally, the CABLES1 protein, expressed by the CABLES1 gene, slows the division and growth of pituitary cells that produce the hormone adrenocorticotropin (ACTH). In turn, ACTH stimulates the adrenal gland to produce cortisol, which then acts on the pituitary gland to halt the growth of ACTH-producing cells, effectively suppressing any tumor development. Because cortisol does not affect the four mutant forms of CABLES1 discovered by the researchers, these genes leave production of ACTH-releasing cells unchecked.

Zika Virus

Mobile app to test ZIKV. Researchers at Sandia National Laboratories have developed a smartphone-controlled, battery-operated diagnostic device that weighs under a pound, costs as little as $100, and can detect Zika, dengue, and chikungunya within 30 minutes.

Smartphone technology is a key feature of the device. “In addition to creating an app that serves as a simple interface to operate the device, we were able to adapt smartphone camera sensors to replace traditional laboratory sample analysis tools, allowing for unprecedented mobility,” chemical engineer and lead author Aashish Priye says.

The Sandia team’s device is based on the loop-mediated isothermal amplification (LAMP) diagnostic method, which eliminates the need to process a biological sample such as blood or urine before testing. Conventional viral testing involves transporting a sample to a laboratory, extracting DNA or RNA from it, and then multiplying the genetic materials through polymerase chain reaction (PCR). This process involves heating and cooling the sample many times, so that any viral DNA/RNA in the sample is replicated enough to be detected.

Repeatedly heating and cooling the sample is power-intensive and demands the complexity of PCR machines. Detection of the copied viral material also requires expensive components such as fluorimeters. The complexity and expense of traditional PCR machines have been major hurdles in moving PCR devices outside of laboratories and into the clinics where they are most needed.

Like PCR, LAMP copies viral DNA/RNA, but without the heating and cooling cycle a heavy-duty power source isn’t needed. The addition of a few carefully designed biochemical agents allows a LAMP box to test a sample that is heated only once to 65 degrees Celsius (150 degrees Fahrenheit) for half an hour.

For the Zika project, researchers developed a novel algorithm that allows a smartphone sensor to act as a fluorimeter, detecting QUASR LAMP light signals if they appear. The user need only place the smartphone on top of the LAMP box and open an app. The app turns on the heater to initiate the LAMP reaction.

Once the 30-minute testing period is up, the smartphone photographs the sample. The app then employs a novel image analysis algorithm to accurately determine the color and brightness of the glow emitted from the LAMP reaction. This smartphone-based image analysis offers much greater detection certainty than the naked eye.

Industry News

Robots becoming essential for the clinical diagnostic lab. There is an $8.8 billion market for robotic laboratory automation systems, according to Kalorama Information. The healthcare research firm just completed a report on lab robots, and notes the imbalance between the high demand for diagnostics and the lack of supply of qualified technicians.

“More than two-thirds of clinical decisions are based on laboratory test results, and new tests are developed constantly,” says Bruce Carlson, Publisher of Kalorama Information. “But a shrinking field of qualified laboratory personnel, while demand grows, requires something to handle the tasks created.”

Kalorama Information covered the market for lab robotics in its report Robotic Lab Automation. In the report, the firm notes that many labs performing medical sample analyses still use manual distribution systems. The process starts first when the data for the incoming samples is captured. The samples are then placed in racks in batches, carried by employees to the various analysis stations, and, if necessary, re-sorted from time to time for further analyses. Labor, notes Kalorama, is still about 60 percent of the cost of lab services.

Robotic technology can be harnessed to completely automate the work flow process. There are many laboratory processes suited for robotic automation —namely those processes that entail repetitive movements, such as pick and place, heating and cooling specimens, and mixing, shaking, and testing specimens. Essentially, laboratory robots manage specimen tubes, prepare them for testing, and allow for sample tracking throughout the testing process, from collection to results. The systems have various modules that participate in sample preparation, transport to analytical instruments—such as hematology, chemistry and immunoassay analyzers—and post-analytical storage. Each module often includes several units, such as decappers, sorters, centrifuges, analyzers, and refrigerators.

Task-targeted robotic systems are custom designed and configured for specific applications, often pre- and post-analytical processes. Generally, commercial off-the-shelf (OTS) systems do not exist for many complex and proprietary lab operations. To eliminate any inconsistencies and shorten the time for technicians waiting to get their desired test results, these application-specific systems can be designed and constructed.

Task-targeted robotic systems are custom designed and configured for specific applications, often pre- and post-analytical processes. Generally, commercial off-the-shelf (OTS) systems do not exist for many complex and proprietary lab operations. To eliminate any inconsistencies and shorten the time for technicians waiting to get their desired test results, these application-specific systems can be designed and constructed.