SOARING TO NEW HEIGHTS: YOUNG DANCER CONQUERS RARE, DEBILITATING DISEASE AND NOW TRAINS AMONG THE WORLD’S ELITE
Published in the Fall 2019 Duke Children’s Hospital Stories Magazine
By Whitney J. Palmer
At 10 years old, Clark Eselgroth’s dream was coming true—he had won the role of Fritz, the main young male lead in The Nutcracker. He was set to be on stage, performing one of the most famous parts in all of classical ballet.
But, that dream wouldn’t come to fruition. By the time rehearsals began, Clark was on crutches due to pain so intense in his hips and his leg that it disrupted his sleep. Some days, he could barely walk. Not only were his hopes of dancing in The Nutcracker dashed, but his lifetime goal of becoming a professional dancer was in jeopardy.
“Clark would wake up in the middle of the night, crying in pain,” says Amy Milne, his mother. “We took him to our local pediatrician, and things escalated quickly because this wasn’t normal in a child.”
CHASING CLARK’S DIAGNOSIS
Attempts by his sports medicine doctor and regular pediatrician in Asheville to treat Clark for tendinitis or overuse injuries, as well as control the pain with naproxen, failed. Then, his pediatric orthopaedist ordered an MRI. The image lit up bright white with bone lesions covering areas where he felt pain and several where he didn’t. Fortunately, a bone biopsy ruled out cancer.
That left one possible diagnosis—chronic recurrent multifocal osteomyelitis (CRMO), also known as chronic non-bacterial osteomyelitis. This non-infectious auto-inflammatory disease causes bone lesions that can produce debilitating pain. It is a rare disorder—several hundred cases have been reported in the literature, but the incidence of the disease is unknown. Lesions, which can be mistaken for malignancies and delay diagnosis and treatment, can appear anywhere, but the most serious are on the spine and growth plates. Left untreated, they can lead to spinal collapse and stunted growth. Affected children also have an increased risk of psoriasis; inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis; arthritis; and eye disease.
With a referral from an adult rheumatologist, Clark’s family sought out specialized treatment from Duke pediatric rheumatologist Jeffrey Dvergsten, MD. Duke is one of only three institutions in North Carolina that treats CRMO. During the first appointment, in December 2012, he confirmed Clark’s diagnosis and launched him down a more targeted therapy path.
DANCING THROUGH THE PAIN
When Clark arrived at Duke, he had been on crutches intermittently for three months. He was limping, had lost significant range of motion, and was taking only naproxen for pain relief. Dancing was sidelined.
“Clark had given up dance temporarily because it was too painful,” Milne says. “CRMO is a really deep bone pain that you can’t massage away. It’s extremely hard to provide comfort until you get medication that causes the inflammation to subside.”
But, after Dvergsten found the right mix of prescription medications, which included combining a higher dose of nonsteroidal anti-inflammatory drugs (NSAIDs) with the anti-inflammatory sulfasalazine, Clark returned to training quickly, enrolling in the International Ballet Academy in Cary. The frequent drives to the Triangle for training and treatment, though, eventually led the family to move to Cary, making it easier for him to balance school, training, and controlling his CRMO.
And, as Clark perfected his skills, more opportunities arose. At age 11, he was accepted a year early to a six-week summer intensive program in Houston. According to Milne, the camp marked the beginning of his serious ballet instruction.
His training progressed uninterrupted, except for normal childhood injuries, including a broken arm, until 2015 when Clark hit a growth spurt. Rapid growth can kick-start a CRMO flare, tricking the body’s autoimmune system into thinking something is wrong with the bones. As a result, Clark developed a second round of inflammation, lesions, and pain. This flare threatened his dancing career.
An MRI showed not only new lesions, but it also revealed a secondary diagnosis. Clark had sacroiliatis, arthritis that attacks the lower back and pelvis, creating pain in the buttocks, lower back, and down the legs. Treating him more aggressively was critical to preserving his dancing dream.
“And, his arthritis would have, over time, caused the joints affected by that condition to fuse.”
CLARK’S TREATMENT
To combat both conditions, Dvergsten prescribed etanercept, a weekly injectable protein that combats inflammation. Over time, as patients improve and stabilize, they can wean off the medication.
Clark followed the weekly regimen for more than two years. The same lesions appeared on his 2017 MRI, but etanercept had his pain under control. By January 2018, everything was clear, Dvergsten says, and he scaled Clark’s dose back to every 14 days. He’s remained stable and is anticipated to switch to an injection every 21 days once there’s a break in his rigorous training schedule.
IMPACT ON TRAINING
Thanks to these treatments, Clark was able to travel, on scholarship, to complete a 10-day training program in Australia in 2018. Shortly thereafter, he was also offered scholarships to train in Monaco and with The Royal Ballet School in London.
Today, Clark, at 16, is in the first year of a three-year training program with The Royal Ballet School Upper School in London. While there, he’s continuing his treatment without interruption. The school nurse keeps his injections refrigerated, and Clark administers them himself. The school also assigned him only one roommate—instead of three—to minimize his exposure to viruses.
The instruction he’s receiving is advanced, and he credits the treatment he received at Duke to control his pain with his ability to continue training at such a high level. It also played a significant role in his learning to handle any setbacks that come his way.
“I learned you don’t always get a say in what your body is doing, or is capable of, and patience is more important than any other thing—ever,” Clark says. “If I hadn’t been able to get past roadblocks like CRMO flares or wait patiently for injuries to heal, I wouldn’t be where I am today. I wouldn’t be as smart about dealing with problems.”
Ultimately, Clark says, the treatment he received at Duke to control his CRMO pain allowed him to grab the chance to study and excel at The Royal Ballet School when that door opened. And, it’s helped him maximize his time in London—when he graduates, he hopes to have the opportunity to be considered to join The Royal Ballet.
“It’s opportunity after opportunity here. Having a chance to see the company perform regularly is a dream come true,” Clark says. “It’s my favorite company in the world. I wouldn’t trade this for anything.”
To read the article at its original location: https://giving.dukechildrens.org/stories/soaring-to-new-heights
What’s New in Mammography
Published on the Oct. 22, 2019, DiagnosticImaging.com website
By Whitney J. Palmer
For decades, mammography has stood alone as the gold standard for breast cancer screening and detection. But, being the go-to strategy for identifying the early-stage or advanced cancers isn’t enough. Work has continued to not only augment the efficacy of mammography, but to also increase its use and reach.
Industry-wide, there are efforts underway to design and implement new technologies and strategies for mammography. And, research is also revealing new ways for the modality to make an impact on saving lives.
Since its creation, mammography has largely been a one-size-fits-all technology, leading to many patient complaints about discomfort and pain. In many instances, these worries have prevented women from scheduling the screening exam. And, to increase utilization, some companies have created horizontal mammography machines; others have added heaters so paddles aren’t so cold.
But, just as each woman is different, so is each breast. One product designed to help meet individual needs is Solis Mammography’s SmartCurve by Hologic, a mammogram paddle that can provide a more personalized screening experience. The curved paddle form fits to the breast, more easily accommodating most patients.
According to Stacy Smith-Foley, MD, medical director for the Breast Center at CARTI, this technology can benefit both providers and patients. The Center has used SmartCurve as the standard for all patients since April of this year.
“On the technical side, technologists can position patients in ways that can include much more tissue than they can with a standard paddle,” she says. “And, for patients, due to the curvature of the paddle, the force of compression is more evenly distributed across the breast.”
Although the curved paddles don’t work well for capturing implant displaced views in women who have breast implants, they do offer benefits for most patients. Improve positioning for the majority of women reduces the number of images needed for diagnosis, and fewer images leads to less radiation exposure, Smith-Foley says.
Alongside the patients, she adds, SmartCurve has also offered her technologists some benefits. While the technology allows them to better position patients, it also keeps them in better ergonomic positions, as well. Their body mechanics improve, and they experience more comfort and less pain throughout the work day, she says.
To read the remainder of the article at its original location: https://www.diagnosticimaging.com/mammography/whats-new-mammography
The New Wave of Diabetes Management: Monitoring Technologies Surge as Disease Prevalence Mounts
Published in the October 2019 Clinical Laboratory News, American Association of Clinical Chemistry
By Whitney J. Palmer
Big data and bioengineering advances are fueling rapid changes in diabetes technologies, which offer the promise of better self-management and quality of life for individuals with the disease, and easier care oversight by physicians. With the incidence of diabetes rising, these innovations are coming into use when “the ability of an individual living with diabetes to have human-to-human contact with their healthcare provider is not keeping pace with the number of people developing diabetes,” according to a recent review.
Continuous glucose monitors (CGM) and related sensor, pump, and information technologies have taken off, with patients embracing the empowerment they offer to self-track and manage glucose levels throughout the day. Between 30% and 40% of individuals with type 1 diabetes—and a growing number of those with type 2 diabetes—use CGMs. Manufacturers continue to refine these complex systems, but challenges remain around wider adoption and correct use of this evolving technology.
“These are mainly outpatient tools, and we’re not sure how useful they will be for treating patients,” said David Klonoff, MD, medical director of the Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Medical Center in San Mateo, California, and the founder and president of the Diabetes Technology Society. “The technology may turn out to be extremely useful. It’s under investigation right now.”
DEMAND DRIVERS
Several factors are pushing demand for CGMs and their associated systems, said Roman Hovorka, PhD, professor of metabolic technology at the University of Cambridge in the U.K. Patients and providers are looking for management devices that seamlessly pair glucose sensing and insulin delivery to control glucose levels more efficiently around the clock. These tools help individuals make better food and activity choices to better maintain normal glucose levels, he suggested.
Noninvasive convenience is also driving CGM use, according to Klonoff. Many patients struggle with gathering blood samples via fingerprick several times daily. This benefit also applies to other wearable technologies, such as patches and microneedle devices. “People don’t want to prick their fingers very much, and no one can prick their finger enough times a day to identify every time their blood sugar is too high or too low,” he said.
Improved connectivity and user experience also are prompting more people to jump aboard the CGM bandwagon. Bluetooth technology transmits glucose readings to patients’ smartphones which then transmit the data to electronic medical records for clinician review or to pediatric patients’ parents.
CURRENT AND FUTURE TECHNOLOGIES
CGM products have been available for approximately 20 years, offering an alternative to standard blood glucose monitoring systems that rely on fingerprick samples. In recent years, they’ve improved in accuracy and ease-of-use, said Klonoff, though still need refinements.
Overall, CGM devices are considered either “open loop” or “closed loop” (Table 1). Open-loop monitors measure glucose levels subcutaneously at regular intervals, generally every 1 to 5 minutes. Users in most cases still have to self-check and calibrate their values via capillary blood glucose readings and adjust their insulin pump settings based on data from the monitor.
As well-accepted as open-loop systems are becoming, the future of CGM technology lies with closed-loop systems, also called an artificial pancreas, according to experts. Designed to mimic a healthy pancreas, these systems, only one of which—the Medtronic 670G—has been approved for use in the U.S., meld glucose sensing technology with insulin pumps (Table 2). Supported by special algorithms, they analyze glucose levels and determine appropriate insulin doses, which users need to check and confirm before they are administered. Single-hormone systems provide only insulin; double-hormone systems will offer insulin and glucagon.
For users, an artificial pancreas provides the full circle-of-care from immediate glucose management to clinician involvement, said Hovorka. “It’s the combination of more diabetes monitoring technologies and more collection of data that can be pushed into a system that can share information with healthcare professionals and with guardians and loved ones that is making these systems and devices as usable as possible,” he elaborated.
To that point, a recent American Diabetes Association review of diabetes technologies stressed that optimal use of either standard blood glucose monitoring systems or CGMs depends on both users and providers reviewing and interpreting these devices’ data output (Ann Intern Med 2019; doi:10.7326/M19-1638).
Ongoing work will make these systems smaller, Klonoff added, and they likely will deliver a more concentrated form of insulin currently under development. Additionally, future generation artificial pancreas systems will require fewer component replacements, fewer recalibrations, and less meal-time bolus insulin, predicted Natalie Allen, MD, a pediatric endocrinology and metabolism fellow at Virginia Commonwealth University in Richmond.
CHALLENGES AHEAD
According to Michael Hill, vice president of science, technology, and clinical affairs at Medtronic, the CGM market is currently growing between 20% to 30% annually, but the technology still presents challenges. “From customers, we always get feedback to make these tools smaller and last longer,” he said. “And there’s always the request to make them easier to use, particularly for kids and elderly patients.”
Like most new technologies, the devices can be cost prohibitive for patients who are un- or under-insured. Not only must they pay the initial sensor and transmitter costs, but they also shoulder the weekly, monthly, and yearly replacement expenses. These costs—and the projected benefits of CGM—would need to be weighed against the purchase of test strips for and level of glycemic control possible with standard blood glucose monitoring.
Additionally, interstitial glucose level measurements lag bloodstream measurements by approximately 10 minutes, and exercise can make it harder to secure accurate real-time readings, Allen cautioned.
A review Hovorka co-authored found that the latest sensor technologies have a mean absolute relative difference (MARD) versus lab-based tests of 8% to 14%, but that “accuracy is lower when measuring in the [hypoglycemic] range and when glucose levels are changing rapidly.” He added that with a MARD <10%, these systems are accurate enough “to allow patient self-adjustment of insulin dosage without confirmatory capillary blood glucose measurements” (Nat Rev Endo 2018;14:464-75).
Early studies of the Medtronic 670G hybrid closed-loop system show that users had improved HbA1c levels and time in range. However, research also suggests this technology is not a panacea: A small study of mostly pediatric patients found that nearly 40% stopped using this system mainly due to forced exits from the closed-loop automated basal delivery mode, frequent alarms, sensor supply and accuracy issues, and skin adhesion issues.
Cybersecurity involving CGMs is another concern, Klonoff said, because sensitive patient information is transmitted wirelessly to both families and clinicians. Further research is needed to ensure sufficient precautions exist to prevent data hacking.
In Hovorka’s view, perhaps the most dangerous challenge involves patients’ and families’ growing frustration with the progress of artificial pancreas development. Many have created do-it-yourself systems. In some cases, these closed-loop systems, pieced together with approved and unapproved components, have delivered unsafe amounts of insulin, and a case report of one system doing so prompted the Food and Drug Administration earlier this year to warn against their use. Consequent-ly, clinician-patient conversations about safety are critical, he emphasized.
MONITORING AND IMPROVING PERFORMANCE
While CGM devices make it easier for patients to control their day-to-day glucose levels, this infor-mation is best viewed as a trend over time, said James Nichols, PhD, DABCC, FAACC, medical director of clinical chemistry and point-of-care testing at Vanderbilt University School of Medicine in Nashville. Because the values are based on interstitial fluid readings, they are less precise than clinical laboratory measurements and are not robust enough to be used in treatment decisions.
“It’s important from a laboratory perspective that we engage physicians and let them know that continuous glucose monitors are not laboratory devices,” he stressed, adding that clinical and laboratory staff should assume glucose monitoring for patients admitted to hospitals. “These devices are not quality controlled the same way a glucose meter or a core laboratory analyzer are.”
Consequently, he said, it’s incumbent upon clinical laboratory professionals to ensure physicians understand the margin-of-error and accuracy differences between CGM and lab-based methods. With that knowledge, clinicians can appropriately educate patients on the importance of being engaged in their own diabetes care, teaching them how to use CGM devices to monitor themselves and dose their own insulin.
Accuracy challenges, in fact, cover the gamut of diabetes self-monitoring technologies. Klonoff and Nichols co-authored a study that found that just six of 18 standard blood glucose meters cleared for personal use met a predefined accuracy standard on three of three studies, while four did not meet this standard on any of the studies (Diabetes Care 2018;41:1681-8).
Clinical laboratory professionals also should play a broader role in improving CGM performance by being part of CGM product development, suggested Ping Wang, PhD, DABCC, FAACC, associate professor of pathology and laboratory medicine at The Hospital of the University of Pennsylvania in Philadelphia. “CGM vendors should reach out to clinical laboratory professionals to build CGM devices with better accuracy,” she said. “Rather than conducting retroactive studies to determine ac-curacy, the industry should be more proactive. Collaborating with clinical professionals can improve accuracy during the early phases of product development itself.”
Even with some imperfections CGM devices are valuable tools for better managing glucose levels, she suggested. “In many cases, these devices can predict an upcoming drop in glucose, triggering an alarm for the patient,” she said. “Even though the tools aren’t as accurate, that’s a benefit that a clinical lab can’t offer.”
To read the article at its original location: https://www.aacc.org/publications/cln/articles/2019/october/the-new-wave-of-diabetes-management
Comprehensive web-based veterinary PACS
By Whitney J. Palmer
Veterinary diagnostic imaging might comprise a fraction of all medical imaging use globally, but it’s still set to be a $3.27 billion market by 2025, according to market and consumer research firm Business Research, Co. From small veterinary practices to referral practices to hospitals, a growing number of facilities are expanding how they use digital imaging to maintain the highest level of pet care available.
In fact, more and more veterinarians, like their human-health counterparts, are realizing a picture archiving and communication system (PACS), such as PaxeraHealth’s PaxeraVet, is the most efficient tool to manage the ever-expanding volume of diagnostic images they produce and use on a daily basis.
Multiple factors are pushing this trend. Pet owners are asking veterinarians to use diagnostic imaging modalities, including MRI and CT, to pinpoint their fur babies’ ailments. Concerns continue to rise over cancer and tumors in smaller pets, fueling imaging use in neurology and oncology, as well as cardiology, orthopedics, and rehabilitation. And, as more pet owners purchase pet insurance, fewer are shying away from these costly exams.
PaxeraVet is a browser-based PACS solution that helps animal health providers effectively meet their treatment goals, offering many of the same capabilities available on human-health imaging systems. It supports all DICOM modalities and includes a veterinary-specific work list that is searchable by breed, species, and owner’s name.
Like all medical professionals, veterinarians need access to their patients’ medical histories. PaxeraVet gives providers a comprehensive timeline of a pet’s health by compiling each animal’s files into individual records. The system also enables viewing of two studies simultaneously on a split-screen, making it easy to compare prior and current images.
Thorough imaging reports also bolster the quality of veterinary care. To create the most information-dense records, PaxeraVet offers a reporting and transcription tool that allows users to insert images, add a customized facility logo, and include an auto header. Image processing tools also support the inclusion of filters, annotations, measurements, and details about region of interest and vertebral heart scoring.
When it comes to maximizing quality of care and collaboration, though, sharing images can be vital. Frequently, diagnostic findings can mandate sending an animal to a specialist. With PaxeraVet, general veterinarians can easily share anonymized or non-anonymized images with outside facilities through the system’s zero-footprint viewer.
With a click of a button, providers can generate unique links to specific studies, determine how long specialists can access the scan, and email the image. Special access or permission isn’t required, and the images will open on all devices, including PCs, MACs, tablets, and smartphones. Once the image is closed, all traces of the zero-footprint viewer disappear from the device.
Overall, PaxeraVet is a PACS designed to support veterinarians both in their day-to-day work flow and in cases where more specialized treatment is required. The ultimate goal is offering pet owners the highest quality of care is the most expedient way possible.
To read the article at its original location: https://PaxeraHealth.com/2018/02/16/comprehensive-web-based-veterinary-pacs/
How to Increase Reimbursements
Published on the March 15, 2018 DiagnosticImaging.com website
By Whitney J. Palmer
For the second year running, the coding and reimbursement world is relatively calm for diagnostic imaging. Instead of seeing massive payment cuts or a slew of changes to codes this year, you’re simply going to have to wait longer for your money.
But, even that lag time can cause problems, industry experts say.
Over the next several months, there are a few things you should watch for—they could add dollars to your bottom line.
National Correct Coding Initiative Edits
If you do many chest X-rays with abdominal studies, chances are you’ve noticed your claims have been denied all year. According to Maria Tran, assistant director of coding for the American College of Radiology (ACR), the reason is simple. The Centers for Medicare & Medicaid Services (CMS) included unannounced edits in the 2018 final rule.
It’s an oversight that took the industry by surprise, and its schedule will be corrected by April 1 as part of the National Correct Coding Initiative edits. Still, until that date, getting reimbursement for those claims will be difficult.
You do have options, however, to facilitate payment:
1. You can hold on to any chest X-ray with abdominal studies claims from January 1 to March 31 of this year and submit them after April 1.
2. You can continue to have your staff submit the claims, receive the denial, and correct the claim for re-submission.
3. You can code for the procedure differently. Instead of using 71045, single view chest X-ray, to code for the procedure, submit 74018, one view abdominal X-ray, with a -59 CPT modifier. Pursuing reimbursement this way will ensure you’ll receive payment for both services provided between January 1 and March 31.
If you work for a practice that operates in several states, though, be sure everyone is consistent, says Karna Morrow, diagnostic coding trainer for CSI Coding Strategies. Otherwise, some of you will get paid, and others won’t.
Most importantly, she says, choose a claim submission strategy that works best for you. Assess your financial situation and what might be most beneficial for your practice.
“Evaluate your operational needs and make a decision,” she said. “That way, you can make a conscious decision instead of just pushing everything out the door and getting denials.”
To read the remainder of the article published at its original location: http://www.diagnosticimaging.com/reimbursement/how-increase-reimbursements
Engage Employees, Improve Radiology Patient Experience
Published on the July 19, 2017, DiagnosticImaging.com website
By Whitney J. Palmer
In today’s health care environment, improved patient experience is a buzz phrase. It can determine your patient flow and your reimbursement levels. And, it depends on much more than simply providing appropriate care.
According to Michael Janis, MBA, RT, director of outpatient and ancillary services at HSHS St. Anthony Memorial Hospital in Effingham, IL, how engaged your colleagues are in their jobs and in your organization’s mission directly impacts the experience individual patients have. In fact, it can be crucial to your facility’s performance.
Maximizing colleague engagement depends on how well you explain your organization’s mission and values and how well employees understand your expectations for their performance. The clearer you are, the easier it is for them to fulfill your goals and augment the experiences your patients have, he said.
“Often, we get in the weeds with budgets and productivity, and we miss the need for engagement,” Janis said. “Remember that your colleagues want to feel connected to the hospital and its mission.”
But, with national data showing that only 30% of U.S. employees are actively engaged with their jobs, you will likely have to teach your employees how to be more invested in what they do. There are things you can do, though, that will ultimately lead to greater patient experiences.
Employee Engagement: Teach your employees that job satisfaction and happiness aren’t the same thing, he said. Their daily mood is irrelevant to whether they are satisfied in the workplace.
“Someone’s everyday day feeling isn’t an indicator. Colleagues must feel connected with the mission and values of the organization,” Janis said. “If they can’t connect with the organization’s values, then there are opportunities elsewhere.”
If they feel they’re operating within the mission and values, bad days are less likely to spill over into their performance with patients.
Patient Satisfaction: Overall, patients want to be satisfied with their experience and feel better. But, the language of health care can make it difficult for them to understand how to make changes and why they’re important. In radiology, having technologists who take the time to explain studies, tell the patient they’re washing their hands for safety, and discuss what will happen can greatly enhance how a patient walks away feeling about the encounter.
“It’s really not negotiable,” Janis said. “This is what we must do, and it must be done with a smile.”
To read the remainder of the article, click here.
Emergency Preparedness in Radiology
Published on the Oct. 5, 2017 DiagnosticImaging.com website
By Whitney J. Palmer
“All the roads were flooded in Houston around the hospital,” said Susan John, MD, chair of diagnostic and interventional imaging at the University of Texas Health Sciences Center. “No one came in or out after Saturday night, and the waters didn’t recede until Monday.”
That was the scene in the aftermath of Hurricane Harvey, a Category 3 storm that hit Houston in late August, causing massive destruction and city-wide flooding. In the middle of the havoc, though, medical personnel, including radiologists, continued to provide necessary patient care services.
Staying active during and following a hurricane is possible, she said. To do so, though, practices and departments must follow emergency protocols. In many cases, especially for radiologists affected by Harvey and Hurricane Irma, a Category 3 storm that struck south Florida in early September, these policies were the result of lessons learned from past experiences.
They can serve as a guide for you or others if you, one day, find yourself facing a hurricane. And, if you handle preparedness well, said Benjamin Freedman, MD, chief of radiology at Memorial Healthcare System in Florida, you’ll not only safeguard your quality of care, but you could also improve your relationships.
“Sharing a safe place really can serve to strengthen the relationship between the group of radiologists working together and the referring physicians, technologists, staff, and administrators,” he said.
Planning Personnel
Establish a coverage schedule well in advance of a storm, Freedman said. Don’t wait to assign shifts at the last minute — that creates unneeded stress and confusion. Additionally, plan to have enough providers and staff on-hand during the storm. Adequate personnel is critical, he said.
“It’s the natural inclination during a storm to have as few people at the hospital as possible to keep your staff safe,” he said. “But, you actually need enough people there so everyone working during the storm won’t get burned out over the several days everyone might be stuck in the hospital.”
Texas’s Heath Science Center, which serves Memorial Hermann Healthcare System and Lyndon B. Johnson Hospital, addressed this problem by relying on existing work schedules to assign hurricane coverage. Instead of creating new hurricane schedules, staff already scheduled to work when the hurricane hit stayed on call during the storm, John said. They were divided into two teams — ride out (those who stayed in-house and worked during the storm) and recovery (those who provided aftermath relief).
Communicate clearly, early, and often with your staff, she said, so they know which team they’re on.
“People need to have enough time to make arrangements for their families and to prepare themselves mentally, physically, and emotionally,” she said.
Changing teams can be tricky after a storm, said Kelly Burton, imaging manager for Houston Methodist Willowbrook Hospital. It can take a while for your recovery team to safely make it back to work, and you must maintain staffing until then. Her facility ensured enough staff were on hand by requiring ride out and recovery team members to physically “High 5” as they traded spots — that way, she said, everyone knew their replacement had arrived.
Work with IT Staff
Before any major storm hits, Freedman said, talk with your IT staff about any steps needed to strengthen your PACS system or how you or your colleagues might be able to provide services remotely.
In addition, work with IT personnel to disseminate all downtime procedures so everyone knows the process for continuing to provide care if your facility loses communication capabilities during the storm.
“We had a book of downtime procedures at every work station so if communications or power went down and we were dependent on a generator, our radiologists would still know what to do,” he said.
The handbook was helpful, he said, when one CT scanner lost contact with the Memorial PACS system. Instead of halting services, radiologists read and interpreted studies off the scanner itself.
To read the remainder of the article, click here.
Apremilast vs CF101 for Psoriasis
Published on the Nov. 16, 2016, Rheumatology Network website
By Whitney L. Jackson
Despite major steps forward in treating psoriasis over the past two decades, treatments can often take harsh tolls on the body, prompting some people to stop treatment. There’s a need, then, for new, convenient therapies that are both safe and effective, causing as little negative impact as possible.
Recently, a small molecule drug apremilast (Otezla), was approved to treat moderate-to-severe psoriasis. But, investigators are also looking into whether another mediation, CF101 (Piclidenoson), might have a longer-lasting positive effect. It’s an orally-bioavailable adenosine receptor that prompts an anti-inflammatory response, leading to the inhibition of tumor necrosis factor-⍺, interleukin -6 and -12, macrophage inflammatory proteins, and receptor-activator of NF-KB ligand.
According to the result of a Phase 2/3 multi-center, randomized, double-blind, placebo-controlled study with nearly 330 participants, published in the Journal of Drugs in Dermatology, researchers found apremilast and CF101 both offer safe, effective treatments. Apremilast outperforms CF101 through 16 weeks, but its benefits plateau at that point. CF101’s ameliorative impact takes hold at this point and carries on through 32 weeks.
Consequently, investigators determined, CF101 offers promise as an effective, long-term psoriasis treatment. And, the safety results support data from other Phase 2 CF101 studies that the drug is effective across different systemic inflammatory diseases. Other studies have also demonstrated CF101 is effective in treating rheumatoid arthritis after 12 weeks of therapy.
This is important because existing research shows the median survival for biologics in psoriasis was 47 months. Between 10% and 20% of patients experience a loss of biologics efficacy each year, causing 67% of them to stop treatment altogether.
Study Design
To unearth CF101’s effect, researchers assigned, in a blinded placebo-controlled period, 103 subjects to receive oral doses of CF101 1mg, CF101 2mg, or a matching placebo twice daily. After an analysis at 12 weeks, the CF101 group was deemed futile and was discontinued.
During a second study phase, investigators divided 223 additional patients between a CF101 mg oral daily group and a placebo group for 16 weeks. Subsequently, in an open label expansion period, researchers continued the CF101 participants with that therapy, but switched the placebo group to CF101 2mg for the study remainder, as well.
Safety and efficacy were examined at 4, 8, 12, 16, 20, 24, and 28 weeks. Final assessments were made at 32 weeks.
Of the initial participant group, 260 individuals (88.7%) completed the study, 125 were in the CF101 group (86.2%) and 135 received placebo treatment (91.2). Those who wither did so because of lack of efficacy, unacceptable concomitant medication or therapy, investigator decision for the patient’s best interest, non-compliance, and lost to follow-up.
Safety & Efficacy
To determine whether CF101 is safe and effective, investigators created two endpoints. First, they analyzed the number of subjects that achieved PASI 75 at 12 weeks, and, second, they looked at the number of subjects that reached PASI 75 at week 16. They also analyzed the number that achieved PGA of 0 or 1 at 12 and 16 weeks.
The first endpoints weren’t met, but between weeks 16 and 32, CF101 participants demonstrated PASI 50, 75, 90, and 100 rates of 63.5%, 35.5%, 24.7%, and 10.4%, respectively.
Figuring out the drug’s safety was also paramount. To do so, investigators examined treatment emergent-adverse events and changes in vital signs, physical examinations, clinical laboratory tests (liver, kidney, hematology, chemistry, urinalysis, and pregnancy tests), and ECG findings.
According to results data from the primary endpoint, the treatment groups showed no statistically-significant difference at week 12. Of the CF101 2mg group, only 12 of 141 participants (8.5%) achieved PASI 75 at week 12. In the placebo group, it was 10 out of 144 (6.9%).
The second endpoint also showed no statistical significance at week 12. Nine out of 141 CF101 2mg subjects (6.4%) and 5 of 144 placebo subjects (3.5%) achieved PGA of 0 or 1 during this time.
Study data also revealed more positive results. At weeks 20 to 32, the CF101 group showed linear improvement in PASI 50 (63.5% of patients at week 32), PASI 75 (35.5%), PASI 90, (24.7%), and PASI 100 (10.6%). At week 32, PASI mean percent improvement was 57%.
Researchers also compared CF101 efficacy rates against apremilast global Phase 3 trial. Based on the comparison, CF101 efficacy rates continued to rise past 16 weeks of treatment. Apremilast levels plateaued at this point.
The data supports any benefits coming from CF101 because placebo responses are rare at PASI 90 and Psi 100. The number of participants achieving PGA of 1 or 2 with CF101 2mg was also significantly higher between weeks 24 and 32.
Treatment Emergent-Adverse Events
Some participants experienced at least one treatment emergent-adverse event. In the CF101 2mg group, 37 of 145 subjects (25.5%) experienced an adverse event, as did 29 of 148 placebo participants (19.6%). Overall, these negative events occurred evenly across the studies.
In the blinded placebo-controlled period phase, for the CF101 group, infections and infestations were most common – 10 of 145 participants (6.9%) experienced one. In the placebo group, 13 of 148 (8.8%) did. Gastrointestinal disorders, including abdominal pain, diarrhea, dry mouth, and nausea were also common. Eight CF101 participants (5.5%) experienced them, and 3 placebo participants (2%) did.
Infections and infestations were also the most common negative events for the CF101 open label expansion group, affecting 23 of 275 participants (8.4%).
The remainder – and majority – of treatment emergent-adverse events that occurred were mild and determined to be unrelated to CF101. Severe adverse effects did happen, although they were also unrelated to the drug. Four participants experienced a severe problem, and one participant died.
Apremilast vs CF101
| Characteristic | Apremilast | CF101 |
| Brand Name | Otezla | Piclidenoson |
| Conditions Treated | Psoriasis; Psoriatic Arthritis | Psoriasis; Psoriatic Arthritis; Rheumatoid Arthritis |
| Administration | Oral | Oral |
| Adverse Impacts | Diarrhea; Nausea; Upper Respiratory Infection; Tension headache; Headache | Diarrhea; Nausea; Kidney disorders; Nervous system disorders; Musculoskeletal disorders |
| Impact | Anti-inflammatory effect | Anti-inflammatory effect
|
| Function | Small-molecule inhibitor for phosphodiesterase 4 | Adenosine receptor inhibiting tumor necrosis factor-⍺, interleukin-6 and -12, macrophage inflammatory proteins, and receptor activator for NF-KB ligand |
| Avoid | Pregnancy; Breastfeeding | Pregnancy; Breastfeeding |
To read the article at its original location: http://www.rheumatologynetwork.com/psoriatic-arthritis/apremilast-vs-cf101-psoriasis
Radiology’s Role in Integrated Health Care Systems
Published on the Nov. 16, 2016, DiagnosticImaging.com website
By Whitney L. Jackson
For most of you, diving into radiology practice meant joining an academic department, launching a private venture, or signing on with a teleradiology company. Those three practice models consume the lion’s share of all radiologists reading studies today.
However, another model exists – the integrated health care delivery approach most widely touted by Kaiser Permanente. Through this multi-physician, multi-specialty design, Kaiser Permanente offers health care services, including radiology, through networks of medical centers.
It’s a system that places significant weight on preventive care and positive patient outcomes. To meet that goal, said Bruce Wollman, MD, associate medical director for the Mid-Atlantic Permanente Medical Group, all providers, including radiologists, proactively work together with radiology playing a big role.
“Radiology is the center of the medical universe. In a system, like Kaiser, in which patient care is first and foremost, radiology has a very prominent voice,” he said. “But, Kaiser is a big group. We’re not just a big radiology practice, but thousands of doctors of all specialties all working together on the same team.”
And, just as the system design is a little different, so are the reimbursement and referral models.
Reimbursement
In private, academic, and teleradiology practice, the overarching reimbursement model is still fee-for-service in which you are paid for the number of studies you read. Kaiser’s integrated health delivery model is different, Wollman said. Instead of being paid per scan, Kaiser physicians are salaried. Just like surgeons aren’t paid for the number of operations they perform, and radiologists’ salaries are not based purely on the number of studies they interpret.
The outcome, he said, is optimized patient care.
“There’s no financial incentive for us to recommend additional imaging or surgeries or other things,” he said. “The financial incentive of the organization is to keep our patients healthy, so there’s no need for us to do things just for the sake of additional billing.”
To read the remainder of the article at its original location: http://www.diagnosticimaging.com/practice-management/radiologys-role-integrated-health-care-systems
Infections and Biologics in Rheumatoid Arthritis
Published on the Nov. 11, 2016, Rheumatology Network website
By Whitney L. Jackson
Biologics might have revolutionized treatment for rheumatoid arthritis, but existing research also points out that using these medications can increase the risk of serious infections or hospitalizations in some patients.
According to registry and observational studies, risk levels for infection are highest during the first six months of tumor necrosis factor inhibitor biologics treatment with a plateau hitting between 24-to-36 months.
A new study published in Current Rheumatology Reports reviewed key studies into these rheumatoid arthritis-related negative incidents, finding risk is greater with tumor necrosis factor inhibitor biologics than with traditional disease-modifying anti-rheumatic drugs.
To highlight this difference in risk, researchers discussed several existing studies that address individual questions of how biologic treatments affect rheumatoid arthritis in an attempt to help clinicians and patients make the most informed decisions about therapies.
Biologics Use
The biologics, which inhibit key cytokines and cytokine pathways, most often used to treat rheumatoid arthritis are etanercept, infliximab, golimumab, certolizumab pegal, adalimumab, anakinra, tocilizumab, abatacept, and rituximab. Despite their benefits, patients and providers worry both about injection site reactions, as well as infections.
Role of Disease in Risk
According to one study, it’s the altered immune system response present with rheumatoid arthritis that increases the infection risk. These patients have a greater chance of failing traditional disease-modifying anti-rheumatic drugs, making them candidates for biologics. However, if a patient has active rheumatoid arthritis, as well as a serious infection, it’s difficult to identify whether biologics are truly responsible for the infection.
Comparing biologics patients with those receiving other treatments, such as methotrexate, can help providers and patients better understand the risk. This data comes from observational studies, but it’s limited by confounding bias, channeling bias, differential follow-up, detection bias, and follow-up loss.
Rheumatoid Arthritis Role in Infections
Overall, rheumatoid arthritis patients have a higher ratio for developing infections than patients that don’t have rheumatoid arthritis.
A study of 609 rheumatoid arthritis patients and 609 non-rheumatoid arthritis patients, all over age 18, revealed rheumatoid arthritis patients have higher rates in 11 infection categories (95% CI, 1.41 to 1.65). Only two categories – urosepsis/pyelonephritis and gastroenteritis – didn’t pose a higher risk level.
Hospitalized Infection Risk
Rheumatoid arthritis patients have a two-fold increased adjusted risk of hospitalized infections when compared to those without rheumatoid arthritis. A retrospective cohort study performed with 1999-2006 claims data revealed the risk of hospitalized infections with a rate ratio of 1.88 (95% CI 1.71 to 2.07).
Rheumatoid Arthritis and Hospitalized Infections
Higher disease activity in rheumatoid arthritis patients does correlate to an increased rate of hospitalized infections.
Based on data from the Consortium of Rheumatology Researchers of North America, culling data from 16,242 patients, researchers identified 2,282 infections during 7,290 patient-years of follow-up. Of those incidents, 59 became hospitalized infections.
Every 0.6 increase in the disease activity score 28 used to assess clinical disease activity was associated with a 25% increased rate of infections that led to hospitalizations. These results, researchers said, indicate that controlling rheumatoid arthritis disease activity as best as possible could not only improve function and quality of life, but it could also lower infection risk rates.
Biologics and DMARD Differences
Patients using tumor necrosis factor inhibitor biologics do experience a greater infection risk during their first six months of treatment (95% CI 1.3 to 2.6). According to researchers, the risk is higher compared to traditional disease-modifying anti-rheumatic drugs by 1.2 to 1.8 times for up to 24 months following the beginning of biologics therapy (95% CI 0.6 to 1.3).
Using data from the British Society for Rheumatology Biologics Register, investigators compared serious infections between 11,798 biologics-treated patients and 3,598 disease-modifying anti-rheumatic drugs. Of those patients 1,808 developed at least one serious infection with incidence rates of 42/1,000 patient years of follow-up with biologics (95% CI 40 to 44) and 32/1,000 patient years of follow-up with disease-modifying anti-rheumatic drugs (95% CI 1.1 to 1.5).
Serious infection risk rates didn’t differ much for the three biologics examined – adalimumab, etanercept, and infliximab.
Do Biologics Differ?
For those using biologics therapy, serious infections are defined as ones needing hospitalization, intravenous antibiotic therapy, life-threatening, or ones that lead to significant disability. However, biologic therapies aren’t all the same when facing these negative events, such as pneumonia and cellulitis.
In a study using data from the Dutch Rheumatoid Arthritis Monitoring registry, researchers discovered the adjusted risk of serious infections was significantly lower with etanercept than with infliximab (HR=0.49, 95% CI 0.29 to 0.83) or with adalimumab (HR=0.55, 95% CI 0.44 to 0.67). Among this group, lower respiratory infections were the most common.
A study examining serious infections in the first 12 months of biologic and disease-modifying anti-rheumatic drug therapy supported those findings. Among rheumatoid arthritis patients, infliximab was linked to a significant increase in serious infections compared to etanercept (HR=1.26, CI 95% 1.07 to 1.45) and adalimumab (HR=1.23, 95% CI 1.02 to 1.48). Based on these results, glucocorticoid use was associated with dose-dependent infection increases.
In addition, a study of 11,466 patients with psoriasis or psoriatic arthritis examined serious infection risks with four biologics: infliximab, adalimumab, ustekinumab, and etanercept. The cumulative incidence rate was 1.45 per 100 patient years (323 serious infections), and the respective rates were 0.83, 1.47, 1.97, and 2.49 per 100 patient years for ustekinumab, etanercept, adalimumab, and infliximab, respectively. By comparison, rates for non-methotrexate/non-biologics were 1.05 and 1.28 per 100 patient years for methotrexate/non-biologics.
Biologics and Hospitalized Infection Risk
Overall, research shows using biologics increases the risk of hospitalized infections compared to traditional disease-modifying anti-rheumatic drugs. However, there are no studies directly comparing biologics and corticosteroids.
Biologics Risk Increase as a Group
In a group of rheumatoid arthritis patients, pneumonia and urinary tract infections were the most common infections. Study data showed current biologic use was linked with significantly higher hospitalized infection risks (relative risk 1.21; 95% CI 1.02 to 1.43). Methotrexate and hydroxychloroquine use were associated with lower risk – 0.81 (95% CI 0.70 to 0.93) and 0.74 (95% CI 0.62 to 0.89), respectively.
Biologics Differences and Hospitalized Infection Risks
When compared, adjusted hospitalized infection rates for etanercept, adalimumab, abatacept, and rituximab were similar. However, the rate was increased for infliximab (HR 2.3, 95% CI 1.3 to 4.0).
According to study data, hospitalization risks were greater with older patients and those with chronic obstructive pulmonary disease. Prednisone doses of >7.5 mg/day and chronic inflammation were also linked to an increased hospitalized infection risk.
Biologics, Hospitalized Infections, and Concomitant Use
Based on existing research, the verdict is still out on whether concomitant use of biologics is effective. In a study comparing denosumab and zoledronic acid, investigators found the rate of hospitalized infections was comparable (HR=0.89, 95% CI 0.69 to 1.15).
Although the study demonstrates concomitant use of denosumab might be safe, these results cannot be generalized to other concomitant biologic use for rheumatoid arthritis treatment. In fact, other studies show concomitant biologics use in rheumatoid arthritis patients increases infection rates without improving efficacy.
Infection Risk and Switching Biologics
When assessing the risk of hospitalized infections for rheumatoid arthritis patients, the overall crude incidence rate was 15.3 per 100 patient years (95% CI 14.7 to 15.9), ranging from 13.1 per 100 patient years for abatacept to 18.7 per 100 patient years for rituximab. The results also showed that infection risks were greater for infliximab and etanercept than they were for abatacept.
Another study looking at switched biologic therapy for rheumatoid arthritis patients determined the hazard rate for all infections was significantly higher for adalimumab, etanercept, and infliximab. Rates were not higher for abatacept. When compared to rituximab, severe infection risk was significantly higher for infliximab, but not for abatacept, adalimumab, or etanercept.
To read the article at its original location: http://www.rheumatologynetwork.com/rheumatoid-arthritis/infections-and-biologics-rheumatoid-arthritis
Who am I?
I’m a seasoned reporter, writer, freelancer and public relations specialist with a master’s degree in international print journalism from The American University in Washington, D.C.
I launched my journalism career as a stringer for UPI on Sept. 11, 2001, on Capitol Hill. That day led to a two-year stint as a daily political reporter in Montgomery County, Md. As a staff writer for the Association of American Medical Colleges, a public relations specialist for the Duke University Medical Center and the public relations director for the UNC-Chapel Hill School of Nursing, I’ve earned in-depth experience in covering health care, including academic medicine, health care reform, women’s health, pediatrics, radiology, and Medicare.
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