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FOCUS TOPICS NEUROLOGY • HIT • PRECISION MEDICINE • ORTHOPEDICS • REHABILITATION

July/August 2020 >> $5

He Feels Their Pain, Then Repairs Their Injuries

Dr. Anthony Mascioli treats athletes at Campbell Clinic Since his days as a high school running back and basketball player, Anthony Mascioli, MD, has remained a serious sports fan.

Story on page 3

Dry Needling: An Alternative in the Hands of Seasoned Professionals

Technique is decades old but trending in Tennessee Dry needling has been utilized by physical therapists in Tennessee since 2011.

Article on page 4

AMA Issues New Privacy Principles

Organization Looks to Restore Trust, Power to Patients From wearables and fitness apps to EHRs and patient portals, an individual’s health data resides in a lot of different places.

Article on page 7

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All of Us Looks to Improve Care for Each of Us NIH Precision Medicine Project is Changing the Research Landscape By CINDY SANDERS

Historically, medicine has been a ‘one size fits all’ proposition. It’s only been in the last few decades, as researchers have begun to uncover specific mutations and mechanisms driving disease, that the concept of precision medicine has really begun to take root and flourish. While the field is still in its infancy, a bold initiative from the National Institutes of Health – the All of Us Research Program – is working to move the science forward dramatically. “Our goal is to improve health and medical breakthroughs for everyone,” stated All of Us CEO Joshua Denny, MD, MS.

The ambitious initiative looks to enroll one million individuals in the United States across the full spectrum of age, gender identity, race, ethnicity, sexual orientation, socioeconomic status, education, geography, health status and other factors influencing health. Denny noted many segments of the population have been underrepresented or left out of research projects in the past. “We specifically said we wanted this population to be reflective of the diversity of the United States,” he explained. By capturing this huge amount of deidentified data, the hope PHOTO CREDIT: NATIONAL INSTITUTES OF HEALTH.

ON ROUNDS

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Pioneering the Future: Orthopaedic Advancements in a Changing Field Laura Whitsitt, M.S., SVP, Research & Development- Orthopaedics, Smith+Nephew, Inc. By JUDY OTTO

During more than 30 years with global medical technology leader Smith+Nephew, (S+N) Inc., Senior Vice President of Research & Development-Orthopaedics Laura Whitsitt has seen a lot of history, and made some of it – as reflected, in part, by some of the patents S+N has acquired on her watch: for an artificial spinal disc, an artificial bone graft implant, bone fixation apparatuses, and more. Recognized as an Outstanding Alumna of the University of Memphis Herff College of Engineering, where she acquired her undergraduate and M.S. degrees, Whitsitt continues to serve her alma mater as a member of the College of Engineering Advisory Council, and her community as a member of the FedEx (CONTINUED ON PAGE 6)

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PhysicianSpotlight

He Feels Their Pain, Then Repairs Their Injuries Dr. Anthony Mascioli treats athletes at Campbell Clinic By LAWRENCE BUSER

Since his days as a high school running back and basketball player, Anthony Mascioli, MD, has remained a serious sports fan. He admires the skills and drive of talented athletes, but not just for what they do in competition. He has found that they can be pretty impressive when they’re hurt, too. “Athletes are excellent patients,” said Mascioli, an orthopedic surgeon at Campbell Clinic who specializes in sports medicine. “Their determination to get well is at a really high level because they really want to get back to practicing on the field. They want to rehabilitate and do what they have to do, so their motivation is pretty high. They are very determined.” He and four colleagues at the clinic share duties as the team physicians for the University of Memphis, the Memphis Grizzlies and Christian Brothers High School. They share on-call duties attending games, road trips and even practices so injured athletes can get immediate attention. “The most common injuries we see are cartilage tears, ACL tears, rotator cuff injury, shoulder dislocations, and your run-of-the-mill sprains and strains that do better with conservative treatment,” Mascioli said. “The most difficult are knee dislocations where you have to reconstruct multiple ligaments where there’s been severe trauma to the knee. “With the vast majority of injuries we treat, we want them back to 100 percent, and we set that goal for them. Most of them pretty much achieve that.” Mascioli joined Campbell Clinic in 2008 after a five-year residency there. Since then there have been major changes not only in how orthopedic surgery is per-

formed, but also where that surgery is performed. “The biggest change I’ve seen is the transition of major surgeries from the hospitals to our outpatient Surgery Center setting,” he said, referring to the clinic’s two facilities on Wolf River Boulevard in Germantown and on South Pauline in Midtown. “We’ve been able to transition the vast majority of cases traditionally done in a hospital setting to our surgery centers. “In 2013 my partner Dr. Patrick Toy did the first Surgery Center total hip replacement with a same-day discharge. In 2014, I did the first outpatient total knee replacement in our Surgery Center. We were way ahead of the curve on that and Campbell Clinic was one of the first in the world to do that.” He said the advantage of perform-

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ing surgery at their own facility can be summed up in one word: control. “I’ve talked all over the country about this and I think the biggest advantage is that at our Surgery Center we control everything,” Mascioli said. “I would not say that hospitals are bad places. They are great places to go, but at our Surgery Center we control everything from our employees to what equipment we use to the actual setting and I think that results in a really good experience and good outcome for the patient. “Since we started, we’ve amassed one of the biggest caseloads in the world from which we are presenting and publishing our results. We’ve done close to 2,000 outpatient total joint replacements. I typically do 300 or 400 cases a year.” He said that while his focus is more on sports medicine, Campbell Clinic sees patients from all walks of life, from children to elderly adults, with back pain, strains, arthritis and worse. Mascioli’s path to sports medicine began in high school in Rochester, N.Y., although he may not have realized it at the time. He suffered an ACL tear in his senior year football season, but it did not require surgery. His interest in healthcare as a career stemmed from his father, a podiatrist, and his mother, a nurse. “As soon as I got to college, I knew what I wanted to do,” said Mascioli, who attended State University of New York at Albany. “I applied myself and fortunately it all worked out.” After graduation in 2003 from State University of New York Downstate College of Medicine in Brooklyn, it was on to Memphis. “My father told me to interview at Campbell Clinic because it’s internationally known for teaching and research, the

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quality of physicians and the way they conduct business,” Mascioli said. “I was in orthopedic surgery as a five-year residency and at the end of the residency I decided to focus on sports medicine. “We have some really good sports guys at Campbell Clinic who were mentors and I saw that they were happy with what they do and were gratified with their professional careers. They’re good gentlemen and good physicians and I wanted to emulate them.” He also likes the challenge of repairing sports-related orthopedic injuries. “I enjoy the type of surgery because most of the time with sports injuries it’s done arthroscopically so you’re doing minimally invasive surgery with a scope,” he said. “It’s also technically demanding, and I enjoy doing that type of surgery. “We’ve seen a number of knee dislocations where literally the patient tears multiple ligaments in the knee, which requires very complex surgery. Sometimes these players will have bad fractures of the tibia or the shoulder in which case we will ask our trauma partners to help us out. Shoulder dislocations can be very difficult. There’s a myriad of injuries that can be difficult to manage. I think at this point I’ve seen pretty much everything. I did staff trauma at The Med for a couple of years so I got to see a lot of things that most people will never see.” Less challenging was the transition from being a native New Yorker to being a Mid Southerner. He says Memphis is a great place for him and wife Ellie to raise their two sons, Anthony, 10, and Bo, 8. There’s also plenty of duck hunting, fishing, golf and friendly people. “I love the people in Memphis,” said Mascioli. “I wouldn’t live any other place.”

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Dry Needling: An Alternative in the Hands of Seasoned Professionals

Technique is decades old but trending in Tennessee By JIM HAMBRICK

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Dry needling has been utilized by physical therapists in Tennessee since 2011. In Tennessee, physical therapists are required to have completed a minimum of 24 hours of CEUs and treat only the muscles specifically trained in each course. Many continuing education courses are designed in an upper and lower extremity progression. Course complexity also advances with head, neck and torso muscles. Most courses track progress with a certification denoting proficiency in all muscles and clinical reasoning for treating trigger points. Courses use existing research and musculoskeletal anatomy in relation to nearby tissues and systems to ensure the safety of the patient. Dry needling is most commonly used to treat myofascial trigger points. According to Dr. Janet Travell, MD, who gave this definition in the 1950s - trigger points are “areas of hyper irritable spots in the skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band. The spot is tender when pressed and can give rise to characteristic referred pain, motor dysfunction, and autonomic phenomena.” Dry needling was first coined by Karl Lewitt, a Czech physician, in 1979. Lewitt emphasized the benefits of the needle in comparison to the injection of substances… wet” needling. Most all of us are harboring trigger points. A common site most can relate to are the “knots” or hard spots up on top of our shoulder blade/neck area. This would be in the Trapezius or Levator Scapulae muscle. These are the muscles someone is common to want to press on or rub to relieve tension and associated pain or tenderness. The contractile components in the muscle cell have not released and thus the muscle is remaining in a constant state of contraction. This contraction then develops an area of hypoxia and increase in nociceptive agents in the tissues. The needles used in dry needling are the same as the needles used in acupuncture. They come in varying gauges and lengths. Trigger point depth and patient sensitivity should be among the decisions on size type of needle used. Most patients experience little or no discomfort with the needle insertion. Patients are usually placed in a supine or prone position for the delivery of dry needling. The therapist is able to isolate the focal point of the trigger point by palpating across or perpendicular to the muscle fiber orientation to find a taut band, and then along that taut band to the spot of

greatest muscle tone and generally patient tenderness. The needle is then inserted, moved to the trigger point and a local twitch response, or involuntary jump of the muscle, is desired to eliminate that trigger point. There can be multiples of twitch responses within a given muscle. This trigger point elimination should result in a decrease in involuntary tone of the muscle and decrease in local and referred pain should be lessened. Decreased pain with active movement is often an immediate benefit the patient appreciates. Post treatment soreness is common with the twitch response. This soreness can last from hours to a couple of days. Conditions treated using dry needling are referred pain in an extremity with or without radiculopathy, painful joint movement with or without advanced degenerative changes, as well as headaches from muscle tension. When muscle tension is the trigger for migraine headaches, management of the migraine patient can often benefit from dry needling. Trigger points, or involuntary muscle tension can alter joint mechanics. This alteration can lead to painful joint mobility and an increase in joint articular compressive forces. Elimination of trigger points can allow for more normal joint mechanics and improved range of motion. Treatments should then be followed with physical therapy for proper flexibility and strengthening regimens. These treatments may involve passive joint and muscle stretching and home exercises. Postural awareness and corrective postural exercises, neuromuscular movement re-education also can enhance the long-term elimination of trigger points. Jim Hambrick has been a physical therapist for 32 years. He has been co-owner of Rehab Etc for 27 years. Rehab Etc operates Physical Therapy clinics in Memphis, Bartlett, Collierville, Oakland and Nashville Tennessee.

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The Impact of Diabetes on Stroke Research Points to Worsened Brain Function, Increased Severity By CINDY SANDERS

Diabetes is well established as a risk factor for stroke. For diabetics, the chance of having a stroke is 1.5 times higher than in people who do not have the condition, according to the American Diabetes Association. However, the burden of diabetes is likely even higher. Recent studies find diabetes might impact post-stroke outcomes, as well.

Increased Risk

Jorge Plutzky, MD, chair of the Diabetes Committee of the American Heart Association, said the systemic disease of diabetes accelerates atherosclerosis, increases risk for atrial fibrillation and is often accompanied by high blood pressure. All three of those conditions can lead to heart Dr. Jorge Plutzky attack and stroke. “We’ve always known we need to pay attention to people who have had a heart attack or stroke for another one,” Plutzky said. “People who had a history of diabetes but no heart attack had the same risk as someone who had previously survived a heart attack,” he continued, adding the same is true for stroke. Plutzky, who is also director of preventive cardiology at Brigham and Women’s Hospital and on faculty at Harvard Medical School, said diabetes intersects with stroke risks at several points – from the link between type 2 diabetes and obesity, which is often accompanied by high blood pressure and high cholesterol, to peripheral artery disease and microvascular disease, which have been linked to dementia and Alzheimer’s. Less clear is the role of prediabetes as a risk factor for stroke and heart attack. “The absence of association between prediabetes and stroke does not inform us of the relationship of diabetes and stroke,” said Plutzky. “The complexity of the disease means it can be difficult to draw a circle around prediabetes – how you are defining it,” he pointed out. “We know that people with prediabetes do have a higher risk for diabetes, but not all will go on to diabetes.” However, he cautioned, it doesn’t mean someone with prediabetes won’t have a stroke. Nor does it mean those with prediabeties can bank on being in the group that doesn’t develop diabetes.

Cognitive Function

In May, the American Heart Association published a new analysis of seven memphismedicalnews

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international studies looking at post-stroke progress three to six months after the event. The analysis found study participants with diabetes functioned worse than those without on measures for memory, attention, mental flexibility, processing speed, language and other tests of cognitive function. Looking at 1,600 stroke patients in Australia, France, Korea, the Netherlands, Singapore and the United States – almost all of whom had ischemic strokes – researchers also considered whether there was a difference in outcomes between those with type 2 diabetes and those classified as being prediabetic. It should be noted, the classification was determined by a single measurement of fasting blood sugar levels at hospital admission and medical history without follow-up measurements or additional information on severity or duration of disease. With that limitation, and after adjusting for age, gender and education, researchers found that diabetic stroke survivors had “significantly poorer” function than others, including those with prediabetes. Even after adjusting for additional factors including high blood pressure, smoking, body mass index, previous stroke history and ethnicity, the results held up with prediabetic stroke survivors not experiencing the severity of cognitive decline as seen in those with diabetes. According to the researchers, led by Perminder Sachdev, AM, MBBS, MD, PhD at UNSW Sydney, key takeaways include: A call to focus on early, more aggressive treatment for prediabetes to prevent the progression to type 2 diabetes; and The need to assess the capacity for self-care in diabetic stroke survivors to ensure patients have the ability to fulfill the complex tasks required to measure and manage diabetes.

Adding Alzheimer’s to the Equation

Diabetes has also been linked to an increased risk for vascular dementia and Alzheimer’s disease. A separate study released earlier this year found the combination of diabetes and Alzheimer’s disease compounded severity for those with hemorrhagic stroke. Analyzing more than 2,000 adults in the Kentucky Appalachian Stroke Registry, researchers found 75 percent with both diabetes and Alzheimer’s either died or required hospice or long-term care post-stroke compared to 62 percent with Alzheimer’s alone, 42 percent with diabetes alone, and 39 percent with neither (CONTINUED ON PAGE 6)

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Pioneering the Future: Orthopaedic Advancements, continued from page 1 Institute of Technology Advisory Board, the Memphis Research Consortium, and the Greater Memphis Chamber Board of Directors, among others. Her early aptitude and love for math and science – and two favorite teachers – guided her into engineering, but it was during a graduate internship at Smith+Nephew that her fascination with the medical aspect of engineering burgeoned. Her current role at S+N is trifold, encompassing RTI (Research, Technology, and Innovation), which assesses and evaluates the feasibility of early stage technologies; Product Development that addresses the needs of surgeons and patients; and continuing Product Support. Recently launched S+N technologies she and her colleagues have shepherded into the marketplace include the Real Intelligence brand of Smith+Nephew face masks in use in a clinical setting. enabling medical technology solutions throughout charitable boards, but doing corporate the continuum of care – and the CORI board work, as well. surgical system, a new generation handAnd while she justly values those proheld robotics platform with faster camera fessional accomplishments that have delivfunction and more efficient cutting techered innovative and unique orthopaedic nology, sized for ambulatory surgery cenproducts like OXINIUM to surgeons and ters (ASCs). A new total hip arthroplasty patients, possibly the successes closest to (THA) option, the OR3O Dual Mobilher heart involve her work in mentoring. ity System, also offers increased range “To me, helping others to begin or of movement and jump distance in an advance their careers is extremely imporimplant created from S+N’s proprietary tant. I’ve mentored a number of men OXINIUM™ oxidized zirconium alloy, and women within Smith+Nephew to with its superior wear- and corrosionhelp them better grow their careers or resistant characteristics. address challenges in their current roles, More than two million patients have and I also reach out to young women in already received hip and knee replaceenvironments where they may not have ment implants made from OXINIUM, knowledge or access to all their career and its unique properties and perforopportunities.” mance record are inspiring Whitsitt’s “We’re starting to see a lot more team to develop more products that utilize women in college programs – particularly the material. in biomedical engineering,” she notes with They’re also focusing on the panpleasure. demic-driven universal need for more In her 30 years, she’s also seen “a big data, more telehealth products, and more change in orthopaedics as the healthcare digital ways to utilize products. With many system overall has changed its focus – from treatments now being done remotely, she a focus on product ‘bells and whistles’ to explains, “any way that we can facilitate products that provide efficiency and value. remote pre- and post-operative care for I think the future is going to include a lot patients with our devices and equipment of data, and digital technologies are going will be welcomed. to be very important.” “Some of our programs are looking She points to the growing number of at a more digital focus for trauma devices orthopaedic procedures that are moving – allowing patient interaction,” she hints. to ambulatory surgical centers (ASCs). “— like using an app to help adjust an S+N surgical technology is consequently external fixation device stabilizing their designed to be compact and efficient. fracture.” “In order to be successful, ASC’s Her short-term goals, in fact, focus have to have very streamlined processes on continuing to develop such products, and products because they don’t have a and to improve the processes used to get lot of room or a lot of time; they have to those products into users’ hands more effibe very efficient in their turnover of the ciently. rooms.” Her long-term goals are broader and Aware of research concerning include not only continuing to serve her arthritis treatment alternatives to joint community by sharing her insights and replacements, Whitsitt notes that S&N is experience on a lengthy list of civic and 6

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3D printer-produced masks are a hit.

also working on products that address the disease earlier in the process, potentially helping to delay the need for a hip or knee replacement. How has the pandemic impacted S+N? “Our business has been hurt, as have other businesses that are focused on elective surgeries. But instead of layoffs, we’ve implemented unique programs to support employees dealing with family COVID issues,” she points out. “And we’ve been extremely productive working from home; it really hasn’t slowed our research efforts.” In fact, they’ve turned the COVID challenge into an opportunity to support Church Health: “While our 3D printers weren’t fully utilized during the surgery slow-down, we were able create a COVID Product Response (CPR) team – which is continuing to print 5,000 headbands

and 15,000 disposable face shields for Church Health to use in their clinic and in COVID testing,” she notes. “It’s been a rewarding effort!” Balancing the many demands on her time has guided her to “be present in the moment and make sure I don’t neglect the very important things – family, work, community involvement, church, etc.” With three children and four grandbabies to enjoy, she still makes time for summer weekends at a lake house in Lexington, supporting her husband’s not-for-profit home renovation business that trains refugees and immigrants for construction careers, and for remodeling a 1940’s-vintage abandoned home for their own use. To our readers – and those she mentors – Whitsitt offers advice: “Find a career that you can be truly passionate about – and share your experience generously to guide those who follow, so they can benefit from your successes – and mistakes!”

The Impact of Diabetes, continued from page 5 condition. Researchers did not have each patient’s specific blood pressure measurement at the time of stroke … but if high blood pressure, a common cause of hemorrhagic stroke, had been previously diagnosed, the research team did control for that factor. Even with that limitation, the study’s authors stressed the need to effectively manage diabetes in light of the significantly worse outcomes that accompanied diabetes and Alzheimer’s, particularly in combination.

Early Intervention

With prediabetes, Plutzky said it is essential to address lifestyle modifications to try to slow or halt the progression to diabetes. For those who already have diabetes, he said there has been a “sea change” in the management of the disease with the addition of two newer classes of therapies. Whereas older treatments didn’t reduce

the risk of heart attack and stroke, sodiumglucose co-transporter inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 agonists (GLP-1 receptor agonists) do. “We do want physicians to be aware of these newer drugs because they are underutilized,” he noted. “The presence of diabetes increases one’s risk for heart attack and stroke,” summed up Plutzky. “Not only does it increase the risk for having a stroke but for not doing as well after having a stroke, and it may be linked to cognitive function, in general.” However, he added, early intervention and improved management through both drug therapy and lifestyle modification can change the trajectory for a patient. “Paying attention to all the red flags – both in prediabetes and diabetes – can make a difference in how patient’s ultimately do,” Pltuzky concluded. memphismedicalnews

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AMA Issues New Privacy Principles Organization Looks to Restore Trust, Power to Patients By CINDY SANDERS

From wearables and fitness apps to EHRs and patient portals, an individual’s health data resides in a lot of different places. In the wake of rising privacy concerns, however, the American public has grown increasingly worried about how their information is used and with whom it is shared. In response to this unease, the American Medical Association released new privacy principles in May that support an individual’s right to control, access and delete personal data collected about them. Jesse Ehrenfeld, MD, MPH, immediate past chair of the AMA Board of Trustees, said it was important for the organization Jesse Ehrenfekd to take a leadership role on the topic. “Trust is a fundamental component of the physician-patient relationship. For me to provide the best care to my patients, my patients have to trust they can share information with me they might not want anyone to know,” he said, adding there’s only one opportunity to get it right. “Once privacy is lost, you can’t get it back. Privacy has to be fiercely protected.” Rock Health and Stanford Center for Digital Health recently released a

white paper outlining findings from the 2019 Consumer Adoption Survey. In its fifth year, the study highlighted another reason the AMA is well positioned to take the lead in outlining privacy expectations – physicians remain the most-trusted group when it comes to sharing health data. Even physicians, however, have seen consumer confidence slip a little over the last three years. Yet, nearly three-quarters of respondents still were willing to share information with physicians and more than half with insurance companies compared to 23 percent willing to share with health tech companies, 12 percent with the government, and only 10 percent with general tech companies. Confidence has been shaken by a number of tech sector breaches and scandals over the last few years, said Ehrenfeld, a public health policy expert who serves as director of the Advancing a Healthier Wisconsin Endowment. Additionally, there is growing recognition and frustration over the tech business model that quietly collects personal data, often without consumer knowledge or consent and without the strictures that accompany HIPAA. “We fully support the right of patients to be able to access, download and share their data,” Ehrenfeld stated, adding that control belongs with the individual not an entity. To address these concerns and issues, he said the AMA Privacy Principles out-

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Highlights of AMA Privacy Principles The American Medical Association detailed expectations and rights for data exchange and privacy derived primarily from policy approved by the AMA House of Delegates. In a release, AMA leadership said the goal is to create a national framework of transparency and guardrails to guide data collection, direct privacy legislation and build public trust. The privacy principles are available online at memphismedicalnews.com. Individual Rights: Recognition that individuals have the right to know who is collecting their data, why it’s being collected, how it will be used, and what is in the information. Furthermore, the AMA calls for individuals to have control over their info unless privacy rights have been waived “in a meaningful way,” the data has been appropriately de-identified, or in rare instances when a public health or safety issue warrant “limited invasions of privacy or breaches of confidentiality.” Equity: Commitment to adopting privacy protections promoting equity and justice to ensure individuals are safeguarded from discrimination, stigmatization, profiling or exploitation in the collection, processing or sharing of data. Entity Responsibility: Expectation that all entities that maintain an individual’s health information “should have an obligation or ‘duty of loyalty’ to the individual.” With that expectation, the entity should disclose exactly what data is collected and for what purpose. Applicability: Understanding that privacy legislation applies to all entities that “access, use, transmit and disclose data,” including entities not traditionally associated with healthcare that might be outside current HIPAA regulation. Enforcement: Recognition that individuals shouldn’t be responsible for the cost of enforcement except when exercising their private right of action. Furthermore, federal privacy legislation should serve as a “floor, not a ceiling” and shouldn’t weaken any state laws or regulations.

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All of Us Looks to Improve Care, continued from page 1

is to build one of the most comprehensive precision medicine platforms in the world, allowing researchers to speed discovery by tapping into a breadth and depth of information that is not currently available. Moreover, Denny said the goal is to make this rich dataset easily accessible. “We really Joshua Denny believe that the best science is done in a broad, open fashion,” he noted. Denny has been involved with the initiative from the very beginning. He was part of the NIH’s Precision Medicine Initiative Working Group while serving in his previous role as director of the Center for Precision Medicine and vice president for Personalized Medicine at Vanderbilt University Medical Center in Nashville. The work group released a detailed report in September 2015 that became the framework to create the All of Us research platform. At the end of last year, Denny was tapped to lead the NIH effort.

Engaged Participants

Participation was purposefully made easy. Anyone aged 18 or older who lives in the United States is eligible to become part of the large study by simply logging onto JoinAllofUs.org. Participants answer health surveys, share electronic health records and might be asked to provide key physical measurements and biospecimens of blood and urine. Some will also be asked to provide saliva for lab and DNA tests. Those asked to share biosamples are able to visit a convenient partner site. However, participants decide how much data they are willing to share. Those who opt not to share their EHR can still participate in health surveys but wouldn’t be included in other aspects of the program. Denny noted active engagement among participants sets the program apart. “We’re not a typical research study that just collects information and does research … we engage participants,” he said of actively seeking input and sharing information.

Advancing Research

At the heart of All of Us is the desire to move science forward in a safe, effective, efficient manner by building one of the world’s largest and most comprehensive databases. “It is really to drive medical care, treatment and prevention,” Denny said of the massive undertaking. “It is both about population research and precision medicine research.” He pointed to cystic fibrosis research that led to the 2013 debut of the first drug targeting a specific CF mutation. “It only worked in 5 percent of the population, but it was almost curative,” he said of the breakthrough. Building off that genetic knowledge led to further discovery. By 2019, novel treatments were available to improve function and quality of life for 90 percent of CF patients. 8

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From a population health standpoint, Denny said researchers discovered a small population of African-Americans in Dallas had a rare mutation that corelated with significantly lower cholesterol and was protective of heart disease. That discovery by geneticists at UT Southwestern ultimately led to a new class of drugs for lowering LDL cholesterol in the broad population. “Those two stories highlight the power of genomics and how data can impact specific populations and everyone,” Denny said. Having easy access to rich data allows researchers to move more quickly and with greater assurance, he said of the repository of millions of pieces of information All of Us will contain that can be easily sorted by population characteristics, disease characteristics, geography, age, exposures, medication regimens, genetic signatures and more. “You don’t have to recruit a new population of participants,” he pointed out. “Once you have a research database that’s large and has dense disease data and molecular information like genetics, it’s almost a look up.” Denny added the current COVID-19 pandemic underscores the need for this type of information that could provide scalable insights into who is protected and affected by the virus. “We’re trying to rethink the whole process of doing research,” he said, adding the goal is to allow broad access for both public and private researchers following beta testing, which launched at the end of May. Once researchers have registered and gone through the onboarding process, All of Us uses a ‘data passport’ model that provides wide access to explore data rather than having to be granted permission for each study on a project-by-project basis. As part of beta testing the All of Us Researcher Workbench, participating researchers have begun using the study’s initial dataset and tools and have been asked to provide feedback. “We really welcome any U.S. academic researcher at this beta phase,” Denny added. Go to ResearchAllofUs.org for more information on applying for access.

Increasing Enrollment

To date, All of Us has more than 349,00 individuals who have taken the first steps of enrolling. Of that group, over 271,000 have completed the initial stages of the program, which include completing the in-person visit for measurements and biospecimens, offering consent for EHR access, and finishing the initial surveys. Denny noted progress has been slowed over the past few months during shelter-in-place orders that accompanied COVID-19. He added genetic testing was slated to begin just as the pandemic hit. “We’ve actually paused our in-person recruiting right now,” he explained, adding the team is assessing safety and timing to restart visits to partner facilities. Despite that pause, Denny encouraged anyone interested in being part of this seminal study to begin the enrollment process now. In addition to providing important information online that could

be immediately useful, it also puts participants in a ready position when in-person visits start back. While Denny said it is crucial for physicians to share the importance of All of Us with patients to increase representative enrollment, he encouraged providers to become part of the cohort, as well. “The program is only as powerful as the participants who join us on this journey,” Denny concluded. “We want to make sure everyone is represented here at the table.”

AMA Issues New Privacy Principles, continued from page 7

line transparency expectations across five main categories – individual rights, equity, entity responsibility, applicability and enforcement. Ehrenfeld noted part of the impetus for AMA publishing these new principles stems from the spring release of final rules on data sharing and patient control from the U.S. Department of Health and Human Services in connection to the 21st Century Cures Act and the MyHealthEData initiative. “We advocated strongly and regularly to HHS to include controls in those final rules that would promote how apps use health data and how patients can prevent an app from using their information without consent,” he said. “Unfortunately, HHS didn’t take any action in that final rule to promote transparency.” Ehrenfeld added, “HIPAA is a law that predates almost all modern digital technology. HIPAA does not cover data that is created or managed by a patient or third party app.” Without appropriate privacy controls, he said health information collected by apps or wearable fitness trackers could be shared with an employer or added to a credit score. “Once health information goes out the door and goes to a broker, you have the perfect recipe for harmful profiling and discrimination,” he pointed out. Yet, he continued, data collection is both ubiquitous and important to optimizing care. Trackers and apps can improve activity levels, diet, hydration and disease management. Data collection can highlight risk factors, identify at-risk populations or help clarify symptoms and spread of an infectious disease like COVID-19. “The more assurances people have about how entities will use that data, the more willing society will be to use technologies – whether it’s telehealth or contact tracing,” he said. “We think that having guardrails and transparency is key to building trust and not inhibiting data exchange. We want to restore confidence in data privacy, and that’s what our principles are all about,” Ehrenfeld concluded.

GrandRounds UTHSC Launches Elective Course in Telemedicine Due to the increased attention focused on telemedicine during the coronavirus pandemic, experts at the University of Tennessee Health Science Center are collaborating to offer a new elective course to medical students. Launched last month, the six-credithour course trains medical students in the clinical practice of telemedicine, technology, policies, benefits, and drawbacks. Sajeesh Kumar, PhD, associate professor in the Department of Diagnos- Sajeesh Kumar tics and Health Sciences in the College of Health Professions in Memphis, and John S. White, II, MD, assistant professor of family medicine in the College of Medicine in Jackson, Tennessee, co- John S. White, II direct the course. The practice of telemedicine, or the use of technology to evaluate and treat patients who are at a location separate from their health care provider, has increased substantially since the onset of the coronavirus pandemic. Students will learn and be trained on synchronous and asynchronous telemedicine platforms. Synchronous platforms are live, audio/visual communication that allow direct communication with the patient in real time, such as Zoom, Google Hangouts, Dox.me, and Doximity. Asynchronous platforms do not take place in real time. Examples of this include email and patient portal interactions. Training will also include clinical specialty practices, such as telepsychiatry, telepediatrics and real-time interaction with telehealth providers and patients in a remote clinical setting.

Challenge yourself. Challenge your friends. CHALLENGE CANCER West Cancer Foundation is committed to ensuring that women without insurance have access to potentially lifesaving mammograms, that cancer patients who need to get to treatment have transportation, and that innovative cancer research that could be the next breakthrough is funded. All of this is only possible with your support. Join West Cancer Foundation as we CHALLENGE CANCER. Our signature fundraising event may look a little bit different this year, but our mission remains the same: to FIGHT ON in the face of cancer! To support the cause and take the challenge: • Register for CHALLENGE CANCER • Participate in fun fitness challenges (https://raceroster.com/events/2020 /29908/challenge-cancer) • Raise funds for West Cancer Foundation • Tune in on September 12 for our virtual celebration memphismedicalnews

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GrandRounds Wright Medical Group Announces First Shoulder Arthroplasty Procedure Using BLUEPRINT™ Mixed Reality Technology Wright Medical Group N.V. (NASDAQ: WMGI), with U.S. Corporate headquarters in Memphis, has announced that the first shoulder arthroplasty procedure was performed using groundbreaking BLUEPRINT Mixed Reality Technology at Mayo Clinic’s campus in Rochester, Minnesota. Joaquin Sanchez-Sotelo, MD, PhD performed the procedure utilizing BLUEPRINT OR Visualization Mixed Reality software, which provides a 3-D holographic view of the patient’s pre-operative plan. Robert Palmisano, president and chief executive officer of Wright, said that the procedure is an important milestone for shoulder arthroplasty and marks a major step in the evolution of BLUEPRINT mixed reality technology in shoulder surgery. For the first time in shoulder arthroplasty, surgeons will be able to interact with their 3-D preop plan in real-time to more precisely tailor shoulder joint replacement procedures to the unique needs and anatomy of their patients. By integrating other solutions in the future, such as artificial intelligence, case planning optimization and mixed reality modules for medical education, the BLUEPRINT ecosystem offers an opportunity to significantly reduce variability in the way shoulder arthroplasties are performed, potentially reducing complications and improving overall patient outcomes. The Mixed Reality Application is the latest addition to Wright’s BLUEPRINT ecosystem and enables a surgeon to maintain a direct view of the surgical site and simultaneously visualize and manipulate a holographic representation of the patient’s native anatomy and pre-operative plan. By using hand gestures and voice commands, the surgeon can interact with a more robust data set to optimize the position of the 3-D holographic models displayed by the Mixed Reality application.

Two From UTHSC Receive President’s Awards Two outstanding leaders at the University of Tennessee Health Science Center were among the six winners of the 2020 UT President’s Awards announced today by UT President Randy Boyd. Michael Alston, EdD, CCDP/AP, chief diversity officer, assistant vice chancellor for Equity and Diversity, and Title IX coordinator at UTHSC, and Robert Williams, PhD, UT-Oak Ridge National Laboratory Governor’s Chair in Computational Genomics and Michael Alston chair of the Department of Genetics, Genomics and Informatics, were selected for the annual awards, which represent the highest honor a UT memphismedicalnews

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The Next Generation of

employee can receive from the university. The awards are presented in different categories which include Educate, Discover, Connect, Support Exempt, Support Nonexempt, and Robert Williams Diversity. Dr. Williams was honored in the Discover category and Dr. Alston was honored in the Diversity category. Honorees are selected from across the system from nominations by campus and institute leaders. Dr. Alston holds a doctoral degree from Peabody College at Vanderbilt University and a professional diversity management certificate from the School of Industrial and Labor Relations at Cornell University. He is from Brighton, Tennessee and a 1984 graduate of Munford High School. Dr. Williams received his PhD in physiology from the University of California, Davis, and completed postdoctoral work in developmental neurobiology at Yale School of Medicine. He joined UTHSC in 1989 in the College of Medicine’s Department of Anatomy and Neurobiology. In 2013, he became the founding chair of the Department of Genetics, Genomics and Informatics at UTHSC. Dr. Williams was one of the lead scientists behind the creation of the Tennessee Mouse Genome Consortium, which developed mouse models for use in studying gene function in humans primarily related to aging, blinding diseases, addiction, and neurological disease.

Hassan Aziz Named President-Elect of American Society of Clinical Laboratory Science Hassan Aziz, PhD, FACSs, MLS(ASCP) cm, executive associate dean for Academic, Faculty and Student Affairs and interim chair of the Department of Diagnostic and Health Sciences in the College of Health Professions at the University of Tennessee Health Science Hassan Aziz Center, has been named president-elect of the American Society of Clinical Laboratory Science. Dr. Aziz will hold the position for a year before assuming full presidency. The American Society of Clinical Laboratory Science provides advocacy, standards setting, education, personal and professional development for clinical laboratory science practitioners. As president-elect, Dr. Aziz will assist the organization’s current president as directed and preside at meetings of the board of directors in their absence or if the office is vacated. He will also serve as a member on the Executive Committee, chair the Committee on Long Range Planning and the Appointments Committee, and serve on the Annual Meeting Steering Committee or other committees as assigned.

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GrandRounds Cato Johnson Appointed to Tennessee Historical Commission Methodist Le Bonheur Healthcare’s Senior Vice President and Chief of Staff, Cato Johnson, will serve a five-year term with the Tennessee Historical Commission. Appointed by Governor Bill Lee earlier this month, Johnson will represent West Cato Johnson Tennessee and, along with the 24-member commission, will make recommendations on how best to preserve and honor Tennessee history. Johnson, who actively serves as chair for the State’s TennCare Advisory Committee, most recently served on the Governor’s Healthcare Working Group to establish best practices for reopening the state-wide and local economies. In June, Johnson was named to the statewide COVID-19 Child Wellbeing Task Force, which works to ensure the needs of Tennessee children are met during and after extended periods away from school. With this new appointment to the TN Historical Commission, John-

son is eager to honor the individuals who stand for equality and justice, and whose legacies aim to unite Tennesseans.

AMA: Physicians Can Opt-out from 2020 MIPS Program CMS announced that physicians will have the option to opt-out completely or partially from the 2020 MIPS program by completing a hardship exemption application and indicating it is due to the COVID-19 Public Health Emergency (PHE). Individual clinicians and group practices have until December 31, 2020 to complete the hardship application. CMS plans on providing physicians with a couple of options on the hardship exemption application. For example, a practice may submit a hardship application and indicate that they do not want to be scored on Cost and Quality and have their score calculated based on just Promoting Interoperability and Improvement Activities. Alternatively, practices may submit a hardship application and opt-out of all four performance categories and be held harmless from a 2022 payment adjustment.

Submitting any MIPS data to CMS will override the hardship exception application and physicians will be scored on their submission. The American Medical Association (AMA) is pleased CMS took our recommendation to create flexible reporting options in 2020 with the option to reweight any or all of the MIPS performance categories. The flexibilities should assist with allowing practices to focus their attention on caring for patients during the pandemic and reduce administrative burden. The AMA will continue to monitor the impact COVID-19 is having on practices and advocate to CMS for the appropriate relief and to ensure CMS liberally grants hardship requests due to the COVID-19 PHE. It is also our understanding the CMS QPP.CMS.GOV website is in the process of being updated with the 2020 policy and should reflect the announcement along with additional educational materials in a couple weeks. The information currently posted on the website is regarding the 2019 MIPS COVID-19 policy. CMS has also indicated that additional information on MIPS COVID-19 policy will be included in upcoming rule making.

Pat Keel Named EVP and Chief Administrative and Financial Officer for St. Jude

Semmes Murphey and Regional One Introduce MR-Guided Ultrasound Semmes Murphey and Regional One have introduced innovate technology for patients suffering from essential tremors and Parkinson’s Disease tremors. New to the Mid-South region, MR-guided focused ultrasound is a non-invasive technology designed to replace traditional surgery. Focused ultrasound allows us to perform safe and effective, incisionless therapy with little to no harm to the surrounding brain with minimal side effects. Ultrasound has the capability to pass through skin, muscle, fat, and bone without the need for incisions, electrodes or inserted probes. Ultrasound energy is non-ionizing, meaning the patient is not exposed to radiation during the procedure. During the procedure, ultrasound energy is focused on an extremely small area where tremor cells are located. The focused ultrasound leads to precise destruction of tremor cells, thereby eliminating the tremors. The whole procedure is conducted while the patient is awake inside an MRI to allow the physician to plan, guide and target the tremor area. To ensure patient safety, focused ultrasound uses an MRI thermal imaging system that measures temperature changes within the brain and the skull. Dr. Aaron Bond, a neurosurgeon at Semmes Murphey Clinic, will perform the outpatient procedure at Regional One’s East Campus on Quince.

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Pat Keel, who since 2016 has served as chief financial officer at St. Jude Children’s Research Hospital, has been promoted to the expanded role of executive vice president and chief administrative and financial officer. In the new role, Pat Keel she oversees numerous departments vital to campus operations, including Environmental Services, Facilities Design and Construction, Facilities Operations and Maintenance, Food Services, Biomedical Engineering, the Gift Shop and Security. Keel will continue to lead Human Resources and Financial Services. Keel joined St. Jude four years ago to manage financial operations. This work has included finance, the supply chain, reimbursements, the revenue cycle, managed care contracting and grants. She has played an integral part in shepherding program growth and campus expansion as outlined in the hospital’s six-year strategic plan. In her time at St. Jude, Keel has implemented programs that led to millions of dollars in annual savings for the hospital. Prior to joining St. Jude, Keel served as chief financial officer and senior vice president for University Health in Shreveport and Monroe, Louisiana. In addition, she held leadership roles with Good Shepherd Health System in Longview, Texas and CHRISTUS Schumpert Health System in Shreveport. Keel has been named to the Becker’s Hospital Review list of annual wom-

en hospital and health system leaders to know for five years in a row.

THA Issues Statement on Governor Bill Lee’s Executive Order 53 In response to Tennessee Governor Bill Lee’s executive action to grant COVID-19 liability protections to hospitals and other healthcare providers, Tennessee Hospital Association (THA) President and CEO Wendy Long, M.D., made the following statement: “Tennessee’s hospitals are grateful to Governor Lee for his latest executive action that recognizes the immense pressures faced by healthcare providers (continued on page 11)

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GrandRounds on the front lines of the COVID-19 pandemic. The liability protections granted in Executive Order 53 will provide hospitals and healthcare professionals with appropriate safeguards as providers respond to the growing number of cases and hospitalizations across our state. “Continually evolving health guidance from federal and state agencies helps ensure appropriate and effective treatment of all patients – both COVID19-positive and those receiving care for non-virus-related conditions. However, as a result of the changing guidance in the midst of the pandemic, it is vitally important to protect healthcare providers from baseless or opportunistic litigation. “Today’s order rightly does not extend protections in cases of gross negligence or willful misconduct, which underscores the commitment of hospitals to provide the safest and most effective care despite the challenges of our current environment. “I am incredibly proud of the work of hospitals over the past four months to care for communities and face the biggest public health crisis of our generation. THA and its members remain unwavering in our commitment to fight COVID-19 and support the health needs of all Tennesseans.”

detect problems in the brain that may be associated with certain brain disorders such as seizures, tumors or strokes. A typical EEG test consists of multiple electrodes attached to a patient’s scalp with adhesive. Those electrodes have several wires connected to an amplifier which further connects to a computer that measures and records the results. The setup and removal of a typical EEG test takes between 20-30 minutes. This new FDA-approved product, called zEEG from Zeto, Inc., headquartered in Santa Clara, CA, can be set up in less

than five minutes; which offers a more efficient and comfortable experience for the patient. The patient wears equipment that looks like a high-tech bicycle helmet. The electrodes do not need to be glued to the patient’s scalp, do not leave any residue on the patient and there are no wires connected to an amplifier or computer. An EEG technician at Methodist University can now be more productive and perform more EEGs in a day. The EEG and video recording are uploaded

to the cloud where a specialist can read them at their own convenience. The ZETO Instant EEG has been beneficial in the midst of the unprecedented COVID-19 pandemic. Due to the convenience of this EEG technology, PPE and exposure time for healthcare workers is reduced significantly. Fast setup and clean up decrease the exposure times for nurses and other care providers. The ZETO Instant EEG uses single-use electrodes which also reduces the risk of contamination.

Hamilton Eye Institute at UTHSC Announces Benjamin A. King, MD as their Newest Physician The Hamilton Eye Institute at The University of Tennessee Health Science Center, dedicated to improving vision and empowering lives, is pleased to welcome Benjamin A. King, MD as a staff member. Dr. King joins the practice following his 2nd fellowship in Vitreoretinal Diseases Medi- Benjamin A. King cal and Surgery at the University of Iowa Hospitals and Clinics Iowa City, Iowa. His 1st fellowship is in Ocular Oncology at St. Jude Children’s Research Hospital and University of Tennessee Health Science Center. He earned his medical degree, completed a transitional year internship in the College of Medicine and Ophthalmology residency at the University of Tennessee Health Science Center in Memphis, Tennessee. Dr. King specializes in the diagnosis and treatment of Vitreoretinal Medical and Surgery and Ocular Oncology.  

Methodist University Hospital First to Participate in Groundbreaking Study for Inpatients Methodist Le Bonheur Healthcare (MLH) is the first hospital system globally to participate in a landmark study using a first-of-its-kind EEG device. EEG stands for electroencephalogram. EEG tests are conducted to

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