SPRING/SUMMER 2015
The University of Tennessee Medical Center & the University of Tennessee Graduate School of Medicine
The Evolution of Healthcare How Standardizing Care Improves Patient Safety and Quality
For Alumni and Friends
Read More About Our Journey to Excellence on Page 16
“Where flowers bloom so does hope.”
– Lady Bird Johnson
Dogwood blossoms from the medical center healing garden.
Contents
Features Healing
6 Prostate Cancer 8 Rhythms of the Heart 10 B reathing Easier 12 W aiting for a Kidney 14 B etter Treatment
Through Collaboration
Cover Story
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The Evolution of Healthcare How Standardizing Care Improves Patient Safety and Quality
16 18 20
The Evolution of Healthcare Replacement to Recovery The Fine Art of Robotic Surgery
Education
22 23 24 26
Lottery Winner’s Endowed Gift Advancing Forensic Dentistry Through Education Practice Makes Perfect H ighest Honors
Discovery
22
28 29 30 32 34
H ealthier Moms and Babies T he Race to Image Amyloidosis C linical Trials 101 I nvestigating the Huntingtin Protein T he Impact of COPD
The University of Tennessee Medical Center and the University of Tennessee Graduate School of Medicine Frontiers
Spring/Summer Issue 2015 Editor
Becky Thompson
Publishers
Joseph Landsman James Neutens, PhD
Contributors
Jessica Benko Susan Hamilton Kandi Hodges Bonnie Horner
Design/Creative Dean Baker
Frontiers is a magazine produced by The University of Tennessee Medical Center and the University of Tennessee Graduate School of Medicine. It is designed to showcase the unique benefits of having an academic medical center in East Tennessee. Copyright Š 2015 The University of Tennessee Medical Center All Rights Reserved EEO/TITLE VI/TITLE IX Sec. 504/ADA
Contact us at Frontiers
2121 Medical Center Way, Ste. 300 Knoxville, Tennessee 37920-3257 Telephone: 865-305-6845 Fax: 865-305-6959 Email: frontiers@utmck.edu utmedicalcenter.org or http://gsm.utmck.edu
In Every Issue 5
32
27
Ask the Expert: What is a hospitalist? 5 Minutes with a Pharmacist: Springtime Outdoor Protection
Visit us online for more information about Frontiers: bit.ly/UTFrontiers Links are case sensitive.
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&Friends,
Dear Alumni
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When you consider medical care, we hope The University of Tennessee Medical Center is top of mind for delivering exceptional care with compassion and respect. Many know us as an academic medical center where knowledge and skills are taught to tomorrow’s clinicians and researchers. To others, we are an expansive medical complex that offers hope and healing through lifesaving services and advanced technologies. But most importantly, we are a community of people dedicated to caring for patients and families that seek medical attention during their most vulnerable time. No one will deny that navigating today’s healthcare environment is a challenge. Terms such as healthcare reform, clinical pathways and standardized care are commonly heard today. We all know that healthcare is a business. Yet it is the one business that truly touches people at their most vulnerable points throughout their lives.
Because of this, all of us in the business of healthcare must never forget that medicine is also the practice of compassion. At The University of Tennessee Medical Center and UT Graduate School of Medicine, we are more than buildings and technology. Business models show that reform is needed to help reduce costs and assist with access. Standardized care benefits patient safety, and clinical pathways manage the quality of care. However it is the personalization of care that helps our patients take ownership of their health and wellness. In this issue of Frontiers, you will learn how our commitment to the health of our community continues as we grow new services, provide cutting-edge treatments, expand our educational programs and lead research that advances the frontiers of medicine. Thank you for allowing us to care for you and your family.
Joseph R. Landsman, Jr. President and Chief Executive Officer University Health System, Inc.
Our Mission
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To serve through healing, education and discovery
We Value
Integrity • Excellence • Compassion Innovation • Collaboration • Dedication
James J. Neutens, PhD Dean UT Graduate School of Medicine
Our Vision
To be nationally recognized for excellence in patient care, medical education and biomedical research
ASK THE
EXPERT THE PHYSICIAN IS IN
Hospitalists are board-certified physicians who do not have an out-of-hospital practice. Instead they choose to manage the care of hospital patients. Hospitalists have a host of responsibilities in order to expedite treatment and coordinate care between the hospital and primary care physicians. Q: Who are the hospitalists? A: The University of Tennessee Hospitalists are a group of highly qualified and experienced physicians who specialize in caring for patients while they are hospitalized. Our care team of board-certified physicians and nurse practitioners is on site 24 hours a day to continually monitor your care.
and provide as much information as possible about your illness. The process is similar to what your physician does when referring you to a specialist for additional tests or treatment. During the course of your hospitalization, your hospitalist and primary care physician may talk further regarding your treatment.
Q: Why isn’t my primary care physician (PCP) here? A: As more medical care moves to the outpatient setting, there are increasing demands on primary care physicians (PCP) and their offices. By partnering with a dedicated team of hospital-based physicians that focuses on inpatient care, your PCPs are able to devote all their time to meeting you and your family’s needs in the office.
Q: How does it work? A: Your hospitalist knows every specialist and department in the hospital, which allows them to assist you through a smooth and speedy recovery process. Your hospitalist will visit you at least once each day, more if needed.
Q: How does the hospitalist know about me? A: Your PCP and the hospitalist are able to inform you of your condition
JJ Janoyan, DO, SFHM, medical director of UT Hospitalists.
Q: Who will see me after discharge? A: When you are discharged from the hospital, your care will be transitioned back to your PCP. Your hospitalist will communicate with your PCP regarding your treatment needs, help arrange follow-up care and prescribe any necessary medications. It is important that you visit your primary care physician soon after your discharge to make sure your post-hospitalization care needs are met. If you do not have a primary care physician, our care team will help you establish care with a physician in your area.
In case of emergency, your hospitalist is never very far away. With care team members in the hospital at all hours of the day and night, it’s easier for you and your family to communicate about your illness.
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Healing
Randy Snipes surveyed all of his options to treat his prostate cancer. His journey led him to robotic surgery treatment at The University of Tennessee Medical Center Cancer Institute. Snipes is now free of prostate cancer and back to his normal life.
PROSTATE
CANCER
Treatment Options Close to Home
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Randy Snipes, a mechanical engineer, has always been diligent about scheduling regular physician visits and monitoring his health. With a family history of prostate cancer and a previous complex colon surgery, he hoped his proactive approach would help minimize risks of the unknown.
In January 2014, however, a routine blood test revealed that his prostate-specific antigen (PSA) level was abnormally high. PSA is a protein produced by the prostate gland and high levels can indicate that something is wrong. A follow-up biopsy revealed the news: Randy had stage 2 prostate cancer. Post-operative pathology work further revealed that the cancer was stage 3.
At age 60, Randy was about to begin one of the most difficult journeys of his life. Together with his wife, Sherrie, the Snipes began discussing their options with local specialists. Randy says they had hoped to get the information they needed and then make an informed decision with the help of his physician. As Knoxville residents, they also wanted to receive medical care close to home.
The Options With a multitude of information, the Snipes considered four options: robotic surgery, open surgery, traditional radiation therapy and proton therapy. Ultimately, they favored robotic surgery for the removal of the prostate because the minimally invasive nature of the procedure creates less pain, scarring and blood loss as well as shorter recovery times. In February 2014, Randy’s surgeon said it was too risky. In robotic surgery, surgeons control their tools via a high-tech, 3-D interface in order to make tiny incisions and access the affected area(s). The surgeon told Randy that the scarring and mesh in his lower abdomen – a result of his earlier colon surgery – would make reaching the prostate through such small incisions extremely difficult. 6 - Frontiers
Disappointed, the Snipes began researching again. Each procedure they considered was unique and offered a number of pros and cons. Randy says, “When considering options, you should always consult with your team of healthcare providers in order to come up with an answer your family is completely comfortable with.” So their research continued and led them to a new physician.
Specialists Close to Home In June 2014, Randy’s new physician was adamant that he make an appointment with Wesley M. White, MD. That decision changed his life. Wesley M. White, MD, a board-certified urologist at the Cancer Institute and assistant professor at the Graduate School of Medicine, agreed to review Randy’s case. Undaunted by its complexities, White, who serves as director of Laparoscopic and Robotic Urologic Surgery, agreed to see Randy. “He was very flexible and took into consideration my work and travel times when guiding my choice,” Randy says. To the Snipes’ relief, White agreed to perform the surgery using the da Vinci Surgical System, a robotic surgical system that allows surgeons greater precision and control. Says Randy, “I was very appreciative of White taking on the challenge. He had experience working with people who had mesh and scar tissue in the abdomen and was very comforting.” Though the procedure itself took twice as long as usual due to Randy’s extensive scarring, the surgery’s outcome was positive. The cancerous prostate was successfully removed, giving Randy a new lease on life.
Getting His Life Back Because of the minimally invasive nature of the robotic surgery, Randy spent only one night in the hospital. And, despite having to slow down a bit once home, his recovery was steady. As is typical following a surgery of this nature, Randy’s recovery time was about six weeks. Taking advantage of White’s expertise with the da Vinci Surgical System allowed him to get back to work faster. Though Randy continues to monitor his PSA levels closely, everyday life has returned to normal. The Snipes credit White with saving Randy’s life. White’s compassion, expertise and willingness to take on a challenging case turned what seemed to be impossible into a reality. Read more about robotic surgery on page 20: “The Fine Art of Robotic Surgery.”
Prostate-Specific Antigen (PSA): What it is and Why it Matters
PSA is a protein produced by the prostate gland and high levels can indicate that something is wrong. The PSA test – which uses a blood sample – is performed to help diagnose and follow prostate cancer in men. An annual test, it is most often performed to screen men: 1. Ages 50 to 75, if no other risk factors are present 2. Ages 40 – 45, if they are considered to be at higher risk of developing cancer, including a family history and ethnicity PSA testing is an important tool for detecting prostate cancer but it is not foolproof. Always talk to yourphysician about what is right for you.
Randy Snipes with his surgical oncologist, Wesley M. White, MD, assistant professor, whom he credits with saving his life and taking on the challenge of his unique cancer case.
To learn more about the Cancer Institute and whether robotic surgery might be a good option for you, visit us online at utmedicalcenter.org/cancer-institute.
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Rhythms of the Heart
Treatment Options for Cardiac Arrhythmias
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Millions of people are affected every day by cardiac arrhythmias. Some are harmless, while others may put someone at risk for serious complications.
Characterized as disorders of either heart rate or heart rhythm, arrhythmias can make the heart beat too fast, too slow, or irregularly. That’s why cardiac electrophysiology (EP) – the study of the heart’s electrical system – is one of the fastest growing services offered at The University of Tennessee Medical Center’s Heart Lung Vascular Institute. EP studies are typically conducted to help physicians diagnose and treat a vast array of arrhythmias. These are critically important because an untreated arrhythmia can lead to extreme fatigue, heart disease and even stroke. For more than 20 years, physicians at The University of Tennessee Medical Center have provided patients with access to cutting-edge treatment options and devices, helping meet the diverse cardiac needs of our region.
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The three cardiac electrophysiologists who are also clinical faculty on the medical center’s staff — Jeffrey Hirsh, MD, Jeremy Mahlow, MD, and James Cox, MD — have more than 40 years of combined experience treating atrial fibrillation and other heart rhythm irregularities.
The Electrophysiology Lab
The medical center’s EP Lab continues to distinguish itself in this region through its depth of experience and innovative leadership. The team of experts, including board-certified electrophysiologists, registered nurses, radiologic technologists and cardiovascular technologists, is specially trained in the leading techniques needed to evaluate and treat arrhythmias. The lab, where EP studies are conducted, helps physicians determine the type of treatment plan for each patient. The medical center’s Heart Lung Vascular Institute offers a full spectrum of treatment options, from medication and ablation therapies to implantable devices like pacemakers and defibrillators.
Region’s Only Atrial Fibrillation Center
More than two million Americans currently suffer from atrial fibrillation, or AFib. Known as the most common type of irregular heartbeat, more than 300,000 new AFib cases are diagnosed each year. AFib is characterized as an abnormal, irregular heartbeat and can significantly increase the risk for heart disease and stroke. In response to a growing population of patients with AFib in East Tennessee, the Heart Lung Vascular Institute opened the region’s only Atrial Fibrillation Center in 2008. More than 1,000 patients were treated at the center in 2014. The AFib Center continues to provide the most innovative treatment options for the region and produces excellent outcomes for patients.
Cardiac Ablation Therapy
Cardiac ablation is a catheter-based therapy used to scar or burn away small areas of tissue in the heart. Using advanced 3-D mapping, electrophysiologists can more accurately target these abnormal tissues. The medical center’s team offers ablation therapy for numerous types of arrhythmias, including atrial fibrillation, supraventricular tachycardia and ventricular tachycardia. Many treatments can even be performed in an outpatient setting sometimes allowing patients to return home that same day.
Patient Receives First Mini-Pacemaker Implant
On April 25, 2014, Betty Bilbrey became the first patient in the United States to receive a mini pacemaker implant post FDA approval. The procedure was performed by electrophysiologist William J. Mahlow, MD, clinical assistant professor, and has significantly impacted Betty’s everyday life for the better.
Betty says, “The unique thing about the mini is its size. There’s no weight. I don’t feel it and I am not conscious of it.” The work done by Mahlow and the health care team at the medical center has given Betty the peace of mind she needed. She knows that her care team is constantly monitoring her condition and says, “It’s a wonderful feeling.”
The Mini Pacemaker
More than 20 years ago, physicians at The University of Tennessee Medical Center performed the first cardiac catheter ablation therapy in East Tennessee. In 2014, the medical center was the first in the United States to place a mini pacemaker post-FDA approval (see Betty’s story, sidebar). Though traditional options are used when appropriate, the medical center continues to set the standard of innovative cardiac care for the region by offering two new types of implantable devices for patients with arrhythmias, the mini pacemaker and the subcutaneous implantable cardioverter defibrillator (S-ICD).
The mini pacemaker — the smallest device available today — was specially designed to have a lower, thinner profile. Traditional pacemakers are surgically implanted under the skin in the upper chest and are often visible. However the mini pacemaker reduces the device’s visible profile while decreasing the risk of skin breakdown in thinner patients. The S-ICD is very different from its traditional defibrillator counterpart. Entirely under the skin and not inside the heart or blood vessels the S-ICD helps some patients avoid possible complications. The S-ICD also lowers the risk for infection and can be removed safely and easily if necessary.
Cardiac patient Betty Bilbrey Patients who are interested in an evaluation may request a physician referral or email our Atrial Fibrillation Center at heartlungvascularinstitute@utmck.edu.
The medical center is the only facility in the region to provide laser lead extractions, the safest, most effective approach for removal of chronic pacemaker or ICD leads. The procedure involves passing a laser tip tube over the old lead to cut through scar tissue. Spring/Summer 2015 - 9
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Breathing Easier State-of-the-Art Treatment for Complex Breathing Problems For the fourth consecutive year, The University of Tennessee Medical Center has been recognized in the “America’s Best Hospitals” edition of U.S. News & World Report. Ranked nationally in pulmonology, the medical center’s Heart Lung Vascular Institute provides state-ofthe-art treatment for breathing problems through its interventional pulmonology (IP) program. IP is a specialty within pulmonary medicine, where physicians use advanced methods to diagnose and treat patients suffering from lung cancer, pleural diseases and other airway disorders. IP services are provided in both inpatient and outpatient settings. The Heart Lung Vascular Institute offers a full complement of noninvasive and minimally invasive treatments and technologies for pulmonary patients. The outpatient IP clinic provides quick access for patients experiencing breathing problems, including those in need of immediate treatment. For more complex problems, however, the institute’s team of pulmonary experts — including thoracic surgeons and interventional pulmonologists — provide advanced diagnostic treatment options for central airway obstructions, cancers, airway collapse and other disorders that cause breathing difficulties.
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Advanced Diagnostic Treatment Options Endobronchial Ultrasound (EBUS)
This minimally invasive service performed at the IP clinic helps diagnose lung cancer, infections and other inflammatory diseases. EBUS is an outpatient procedure that allows physicians to obtain tissue and fluid samples from the lungs and surrounding areas. Physicians use EBUS to provide real-time imaging of airways, blood vessels, lungs and lymph nodes, including lymph node biopsies. Visit us online for more information: http://bit.ly/1OInOo2.
For East Tennesseans who are dealing with conditions such as lung cancer, chronic obstructive pulmonary disease (COPD), asthma or pneumonia, this means close-to-home access to the latest most effective diagnostic and treatment resources.
Electromagnetic Navigational Bronchoscopy (ENB)
More than two-thirds of all lung lesions are too small or too difficult to reach through traditional procedures. ENB is another advanced treatment option that is often performed in an outpatient setting. It enables physicians to more easily reach and biopsy those hard-to-reach lesions. Using a GPS-type technology called iLogic, ENB navigates deep into the lungs to obtain samples or to biopsy lesions. Using ENB, physicians can often diagnose lung cancer earlier than traditional means — sometimes even before symptoms appear. For patients, access to ENB technology means a shorter time spent in the hospital, lower risk of complications and fewer aftereffects. Visit us online for more information: http://bit.ly/1dwyjKa.
Bronchial Thermoplasty (BT)
More than 22 million Americans are affected by asthma, costing the United States approximately $18 billion per year. Knoxville ranked 7th out of 100 cities as one of the most challenging places to live with asthma in 2015 according to the Asthma and Allergy Foundation of America. The medical center provides BT services to help improve the quality of life for the many asthma sufferers in the region. BT is a non-drug procedure that works to reduce severe asthma symptoms in patients 18 years and older, who have not had success when using standard asthma medications for control. It is a minimally invasive, outpatient procedure that targets and treats a different area of the lungs. In the procedures, performed during three separate visits, a specially trained pulmonologist inserts a tube into the airway while the patient is asleep. The wires on the end of the tube are then heated in order to reduce some of muscle tissue lining the airway. Once the three procedures are performed, the treatment is considered complete. BT has proven to be a successful treatment option for improving the quality of life of asthma sufferers and has helped decrease the number of severe asthma attacks and resulting hospitalizations. The University of Tennessee Medical Center’s Interventional Pulmonology services is the only program performing all three treatment options — EBUS, ENB and BT — in the region, helping you breathe easier. Visit us online for more information: http://bit.ly/1QOrCSZ. Spring/Summer 2015 - 11
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Waiting for a Kidney More than 100,000 people in the United States are currently waiting for a kidney transplant — 2,407 of those are Tennesseans. The University of Tennessee Medical Center offers the only kidney transplant program in the region and has performed more than 1,100 transplants since 1985. Unfortunately the average wait time for an individual needing a new kidney is one to three years. The supply is not able to keep up with the demand and more than 4,400 people die each year while waiting. That’s why it’s important to understand the critical need for kidney donors and the dramatic, life-saving impact they can have on patients in need.
Three Types of Transplant Donors Transplant surgeon and assistant professor at The University of Tennessee Medical Center, Alex Cantafio, MD, describes the kidney as “a very intelligent filter,” adapting as it maintains the body’s salt, fluid and pH balance. When a person’s kidneys fail, a transplant is often the best option. There are three types of kidney donors: living-related, living-unrelated and cadaver. Living donations are given by a family member, spouse, friend or in many cases perfect strangers, whereas a cadaver donation is given by someone who has recently passed away but had not suffered from kidney disease or injury. Research shows that a living donor kidney, in contrast to a cadaver kidney, will not only function better but also lasts longer. Whereas success rates for a living donation are nearly 95 percent, often with earlier function and fewer medications. Living donors can live normal, healthy lives after the surgery, as the remaining kidney maintains the function to make up for the donated kidney. Though blood and tissues must closely match, a kidney donor and the recipient do not have to be blood related. Because of this common misconception the medical center works to educate the community on kidney transplants and why living donations are critically important. Travis Allen and Brittany Wilson, two of the medical center’s patients, know all too well about the importance of living kidney donors.
Travis Waits Again
Travis Allen is a Tennessee native currently on the kidney transplant waiting list.
Travis, 27, a Tennessee native, was diagnosed with chronic renal failure at age eight. At age nine, he was fortunate to receive a living kidney from his mother. The kidney she donated lasted 13 years.
Even the most successful transplants cannot last indefinitely. Since 2010, Travis has been on the waiting list for a second kidney. As a musician, sports enthusiast and someone who loves spending time on the water, Travis works hard to stay active and participate in as many activities as possible. 12 - Frontiers
“I want others to look at my life and what I am accomplishing and not see someone hindered by this disease, but someone who has thrived.”
Two Recipients Explain the Importance of Living Donors But, his everyday routine is challenging. Travis adheres to a strict diet, and he receives dialysis three days a week for four-hour treatments beginning at 4:30 a.m. With the help of his physician, Oscar Grandas, MD, a transplant and vascular surgeon and associate professor at The University of Tennessee Medical Center and Graduate School of Medicine, Travis is optimistic. “I want others to look at my life and what I am accomplishing and not see someone hindered by this disease, but someone who has thrived,” he says. As he continues to wait, Travis is pursuing a master’s degree and works in the Public Policy Institute at Western Carolina University. Having already benefitted from the success of one kidney transplant, Travis understands better than most the urgent need for living donors — and for educating those who have not been impacted by a transplant. He says, “A transplant is freedom to live your life and do all the things you hope and dream to accomplish. In order for those of us needing a transplant to get this new lease on life, it takes heroes like my mother and others who are willing to donate — giving hope for a better life.”
Brittany’s Second Chance Brittany Wilson, 25, was born with polycystic kidney disease and moved to Bristol, Tennessee, in 2001, with her grandfather. By March 2013, Brittany was in total kidney failure. Her disease required that she begin peritoneal dialysis immediately; each night at home she received an eight-to-nine hour treatment using a port in her abdomen for access. Brittany was restricted by diet limitations, monitoring needs, travel restrictions and she was not allowed to swim. After two years and missed chances for four kidneys that went to other recipients, Brittany’s life changed for the better. In October 2014, Brittany, a pharmacy tech, made friends with a new coworker and pharmacy student, Alea Moore. By February 2015, Moore was confirmed as a living kidney donor match.
Brittany Wilson was one of a few thousand individuals in East Tennessee who were waiting for a kidney to save her life. Today Brittany has a new kidney and is on her way to living a long, fulfilling life.
With the only kidney transplant program in the region, the medical center focuses on educating the public about living kidney donation.
On March 4, 2015, Grandas, performed the transplant. By mid-March, both Brittany and Alea were in full recovery. Now, Brittany says, the two friends “are bonded for life.” Because of her donor’s compassion and willingness to donate, Brittany is already living a healthier life. She is looking forward to resuming her volunteer work at church, traveling without the complication of dialysis, and living a long, fulfilling life.
To find out how you can become a living donor, call the Center for Transplant Services at 865-305-9236. For more information about the transplant center, visit us online at utmedicalcenter.org/transplant.
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Healing Michael T. Walsh, MD, clinical assistant professor, leads bimonthly neuro-oncology tumor conferences in collaboration with the Brain and Spine Institute and Cancer Institute. Multidisciplinary specialists within each Center of Excellence collaborate and review patient cases to plan a course of treatment that is unique for each patient.
Better Treatment Through
Collaboration Centers of Excellence Combine Forces
Collaboration is often the cornerstone of outstanding patient care. The University of Tennessee Medical Center brings collaborative care to a new level with a unique working relationship between two of our Centers of Excellence — the Brain and Spine Institute and the Cancer Institute.
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“Being diagnosed with a brain or spinal tumor can be a scary time for patients and it’s easy to feel overwhelmed with many treatment options and seeing various specialists. That’s why the Neuro-Oncology Program is unique. Our Nurse Navigator and biweekly multidisciplinary tumor conferences result in the coordination of the patients’ care from diagnosis through treatment. I firmly believe that beating cancer starts with empowering patients and giving them hope. This program helps us take a large step in the direction of treating the whole patient.” – Michael T. Walsh, MD, clinical assistant professor
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The Formation of the Neuro-Oncology Program The University of Tennessee Medical Center’s Neuro-Oncology Program combines the strengths of both the Brain and Spine Institute and Cancer Institute to provide state-of-the-art treatment for patients with brain and spine tumors, benign and malignant. The two Centers of Excellence have a successful tradition of working together to minimize cancer’s impact on a patient’s quality of life. In addition to the effects of cancer, treatments and related disorders can often cause other health problems for patients. The team provides expert multidisciplinary care for patients who suffer neurological complications from cancer and related problems. Michael T. Walsh, MD, a neurosurgeon and clinical assistant professor, leads the team of skilled physicians and caregivers that serves these patients from diagnosis through treatment. The team includes board-certified medical oncologists, radiation oncologists, radiologists, pathologists, neurologists and neurosurgeons, all working together to develop a plan that is unique for each patient. Neurointerventional radiologists offer the latest minimally invasive vascular surgery options for aneurysms, strokes and other life-threatening conditions. Neurointensivists, including specially trained anesthesiologists and therapists, provide the best in critical care. Treatment options can include surgery, minimally invasive surgical techniques, chemotherapy, radiation or the use of state-of-the-art technology such as TrueBeam and CyberKnife radiosurgery. The Neuro-Oncology Program also participates in a broad range of clinical oncology trials. These trials can give patients access to new treatments as they explore ways to prevent, diagnose and treat cancer and to improve patients’ quality and length of life.
Types of Conditions Treated by the Team: The most common conditions treated are benign and malignant tumors of the nervous system, including the brain and spine, such as: • Acoustic Neuromas • Gliomas • Meningioma • Metastatic Tumors • Pituitary Tumors • Skull Base Tumors • Spinal Tumors
What is a Nurse Navigator?
A Neuro-Oncology Nurse Navigator acts as the patient’s liaison throughout the journey from diagnosis through treatments. The Nurse Navigator is available at the time of a patient’s diagnosis to provide one-on-one support for patients and their families. The Nurse Navigator assists in coordinating and implementing patient care activities by keeping in close contact with the patient and family to provide information and support, as well as coordinating tests and treatments. Randi Ray, RN, BSN, OCN, is the Neuro-Oncology Nurse Navigator who helps coordinate treatment and provides support for both patient and family.
The Nurse Navigator also participates in the medical center’s multidisciplinary neuro-oncology tumor conferences and coordinates the treatment plan according to conference recommendations.
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The Evolution of Healthcare How Standardizing Care Improves Patient Safety and Quality
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The healthcare industry is at a turning point in its evolution, partly as a result of the Affordable Care Act. Physicians and nurses are faced with a paradigm shift—from operating their individual private practices to becoming “providers” coordinating care under a lean business infrastructure. The lack of standardized care has caused fragmented silos, lacking coordination and communication. The result is skyrocketing healthcare costs and difficulty making improvements in the quality of patient care. Healthcare spending is projected to account for more than 19 percent of the Gross Domestic Product by 2023. To lead this transformation, The University of Tennessee Medical Center has adopted a strategy to redesign our healthcare delivery system so that it makes sense to our patients and families, our healthcare providers and our payers (e.g., insurance companies). Standardization of the delivery of care not only strives to improve the quality of patient care but also to position the medical center to succeed under emerging payment models in Medicare and the private market.
“We’re trying to build a mechanism centered on the patient that provides predictable, reliable quality outcomes for the people we serve. The rest of it becomes irrelevant because no matter what the payment scheme is or what the contracts look like, you’re going to be performing very well under those structures.” – Joseph Landsman, CEO of The University of Tennessee Medical Center
Redefining our Healthcare Delivery Through Patient Care Pathways
One way the medical center aims to standardize excellent care is through our Patient Care Pathways initiative. At the medical center a pathway is a “method by which best-practice, published clinical guidelines are applied to patient care in a standardized, patient-centered fashion and which allows for multiple disease states.” For example a patient may have heart disease, diabetes and need a knee replacement. Because pathways standardize care by disease state, providers can deliver the best care for each issue. A pathway can focus on an acute illness like a stroke, a chronic medical condition such as heart failure or an isolated condition like pregnancy. It can also cover procedures major and minor, like open-heart surgery, colonoscopy or a lumbar puncture. Each disease-specific pathway is standardized across all disciplines, which eliminates the variance in outcomes and follows evidence-based practices. This standard infrastructure provides a platform to personalize care for each patient’s unique medical circumstance. The goal of Patient Care Pathways is to improve the quality of care, reduce risks, increase patient satisfaction and increase the efficiency in use of resources. Pathways are designed by a multi-disciplinary team of clinicians including physicians, nurses, case managers, pharmacists and any ancillary team members who may contribute to the care of the patient. The process of standardizing care empowers this multidisciplinary team to redefine healthcare delivery by starting with the patient’s perspective, including eliminating all non-value-added tasks. Because clinicians are intimately involved in the design of the pathways, they have become their champions. Patient Care Pathways improve quality care and ensure the medical center is a low-cost, high quality provider.
Improving Safety and Quality
Since developing Patient Care Pathways in 2012, the medical center has observed year-over-year improvements with reductions in acute care and critical care infections achieving rates that are now better than National Healthcare Safety Network benchmarks. There are over 100 Patient Care Pathways deployed, covering 80 percent of patients admitted to the medical center. The improvements in safety and quality are significant. In addition to a decline in the most common of hospital infections, the medical center has improved in five key areas: higher pathway compliance, lower mortality and complications, decreased inefficiencies and a dramatic reduction in readmissions. Today’s economic environment makes it important for healthcare providers to produce the best possible outcomes while keeping costs under control. To do this, The University of Tennessee Medical Center has adopted best practices, such as Patient Care Pathways, from various industries and top performers to deploy and implement efficient and quality care. The journey to standardization is the medical center’s aim to continuously strive to improve the delivery of quality care for patients and their families. Spring/Summer 2015 - 17
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Anterior hip surgery uses a minimal incision on the front of the hip. In this approach, the surgeon is able to move the muscles aside rather than cutting through them.
Replacement to Recovery
Anterior Approach Hip Replacement Puts You Back on Your Feet in Less Time
More than 330,000 people undergo hip replacements every year in the United States, most of them completed through the traditional posterior (back) approach. For the last decade direct anterior (front) approach surgery has gained popularity among orthopaedic surgeons and patients. According to Michael Eilerman, MD, an orthopaedic surgeon and clinical instructor at The University of Tennessee Medical Center Advanced Orthopaedic Center, who began performing anterior approach surgery almost exclusively six years ago, Knoxville has been slow to adopt this technique. “I think you’ll see in the future more and more hips will be put in this way,” he says. The Advanced Orthopaedic Center has performed more than 1,000 of these procedures, more than any other hospital in the region. Patients say they prefer the anterior approach because of the quicker recovery time and lower risks.
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What is Anterior Approach Hip Replacement? Anterior hip replacement is a minimally invasive approach that allows the surgeon to access the hip joint from the front of the hip. In this approach, the hip is replaced by working between the muscles and tissues without detaching them from either the hip or thigh bones. The Advanced Orthopaedic Center houses three state-of-the-art hana® fracture tables, designed specifically for use in the anterior approach, which allows for better positioning and access to the joint. During the anterior approach procedure, a four-inch incision is made on the front of the hip that allows the surgeon to access the hip socket, remove damaged bone and cartilage and insert prosthetic components. The surgeon inserts a metal stem into the femur and places a ceramic or metal ball on the stem. He then places a new socket component where the ball fits and a smooth liner to provide the new hip with excellent movement. The same components are inserted in traditional approaches, however the placement of the incision is from the posterior approach or back of the leg where the surgeon places an 8 to 10inch incision that cuts through a thick mass of muscle and connective tissue to reach the hip joint. This surgery has the highest rate of dislocation and requires a longer recovery period with stricter limitations on movement. A third option is the lateral (side) anterior approach, where the surgeon reaches the hip joint from the side of the body. This approach can reduce the risk of dislocation but it has a higher rate of a severe limp, caused from hip muscles being damaged or weakened by surgery.
What are the Benefits? The anterior approach technique results in a shorter hospital stay, quicker
recovery time, reduced pain and more normal function after hip replacement. “Patients are walking the day of surgery and reach milestones quicker,” says William Oros, MD, orthopaedic surgeon at the Advanced Orthopaedic Center. Nearly 95 percent of the hip replacements he performs are now done with the anterior approach. “Our practice has made a huge commitment to this because of how well people are doing after surgery,” he says. Most patients find complete or nearly complete pain relief. “It’s almost like outpatient surgery for some,” Oros says. “They can go home the next day if they have the support they need.” By comparison, patients who have had the posterior approach usually spend two to three days in the hospital, followed by a week or two in rehabilitation. With anterior approach surgery, patients usually spend two weeks on a walker, six weeks with a cane and, if muscle tone is good, can play tennis in two or three months. Artificial hip joints can last 25 years or longer. “We used to think that we should wait much longer to do surgery because the hip would wear out,” says orthopaedic surgeon Brian Tonne, MD. “We’ve changed our thinking, especially with younger patients with injuries. A lot of design features have changed. There have been significant improvements in the prosthetics, so they now have little wear.”
In addition to performing hip replacements, the Advanced Orthopaedic Center has a state-of-the-art facility with an interdisciplinary approach to trauma and fracture care, joint replacement, treatment of degenerative musculoskeletal diseases and outpatient surgery such as knee, hip and shoulder arthroscopy. If you are interested in anterior approach hip replacement, explore your options with our surgeons who are specially trained in this technique by calling 865-305-6970.
Joint Replacement Center: Promoting Wellness The Advanced Orthopaedic Center has a designated Joint Replacement Center that promotes a wellness approach to knee and hip replacement. Patients receive extensive preoperative education. The center’s coordinator and a physical therapist teach patients what to expect — and what’s expected of them. The joint program has dedicated nurses, plus physical and occupational therapists who provide individualized recovery plans and include group therapy for optimal recovery and mobility. Their goal is to return each patient to a better, healthier life.
The surgeons at the Advanced Orthopaedic Center provide a whole approach to orthopaedic care. From left, Brian Tonne, MD; Michael McCollum, MD; Michael S. Eilerman, MD; William Oros, MD; and Philip G. McDowell, Jr., MD.
Spring/Summer 2015 - 19
Healing
Minimally Invasive Treatment for Faster Recovery
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Robotic surgery has been an important advancement in the evolution of minimally invasive surgical treatments. The University of Tennessee Medical Center has become a leader in robotic surgery with its highly trained surgical team and state-of-the-art da Vinci Surgical System.
The medical center currently has more than 20 surgeons with extensive expertise in treating many specialties with robotic surgery.
What is Robotic Surgery? Robotic surgery enables surgeons to use micro-instruments, guided by a 3-D camera, to maneuver through very small one- to two-centimeter incisions. With the da Vinci system the surgeon sees a magnified view of the inside of the patient’s body and conducts the surgery using micro movements. This method minimizes the pain and risk associated with a surgical procedure while increasing the likelihood of a fast recovery. The da Vinci system consists of an ergonomically designed surgeon’s console, a patient cart with four interactive robotic arms, a high-performance vision system and patented EndoWrist® instruments that fully replicate human wrist movements. Robotic surgery enhances surgical capabilities by allowing a surgeon’s hand movements to be scaled, filtered and translated into precise motions. These motions are entirely controlled by the hands of a surgeon who undergoes training in general open surgery and laparoscopic surgery, as well as specialized training using the da Vinci system.
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What is Robotic Surgery Used For? Surgeons at the medical center use robotic techniques for general surgeries, such as gall bladder removal, hernia repair, bowel resection and bariatric surgery, as well as surgeries in a number of other specialties:
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Cardiac surgeons treat numerous heart defects and diseases with robotic procedures, including valve repair and coronary artery disease.
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Head and neck surgeries such as radical tonsillectomy and treatment of various cancers of the head, neck, mouth and throat, as well as surgeries to treat gastric reflux and other esophageal problems.
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Urologists perform bladder and prostate cancer surgeries, kidney removal, ureteral implants and scar tissue removal. Urogynecological surgeries include repairing bladder and bowel incontinence and pelvic organ prolapse problems.
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Gynecological surgeons use robotics to treat fibroid tumors and endometriosis, perform hysterectomies, remove damaged or diseased ovaries and cysts and treat various types of gynecological cancers.
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Surgeons use robotic surgery to treat many other types of cancers, including lung, colon and rectal cancers; to remove tumors; and to perform biopsies on hard-to-reach lymph nodes.
What are the Benefits? As with traditional laparoscopic surgery, robotic surgery means smaller incisions — a clear benefit to the patient. Robotic surgery also gives surgeons increased dexterity and range of motion, as well as clearer visibility and greater access to areas of the body that are difficult to reach. These enhanced capabilities allow surgeons to complete intricate procedures through small — even tiny — incisions. Smaller incisions mean less pain, blood loss and scarring; less time in the hospital; a shorter recovery time and a quicker return to day-to-day life. For example patients who undergo removal of the prostate with the da Vinci system often have a 50 percent shorter recuperation time.
This minimally invasive treatment option is an effective alternative to traditional surgery and laparoscopy. Speak with your physician about robotic surgery. If you don’t have a physician, call 865-305-6970 to make an appointment. Our experienced robotic team includes: From left, Hannah Aldmon, BSN RN; Stephanie McCurdy, BSN RN CNOR; Scottie Olmstead CST; Jessica Housewright RN; Kelly Vance CST; Connie Sapien RN; Tonya Carpenter CST.
Spring/Summer 2015 - 21
Education
Lottery Winner’s Endowed Gift Creates New Professorship of Cardiothoracic Surgery
“This is all about gratitude,” Cockrum says. “If Gaines and the team at UT Medical Center hadn’t saved my life four years ago, I wouldn’t have been here to buy that lottery ticket.” – Roy Cockrum, Lottery Winner
For more information about donations visit us online at utmedicalcenter.org/make-a-gift.
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Roy Cockrum announcing his gift that will support heart and chest disease research.
June 11 is a date Roy Cockrum will never forget. On June 11, 2010, he underwent heart surgery at The University of Tennessee Medical Center to save his life. On the same date but four years later, Cockrum won the lottery — $259.8 million — as the Powerball Jackpot winner. Cockrum announced his endowed gift of $1 million in honor of Thomas E. Gaines, MD, associate professor and chief of Cardiothoracic Surgery and the physician who led his heart surgery on that memorable day in 2010.
The Thomas E. Gaines MD Professorship of Cardiothoracic Surgery Endowment will support research, patient care and education for the Heart Lung Vascular Institute. This is the UT Graduate School of Medicine’s second endowed professorship, in addition to the Robert H. Cole Professorship in Neurosciences. “This is all about gratitude,” Cockrum says. “If Gaines and the team at UT Medical Center hadn’t saved my life four years ago, I wouldn’t have been here to buy that lottery ticket. These physicians help hundreds of people heal and enable them to go on to do great things. I’m thankful to be one of those individuals who is here today and able to pay it forward because of their expertise and commitment to caring for our community.” Gaines says, “His generosity will help us learn new techniques, provide ongoing training for team members and recruit talented people to join us. The gift will be a resource to support research that can be conceived and carried out by our own colleagues here at the medical center and applied to the heart valve problems and other heart and chest diseases we see here in East Tennessee.”
Paige Smalley, DMD, is the first Forensic Dentistry Fellow, learning the skills she needs for forensic odontology board certification.
“I find it interesting that by using something as little and unique as a tooth, I can help families identify a loved one.” – Paige Smalley, DMD
Forensic Center forensic anthropologist, the fellow participates in dental identifications including oral autopsies and bite mark analysis. Smalley is also participating in a research project with Marks and William Bass, PhD, founder of UT’s forensic anthropology program. The program will provide forensic experts with another tool to determine approximate time of death.
Advancing
Forensic Dentistry Through Education
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Forensic dentistry is the method of identifying people through the unique characteristics of their dental structures. While these techniques are often featured in crime scene dramas, there are fewer than 100 dental experts in the United States and Canada certified by the American Board of Forensic Odontology. The requirements for board certification are rigorous, but a new fellowship program will give dentists the education they need to enter this field.
Using resources available through the Knox County Regional Forensic Center, the Department of General Dentistry has launched a new Forensic Dentistry Fellowship, chaired by O. Lee Wilson, DMD. A graduate of UT’s dentistry residency, Paige Smalley, DMD, is the first to participate in the one-year fellowship program. Under the guidance of Murray Marks, PhD, Associate Professor of General Dentistry and Knox County Regional
Faculty also include Mike Tabor, DDS, and Richard Weems, DMD. Tabor is chief forensic odontologist for the state medical examiner for Tennessee and Davidson County in Nashville. Weems serves as chief forensic odontologist for Jefferson County, Birmingham, Alabama, and is the current president of the American Society of Forensic Odontology. Smalley says she did not aspire to be a forensic odontologist when she went to dental school, but she developed an interest in the field through exposure during her residency program. She says that she sees dental identification as a way to use her skills and expertise to help families. “I find it interesting that by using something as little and unique as a tooth, I can help families identify a loved one,” she says.
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Education
Practice Makes Perfect
Advanced Medical Simulation Textbooks, lectures and observation aren’t enough to give physicians and medical teams confidence in performing novel procedures well under pressure. As the saying goes, “Practice makes perfect.” The sophisticated simulation center at The University of Tennessee Medical Center makes that saying a reality.
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At the UT Center for Advanced Medical Simulation the goal is continual improvement in quality of patient care and safety through education, practice and assessment. All members of the healthcare team can benefit from simulation training — physicians, dentists, nurses, allied health professionals and emergency responders — at all levels, including medical students, residents and practicing physicians. Simulation can replicate almost any diagnostic or therapeutic situation, from simple IV insertions using lowfidelity task technology to complicated surgeries using interactive technologies. The UT Center for Advanced Medical Simulation is one of only 73 in the world accredited by the American College of Surgeons Accredited Educational Institutes as a level I medical simulation center. Mitchell Goldman, MD, professor and chair of Surgery (right), oversees surgical skills practice in the UT Center for Advanced Medical Simulation.
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Replicated emergency situations, including high-risk births and cardiac arrest, allow physicians to practice scenarios and assess their responses.
Simulated “patients” can be as simple as an orange, used to practice fine needle aspiration of a tumor, or as life-like as SimMan®, a full-body manikin that can become lifelike, with changing features like heart and bowel sounds, cardiac arrest, flail chest, seizures and the ability to respond to medications. One of the most important components to simulated training is the assessment of learners. Faculty review video and test results with learners to examine performance and hone specific skills. The Center for Advanced Medical Simulation offers training to physicians at all points in their careers, starting as early as medical school. In response to a national need, the center’s co-directors, Leonard Hines, MD, and Paul Huffstutter, MD, have designed a course specifically for medical students. The course allows prospective physicians to practice basic skills prior to entering residency. Students learn and practice skills that include sterile technique, basic suturing and knot tying, basic wound care, urethral and nasogastric catheter placement, thoracentesis and thoracostomy insertion, central line placement using ultrasound guidance, resuscitative principles and endoscopic
SimNewB is a neonatal patient simulator that provides multidisciplinary teams with highly sophisticated training in critical care for newborns.
skills. The course also includes literature research and communication skills necessary for effective patient handoffs and team training. The center also offers training for physicians in all specialties. For example, anesthesiology residents can practice tasks in pain management, patient monitoring and intervention. In one crisis care simulation, they must manage and recognize symptoms of anaphylactic shock. Although rare, patients may develop allergic reactions to medications during surgery requiring the anesthesiologist to follow a crisis checklist to successfully treat the patient. Skills such as critical care decisionmaking and communication are fundamentals in simulation training and the foundation for building a better team. A better team is an important component to the patient care available at The University of Tennessee Medical Center. We use a multidisciplinary approach where the patient is at the center of healthcare. Multidisciplinary
teams utilize diverse groups of medical professionals to ensure that all of the needs of the patient will be met. In a simulated surgical training setting, a group of healthcare professionals, including surgeons, anesthesiologists, residents, fellows, circulating nurses, scrub technologists, physician assistants, technicians and nurse assistants can learn to provide a comprehensive assessment of the patient’s health and well-being. Team members evaluate the patient through their individual areas of expertise and share their input with the rest of the team. The team approach promotes coordination and communication and offers the patient a one-stop effort, as opposed to many separate evaluations, interpretations and plans.
Scan code to watch videos of the simulation technology in this issue of Frontiers or visit : utmedicalcenter.org/frontiers-videos
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Education
Highest Honors From the American Association of Oral and Maxillofacial Surgeons
Eric Carlson, DMD, MD, FACS, received one of the highest national honors for oral and maxillofacial surgeons when he was honored with the American Association of Oral and Maxillofacial Surgeons (AAOMS) Presidential Achievement Award at the 96th Annual Meeting, Scientific Sessions and Exhibition. Carlson received the award for his significant, long-standing contributions to the specialty of oral and maxillofacial surgery.
Eric Carlson, DMD, MD, FACS, professor and chair, receives a Presidential Achievement Award in his field of Oral and Maxillofacial Surgery with his wife by his side.
Carlson is currently professor and Kelly L. Krahwinkel Endowed Chairman of the Department of Oral and Maxillofacial Surgery (OMFS). He directs the OMFS Residency Program and the Oral/Head and Neck Oncologic Surgery Fellowship Program. He formerly chaired the OMFS resident review committee from 2009-2013. Carlson served the Parameters of Care Committee in the AAOMS from 1992-2012 and was chair from 2007-2012. He also chaired the AAOMS Committee on Resident Duty Hours and currently chairs the Resident Surgical Log Committee. In addition to his achievements in OMFS education, he is acclaimed for his contributions to his clinical practice and research in head and neck cancer. He currently serves as the section editor for surgical oncology and reconstruction for the Journal of Oral and Maxillofacial Surgery.
Oral and maxillofacial surgeons receive training within specialties (including general surgery, trauma surgery, surgical oncology, anesthesiology, plastic surgery and emergency medicine) that focuses almost completely on bone, skin and muscle of the face, mouth, neck and jaws. Oral and maxillofacial surgeons have the knowledge and expertise to diagnose and treat a number of functional, neoplastic and esthetic conditions in this anatomical area. The AAOMS represents more than 9,000 oral and maxillofacial surgeons in the United States, supporting specialized education, research and advocacy.
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minutes with a pharmacist
Expert advice from Cassey J. Peters, PharmD, BCPS Spring is here! Along with East Tennessee’s delightful climate and blossoming trees, we may encounter the occasional spider or mosquito, or overexpose ourselves to sunshine. Spend five minutes with Cassey J. Peters to clear up some questions that come around at this time of the year about spider bites, insect repellents and sunscreens. Q: What are the types of insect repellants? Cassey J. Peters, PharmD, BCPS, is a clinical pharmacy specialist in Emergency Medicine and practices within the Emergency Department at The University of Tennessee Medical Center. She is also an assistant professor with the University of Tennessee College of Pharmacy.
Springtime Outdoor Protection Q: What are the symptoms of a spider bite that may need medical attention? A: Most spider bites are nonvenomous and can be treated at home by cleaning the area with soap and water, applying a cold compress, and utilizing oral or topical pain relievers. If possible, catch the spider for identification so appropriate treatment can be given, if needed. The two most common venomous spiders in this area are the black widow and brown recluse. Symptoms of a black widow spider bite are muscle cramps, paralysis and seizures, and the symptoms of a brown recluse spider bite are fever, blood in the urine, rash or joint pain within 48 hours of the bite. If you experience any of these symptoms after being bitten by a spider, seek medical attention.
A: Insect repellents work by disguising human odors and carbon dioxide, which attract insects. There are a few different types of insect repellents available and registered by the U.S. Environmental Protection Agency. DEET and picaridin are classified as “conventional repellents,” whereas oil of lemon, eucalyptus and IR3535 are “biopesticide repellents.” These repellents are available at most retail, discount, drug and outdoors stores, with the most common insect repellent being DEET.
Q: What are the current recommendations for the use of insect repellent? A: Insect repellents are recommended to reduce exposure to mosquito bites and prevent insect-borne illnesses, such as West Nile and Chikungunya virus. The concentration of DEET correlates to the duration of protection you will receive from application of the product. The higher the concentration, the longer the effect. If applying sunscreen and insect repellent, apply the sunscreen first. The Centers for Disease Control and Prevention do not recommend the use of pre-combined suncreen and insect repellent products, as sunscreen often needs to be applied more often.
Q: Are insect repellents safe to use on children? A: According to the American Academy of Pediatrics, DEET insect repellent is safe to use on children as young as two months of age with a maximum concentration of 30 percent. The concern with DEET use in children stems from ingestion, not topical use, and is safe and effective in preventing insect-borne diseases when used appropriately. When using on children: • Apply sparingly to exposed areas of skin • Do not apply directly to the face; rather, spray on your hands and apply to the face of the child • Once indoors, wash off the repellent Q: What does the claim of “broad spectrum” really mean in sunscreens? A: The U.S. Food and Drug Administration has recently placed new requirements on sunscreens sold over the counter to ensure safety and effectiveness as well as to provide a uniform standard for the multitude of products. For a sunscreen to be labeled as “broad spectrum,” it must pass a test demonstrating that the sunscreen offers ultraviolet A (UVA) protection equivalent to the ultraviolet B (UVB) protection. UVA radiation contributes to skin cancer, damage and aging and UVB radiation contributes to sunburns.
Because so much medical information is available through various sources, it’s important to differentiate fact from fiction. “5 Minutes With a Pharmacist” provides clear advice about medication to the people of East Tennessee. Spring/Summer 2015 - 27
Discovery
Healthier Moms and Babies Research Aims to Improve the Lives of Mothers During Pregnancy and Delivery
Craig Towers, MD, professor in the Obstetrics and Gynecology Division of Maternal-Fetal Medicine, has approximately 20 ongoing research projects aimed at improving the lives of mothers during pregnancy and delivery while also delivering healthier babies. Towers says he wants to find answers to questions that no one else has previously studied. “During my training, I had no interest in research at all, but then I got involved in a couple of studies that had not previously been done. My research was published and I developed a passion for investigating. I feel like there needs to be more advocacy for women, especially moms and babies,” says Towers. One study Towers is currently leading involves parabens — preservatives often found in cosmetic, skin care and food products. Towers has studied 50 mothers during labor to first detect if these substances are in the mother’s bloodstream and, if so, find out whether they cross over to the baby through the placenta. Towers has found that parabens do get absorbed and also enter the fetal circulation. He said the next step is to determine if these chemicals are a risk to babies or if they are as harmless as they appear to be for adults. “I ultimately want to study what women ask all the time — can I get my hair colored or permed, or can I be in the room when my husband is painting the baby’s room?” Towers explains. “No 28 - Frontiers
one has ever studied it, so we don’t know the answers. The best way to get these answers is to first detect if these substances get into the mother’s blood. Ones that don’t are most likely safe. But if a chemical is found in the mother’s blood, the next step is to test the baby’s blood. If the substance doesn’t cross the placenta it is probably safe for the baby.
I am currently looking at fire retardants and next I’d like to study phthalates, which are also found in cosmetics.” Another current study is looking at fetal heart rate monitoring during labor. A baby’s heart rate is typically monitored through the use of a belt that the mom wears during labor. The mother’s heart rate is usually lower, fewer than 100
beats per minute, while the baby’s heart rate is typically above 110. However, if the mom’s heart rate rises above 100, this can be problematic in knowing if the monitor is detecting the baby’s heart rate or the mother’s. For this study, Towers collected data from 1,100 women in labor to see how often a mother’s heart rate rose above 100 beats per minute. His preliminary data shows that as many as 15 to 20 percent of moms had a heart rate over 100, some as high as 140 or 150. Towers hopes to have the data analyzed this summer and include a recommendation that different monitoring methods be used if the maternal heart rate goes above 100 beats per minute. Towers is also studying the side effects of the Tdap vaccine. Due to the recent rise in whooping cough the Advisory Committee on Immunization Practices recommends that pregnant women receive a Tdap vaccine with every pregnancy. Tdap is a combination of three vaccines that combat tetanus, diphtheria and pertussis. These three vaccines are all safe for pregnant women because none of them contain live viruses. Towers hypothesizes that the side effects, including sore arms and fevers, of the tetanus and diphtheria vaccines are more bothersome than pertussis alone. He hopes to advocate for a pertussis-only vaccine to become available.
The Race to Image Amyloidosis Initiating a Clinical Trial
There are approximately 30 diseases that are associated with the buildup of amyloid, fibrils made up of misfolded proteins, in various body organs. Most widely known and studied is amyloid found in the brains of patients with Alzheimer’s disease; but, less commonly, amyloid can also deposit in the heart, liver, kidneys and other organs in certain patients with multiple myeloma or light chain amyloidosis. These rarer forms of amyloid disease are difficult to diagnose early because the vast array of symptoms are often unrecognized as amyloidosis. Currently, there is no approved method in the United States for imaging the disease in patients, something that would aid in definitive diagnosis and assist physicians in monitoring patients with these devastating, often fatal disorders. To address this clinical problem, researchers in the Amyloidosis and Cancer Theranostics Program (ACTP) and Molecular Imaging and Translational Program (MITRP) have been developing new tools and techniques, through partnerships with Oak Ridge National Laboratory and Siemens, to effectively image amyloid in the body organs using radioactive proteins. The most important step of this new technique is to perform a phase I clinical trial with patients suffering from these disorders. Preparation for the clinical trial involves performing standard toxicology studies, manufacturing sufficient protein for the
The Amyloidosis and Cancer Theranostics program team created an amyloid-targeting agent called peptide p5+14.
trial, and applying for approval from the Food and Drug Administration (FDA). The ACTP team has been awarded funding and support from the Science Moving towArds Research Translation and Therapy (SMARTT) Program to help make the clinical trial a reality. The SMARTT program, available through the National Heart, Lung and Blood Institute at the National Institutes of Health, is designed to accelerate translation of research from bench to bedside. To accomplish this mission, the SMARTT program provides
regulatory support, manufacturing and toxicology services to qualified projects. The ACTP team - in collaboration with the SMARTT program, MITRP and oncologists Ronald Lands, MD, associate professor, David Aljadir, MD; and John Bell, MD, professor - is applying to the FDA for approval of an imaging clinical trial using a novel amyloid-targeting agent called peptide p5+14. SMARTT will also provide more than 500 patient doses of the peptide in preparation for the clinical trial at The University of Tennessee Medical Center.
Peptide p5+14, shown in red, is a peptide developed by the Amyloidosis and Cancer Theranostics Program team to specifically seek amyloid, shown in blue. When the peptide is radioactive it will provide a new method to effectively image amyloid in patients. A clinical trial is the next step to prove that peptide imaging of amyloid will be successful.
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Discovery
CLINICAL 101
TRIALS Shedding light on the purpose and practice of conducting clinical trials
Since ancient times, physicians have studied medical treatments by observing them on patients. Persian physician Avicenna laid the first ground rules for medical trials in his 1025 Canon of Medicine. Scottish physician James Lind is credited with the first proper clinical trial, with a control group, in the mid-1700s; he studied the prevention of scurvy by administering different dietary supplements to groups of sailors. The first modern trials began in the 1920s with Sir Ronald Fisher’s principals of experimental design. Today bringing a single new drug to market takes about a decade and costs hundreds of millions of dollars. Clinical trials are crucial in testing whether new drugs and procedures — or new uses for old ones — are effective. Since advancing research and clinical trials are cornerstones of The University of Tennessee Medical Center’s mission, it’s important to understand what they are and why we think they are so important to patients and the community. 30 - Frontiers
What is a Clinical Trial?
A clinical trial is a formal scientific study that tests new drugs, diagnostic procedures, therapies or preventative measures in groups of patients to answer specific questions about how the treatment works. A successful clinical trial hopes to show some improvement in a patient’s quality of life or offer a lower cost of treatment. Scientists first test a new treatment in the lab in test tubes and then later in models with genetic blueprints similar to humans. If those trials are successful, scientists may receive permission to test with human volunteers. During this phase, researchers begin a formal exchange of information with the National Institutes of Health (NIH) and other groups, such as the Food and Drug Administration, who help guide the study. Scientists submit a trial protocol, or plan of action, to an oversight committee called an institutional review board. This board verifies that the trial is ethical, meets the medical objectives
and conforms to the law. Researchers must follow a careful set of guidelines for choosing patient volunteers and provide all the necessary information for each volunteer to make an informed decision about participating. Trials are expensive and usually receive funding from individual donors or physicians, medical centers, foundations, pharmaceutical companies or governmental agencies such as NIH or the Department of Veterans Affairs.
Why Do We Participate in Clinical Trials?
The medical center engages in national studies through our Office of Clinical Trials, supporting our mission to advance medicine through discovery. These trials not only add to the body of medical knowledge but also they bring new treatments to the community as a whole. We currently participate in 65 clinical trials focused on improved outcomes in critical areas such as oncology; cognitive disorders such as Alzheimer’s, multiple sclerosis, Parkinson’s and stroke; and other devastating diseases in our patient population.
Become a Volunteer
Individuals often volunteer for a clinical trial to help advance medical science or as a result of suffering from a disease with insufficient treatment options. During the trial the participant can expect high-quality, study-related medical care, as well as receiving drugs or treatment that might be currently unavailable to the public. Each clinical trial has its own strict criteria for choosing volunteers. To see if you qualify for one of our currently enrolling research studies, call 865-305-9100 or 865-305-9356.
10
YEARS
Average number of years before a new drug is approved
$500-$800 MILLION
Average cost of new drug development
MORE THAN
15,000 Number of clinical trials
active at any one time on a global basis
1/100 Trials currently under way at the medical center study medications and new technologies for a broad scope of conditions and uses including: • Alpha 1 antitrypsin deficiency • Alzheimer’s disease • Breast cancer metastasis • Heart valve disease • Huntington’s disease • Molecular, cellular and tissue engineering
• Multiple Sclerosis • Orthopaedic bioengineering • Parkinson’s Disease • Peripheral vascular disease • Stroke
Number of trials that make it to approval
CLINICAL TRIAL
FACTS
From lab to pharmacy
Spring/Summer 2015 - 31
Discovery
E H T G N I T A G I T S F E V O E IN R U T C U STR
N I T G IN
T N HU
Huntington’s disease, an incurable, neurodegenerative disorder, starts as a genetic mutation that leads to an overabundance of huntingtin protein fragments, which form clumps in the brain. The defective protein is a dominant trait, so anyone who inherits the gene will eventually develop the disease. While the gene’s normal function is unknown, defective huntingtin protein leads to movement, cognitive and psychiatric disorders.
The study’s results showed key differences in the ways mutant and normal huntingtin proteins take shape.
Valerie Berthelier, Ph.D., assistant professor and director of Conformational Diseases and Therapeutics Research, is co-leading a study with Chris Stanley, Ph.D., U.S. Department of Energy’s Oak Ridge National Laboratory (ORNL), to compare the normal and pathological structures of the huntingtin protein. Neutron scattering research has revealed clear structural differences in the normal and mutated forms of the protein. “This was the very first step — the hope is that we do this basic research to shed light on the structures of the protein,” Berthelier says. “If we can start identifying any of these structures as toxic or potentially toxic, and then think about how drugs could interact with them, we might be getting to the point of rationally designing therapeutics that would target those specific structures.” The researchers conducted a side-by-side study of model protein systems in solution using a time-resolved, small-angle, neutron-scattering technique at ORNL’s High Flux Isotope Reactor. The use of neutrons, a non-damaging but highly penetrating particle, allowed the team to study the biological materials over time without degrading the samples’ structural integrity. “We compared the normal and disease versions of the protein to see how they change over time,” Stanley says. “You can see there’s a discrepancy all the way from the early stages to the end-state fibrils.”
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N I E T O
PR
The study’s results showed key differences in the ways mutant and normal huntingtin proteins take shape. The disease protein, for instance, initially forms aggregates of one to two peptides, whereas the normal version forms a bigger mass, gathering seven or eight peptides together. Data on the very early stages of protein aggregate formation supports a growing focus of the research in the amyloid field. Amyloid disorders, such as Parkinson’s, Alzheimer’s and Huntington’s, all involve protein aggregation phenomena leading to a disease. The research team claims there is no strong correlation between the amount of protein in the brain and the severity of symptoms, so they think something happens at the earliest stage of protein formation that causes its toxicity. Their continuing research aims to obtain higher-resolution structural data and refine their understanding of the huntingtin protein. Their research, “Investigating the Structural Impact of the Glutamine Repeat in Huntingtin Assembly,” is published in Biophysical Journal. Co-authors are Helen McWilliamsKoeppen, Erica Rowe Christopher S. Stanley and Tatiana Perevozchikova. Berthelier started her career studying Alzheimer’s disease, another amyloid-like disorder. She quickly started investigating the aggregation phenomena associated with Huntington’s disease. While the normal protein contains a repeat of 36 glutamines or less in its sequence, the presence of additional glutamines renders the protein “sick.”
Valerie Berthelier, Ph.D., assistant professor and director of Conformational Diseases and Therapeutics Research, is working with Oak Ridge National Laboratory to compare the normal and defective structures of the huntingtin protein.
“I became fascinated by the fact that only one more glutamine in the huntingtin protein was sufficient to initiate the disease,” says Berthelier. “I also had the opportunity to meet with and talk to patients, impressing upon me the importance of finding a treatment for this incurable disease.” Berthelier has been working on this disease for 15 years with the long-term goal of finding a cure.
Spring/Summer 2015 - 33 Spring 2015 - 29
Discovery
Searching for an Answer to Benefit
I
COPD
Sufferers
Chronic obstructive pulmonary disease (COPD) is a disease that impedes airflow, making it difficult to breathe.
THE
IMPACT 3rd
Leading Cause of Death in the U.S. 34 - Frontiers
It affects as many as 24 million people in the United States and is the third leading cause of death. While there is no cure to repair airways damaged by the disease, patients who adhere to a treatment plan enjoy a better quality of life. Treatments include medicines that relax the airways, delivered through either dry powder inhalers (DPIs) or nebulizers. Commonly, DPIs are used by COPD sufferers for their convenience; however, when hospitalization is required, patients are typically treated with nebulizers. Rajiv Dhand, MD, chair of Medicine and pulmonary medicine specialist, has had a long-term research interest in COPD. Working under a pharmaceutical grant, he is currently leading an investigator-initiated study to see if short-term use of nebulizers post-hospitalization has a better effect than if patients immediately return to their DPIs. Dhand suspects that patients will have better results inhaling medicine through a nebulizer
because it requires minimal training and muscular effort. COPD sufferers often have reduced muscle strength after a severe exacerbation that requires hospitalization. More effective therapy with nebulizers could result in fewer hospital readmissions for such patients. “Nebulizers are a bit more inconvenient to use than inhalers,” says Dhand. “They require a machine and a solution, and they have to be cleaned. Most patients prefer the inhaler that can be carried in their pockets. However, a nebulizer may allow for better efficacy of the treatment in patients leaving the hospital after an acute exacerbation. I hope to find out through this study.”
Today more women than men die from COPD
Patients are being identified and recruited for the investigation, which is expected to be completed by the end of the year. Assisting Dhand in the study are Lauren Davis; Sachin Amin, MD; Michael McCormack, MD; Scott Elder; Daniel Craig and Susan Browning.
IF YOU CURRENTLY SMOKE, TALK TO YOUR PHYSICIAN ABOUT A SMOKING CESSATION PROGRAM
COPD patients say the disease limits: • NORMAL PHYSICAL EXERTION - 70 PERCENT • FAMILY ACTIVITIES - 56 PERCENT • SOCIAL ACTIVITIES - 50 PERCENT • SLEEPING - 50 PERCENT
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