Volume XXVll, No. 6
The Independent Medical Business Newspaper
End-of-life decisions Technology and advance care planning By Jeffrey B. Rubins, MD, and Tomás Valdivia, MD
ealth care delivery and the educational systems that produced its providers and managers diverged during the managed care era of the 1980s
By Frank Cerra, MD
and early 1990s, with the care delivery models moving in a different direction from the way providers were educated and trained. Physician education and training continued in the Flexner model, with its physician-centric process of care and more emphasis on medical science and research than on the service and Shaping our future to page 10
PRSRT STD U.S. POSTAGE
Reconnecting physician education and clinical practice
End-of-life decisions to page 12
Detriot Lakes, MN Permit No. 2655
Shaping our future
nderstanding and enacting people’s values and preferences regarding medical care for life-limiting disease are tantamount to achieving the Institute for Healthcare Improvement’s triple aim of improved quality of care, improved experience for patients and families, and reduced unnecessary health care expenditures. Yet, despite efforts over the past decades to realize these goals, only a minority of adults have considered and indicated their wishes for end-of-life care. Less than 20 percent of adults have completed advance directives or have documented discussions about end-of-life care, and only 44 percent of people have communicated their end-of-life wishes to family members. Even when patients’ wishes are known, they are not reliably enacted when patients are hospitalized. As reported by the Agency for Healthcare Research and Quality in 2003, only 30 percent of physicians whose patients had an advance directive were aware that it existed, and in only 50 percent of cases where an advance directive existed was it used for end-of-life decisions. Not surprisingly, nearly 30 percent of all Medicare spending is for treatment during the last year of life, representing more than
NEW ICD-10 DEADLINE:
OCT 1, 2014
2014 COMPLIANCE DEADLINE FOR ICD-10 The ICD-10 transition is coming October 1, 2014. The ICD-10 transition will change every part of how you provide care, from software upgrades, to patient registration and referrals, to clinical documentation, and billing. Work with your software vendor, clearinghouse, and billing service now to ensure you are ready when the time comes. ICD-10 is closer than it seems. CMS can help. Visit the CMS website at www.cms.gov/ICD10 for resources to get your practice ready.
Official CMS Industry Resources for the ICD-10 Transition
SEPTEMBER 2013 Volume XXVII, No. 6
FEATURES Shaping our future 1 Reconnectiong physician education and clinical practice
MINNESOTA HEALTH CARE ROUNDTABLE
By Frank Cerra, MD
End-of-life decisions Technology and advance care planning
By Jeffrey B. Rubins, MD, and Tomás Valdivia, MD
PROFESSIONAL UPDATE: FORENSIC PATHOLOGY CSI Minnesota 18 By Lindsey C. Thomas, MD
UROLOGY Active surveillance
By Thomas J. Stormont, MD
Martha McCusker, MD Hennepin County Medical Center
ORTHOPEDICS Wrist injuries
NEUROSURGERY Trigeminal neuralgia 14
By Andrew W. Grande, MD, Stephen J. Haines, MD, and Irina Gutsalyuk, MS, PA-C
Advance care planning Addressing end-of-life issues Thursday, October 24, 2013 1:00 – 4:00 PM • Symphony Ballroom Downtown Mpls. Hilton and Towers
By L.T. Donovan, DO
RESEARCH The Go! study
By Lara LaCaille, PhD, Jennifer Schultz, PhD, and Ryan Goei, PhD
OTOLARYNGOLOGY Treatment of chronic sinus disease
By Michael Hopfenspirger, MD
SPECIAL FOCUS: HEALTH REFORM ACA update
By Kathi Wright, JD, Wade Hauser, and Monica Kelley, JD
What’s ahead in health reform?
Background and focus: For the majority, end-of-life is the most medically managed part of life. With it come complex issues that involve economics, ethics, politics, medical science, and more. Advances in technology are extending life expectancies and require a redefinition of the term “end-of-life.” It now entails a longer time frame than one’s final weeks or hours, and provokes debate as to when life is really over. Mechanisms exist to facilitate personal direction around this topic, but there is a need for improved coordination among the entities that provide end-of-life support.
Objectives: We will discuss the significant infrastructure that supports end-of-life care. We will examine the roles of long-term care/assisted living, palliative care, gerontology, and hospice. We will review the elements that go into creating advanced directives, including societal issues that make having them necessary, and the difficulties encountered in bringing them to their current state. We will present a potential road map to optimal utilization of end-of-life support today and how it may best be improved in the future. Panelists include:
By Donna Zimmerman
N Ed Ratner, MD, University of Minnesota Center for Bioethics N Suzanne M. Scheller, Esq., Scheller Legal Solutions, LLC N Cheryl Stephens, PhD, MBA, President, CEO, Community Health Information Collaborative
The Independent Medical Business Newspaper
N Tomás Valdivia, MD, MS, CEO, Luminat N Maggie O'Connor, M.D., Facilitator, Sacred Art of Living & Dying
Sponsors: Community Health Information Collaborative Luminat • Scheller Legal Solutions
www.mppub.com PUBLISHER Mike Starnes firstname.lastname@example.org EDITOR Donna Ahrens email@example.com ASSOCIATE EDITOR Janet Cass firstname.lastname@example.org
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Critical Access Hospitals Face Reassessment The U.S. Department of Health and Human Services (HHS) recently released a report recommending that two-thirds of hospitals in the critical access program be reevaluated. These facilities face having their designation removed and their extra cost reimbursement eliminated. Distance requirements to gain designation as a critical access hospital—a hospital must be at least 35 miles from another medical facility—were waived in 2006 for hospitals that offered services that otherwise wouldn’t be available in its region. When this exemption was removed, hospitals already in the program were allowed to keep their status. However, HHS officials say this increases government spending by an estimated $860,000 per hospital annually and costs government and Medicare beneficiaries nearly $1 billion more annually than
the law initially allowed. Currently, 79 of the nation’s 1,329 critical access hospitals are in Minnesota. Ninety percent of them fail to meet the distance requirement. Several of the Minnesota hospitals that could lose their critical access designation are affiliated with large health care systems, including Sanford Health, Essentia Health, and Mayo Clinic.
Health Care Staff Vaccination Rates Rise in Minnesota Participation in the FluSafe program increased this year, according to the Minnesota Department of Health (MDH). This is the third year the program has been in place. The intent of FluSafe is to ensure all health care staff at hospitals and nursing homes in Minnesota get vaccinated against influenza each season. Nationally, the U.S. Department of Health and Human Services has set a goal of a 90 percent
vaccination rate of health care personnel in its Healthy People 2020 objectives. Currently, national rates are estimated at 66.7 percent, according to MDH officials. MDH’s FluSafe program report showed that 219 facilities took part during the 2012–13 flu season. Of the participating facilities, 55 reached vaccination levels of at least 90 percent, 65 reached 80 percent to 89 percent, and 57 reached 70 percent to 79 percent. Of the 145 hospitals in Minnesota, 106 took part in the program, and 113 of about 375 nursing homes participated. “There were 30 facilities new to the program this year and we’re working hard with our partners to get more facilities to take action and participate,” says Kristin Ehresmann, director of Infectious Disease Epidemiology Prevention and Control at MDH. In an effort to help raise vaccination rates, facilities that are a part of the program receive access to guidance, tools, and promotional materi-
als through MDH and the Centers for Disease Control and Prevention.
Medtronic Buys Cardiocom for $200 Million As part of an effort to become a health-care service provider, Fridley-based Medtronic has purchased Chanhassen-based Cardiocom for $200 million. Cardiocom’s technology and services support remote monitoring of a range of chronic conditions, including cardiac, respiratory, and high blood pressure-related diseases. With the acquisition, Medtronic hopes to use telehealth technology to coordinate patient care from admission to follow-up visits. Cindy Resman, director of communications for Medtronic, says, “In the near term, Cardiocom will continue to operate independently as it does today, while we begin to explore opportunities for integration with current Medtronic tech-
What can YOU do for PATIENTS WITH
• Refer them to a local National Diabetes Prevention Program • Urge them to lose 7% of their body weight • Prescribe 150 minutes/week of physical activity • Ask them to eat more fruits and vegetables and less fat • Refer them to a cessation program if they smoke
Diabetes CAN be prevented or delayed with simple lifestyle changes!
Learn more about prediabetes, the NDPP and sites in Minnesota at: www.icanpreventdiabetes.org
MINNESOTA PHYSICIAN SEPTEMBER 2013
nologies and services.” Medtronic hopes to eventually provide these health care services on a global scale, according to Mike Genau, Medtronic senior vice president and president of its U.S. region. “We will be able to identify, treat, and manage patients through a continuum, regardless of where they are—hospital or home,” he says.
MDH Releases 2012 Patient Clinic Experience Survey Results were released on Aug. 14 from more than 230,000 patients surveyed regarding their health care experience at 651 primary and specialty clinics across Minnesota in 2012. A 2008 state health reform law requires clinics to report their performance on a standard set of quality measures. The nonprofit Minnesota Community Measurement partnered with the Minnesota Department of Health to collect and report data. The next report is expected in 2015. Patients rated clinics based on access to care, and interaction and communication with physicians and office staff. Twenty-six clinics scored above statistical averages in all categories. Ninety percent of patient respondents gave high marks for physician communication skills. This measure included questions concerning knowledge of patients’ medical history, ability to explain things in an understandable manner, listening skills, and whether physicians spent enough time with the patient. Ninety-two percent reported that clinic office staff were respectful and helpful. Many clinics scored lower on access to care. Patients were asked how often they were able to secure appointments when needed and how often they saw their provider within 15 minutes of a scheduled appointment. Only 60 percent of patients said they experienced top-level access to care. “Having these data be there, transparent and avail-
able, will help [patient choice] of clinics,” says Minnesota Commissioner of Health, Ed Ehlinger, MD. “For providers, this information creates a statewide benchmark that they can use to learn about their strengths and weaknesses, to help them improve the quality of care and the patient experience.” Eventually, this information will be integrated into the MNsure online health-insurance exchange system, according to officials. To see scores, visit www.mnhealthscores.com.
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Allina Study Finds Care Guides Are Effective Results from a Minnesota study published in the current issue of Annals of Internal Medicine suggest that layperson care guides may improve care for patients with chronic diseases at a relatively low cost. The study was funded by the Robina Foundation at Allina Health and led by Allina physician Richard Adair, MD, with assistance from University of Minnesota researchers. The study evaluated 2,135 patients from six primary care clinics in Minnesota. Participants were 18 to 79 years of age and had diagnoses of hypertension, diabetes, or congestive heart failure. Each patient was given information and health care goals for his or her disease, asked to work toward the goals for one year, and randomly assigned to do so with, or without, the assistance of a care guide. According to researchers, “Care guides were recruited for specific traits and competencies: an outgoing personality, the ability to engage easily with people of different ages and backgrounds, and a second language, where needed.” Guides received brief training about disease and techniques for behavior change, then met with patients on an ongoing basis to discuss health issues and goals in layperson language. Care
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American Diabetes Association EXPO Healthcare Professional Breakfast Saturday, October 12, 2013 at 7:00am Minneapolis Convention Center Meeting Room 103 DEF *Exhibitors feature the latest products, services and medications Healthcare Reform: What does this mean for Diabetes Care in MN? *Ask the Expert: Questions answered by medical professionals *Exciting speakers on diabetes topics Presentation by Manny Munson-Regala, JD, Assistant to the *Healthy Eating cooking and Active Living fitness demo’s Commissioner of the Minnesota Department of Health. *FREE health screenings *FREE Admission The Affordable Care Act will have a significant impact on access to health insurance, *For more information call1-888-DIABETES insurance consumer reforms, payment reforms, prevention activities and work force or visitLearn www.diabetes.org/minneapolisEXPO changes. how MNsure (the new Minnesota health insurance marketplace),
insurance reforms and other provisions of the Affordable Care Act will impact diabetes prevention, diagnosis and management. Objectives:
Describe the impact the Affordable Care Act will have on patients with diabetes and prediabetes. Learn about the impact of MNsure and insurance reforms on access, care delivery and prevention. Learn about diabetes prevention initiatives that could be included in future healthcare reform.
7:00 am - 8:15am Breakfast, Networking, Presentation and Discussion RSVP on-line at http://diabetesmn.wufoo.com/forms/hcp-breakfast-rsvp/ Space is limited. Please RSVP by Friday, October 4, 2013 Event is free of charge and open to all healthcare professionals to attend
CAPSULES to page 6 SEPTEMBER 2013 MINNESOTA PHYSICIAN
Capsules from page 5 guides also followed up with patients after doctor visits. Results of the study showed that, after one year, patients assigned to a care guide experienced a 30.1 percent reduction in unmet health goals, while those who were not assigned a care guide experienced a reduction of 12.6 percent.
have passed laws allowing wider distribution of naloxone, according to the Network for Public Health Law. Gavin Bart, MD, director of the Division of Addiction Medicine at Hennepin County Medical Center, says Minnesota has seen a dramatic increase in overdoses in the last seven years.
State Appeals Court Coalition Seeks Legislation to Prevent Allows Guardians to End Life Support Overdose Deaths A new ruling by the Minnesota A state coalition of doctors and public health advocates wants Minnesota legislators to consider a bill next session that would offer legal immunity to people who seek emergency services for someone suffering an overdose and would increase access to naloxone, a drug that can revive someone who has overdosed on an opiate. Fourteen states and the District of Columbia already have so-called Good Samaritan laws in place, and 16 states
Court of Appeals is a game changer for an important endof-life issue. Guardians now have the authority to disconnect a ward’s life-support systems without approval by the state. The decision will have implications for many of the more than 12,000 Minnesotans currently under guardianship. “Although courts are experienced in making reasoned and impartial decisions, doctors and medical ethics committees have
the most appropriate knowledge and expertise to evaluate the potential for a ward’s long-term recovery and quality of life and advising a guardian on end-oflife decision-making,” Judge Natalie Hudson wrote in her decision. “Imposing a requirement for additional court involvement in this process would be inconsistent with the Supreme Court’s recognition of a private, medically based model of decision-making.” Previously, the district court had ruled that guardians had the power to consent to medical treatment on behalf of those under their care, but not the authority to terminate life support. That ruling came in 2012 in the case of Jeffers Tschumy, a 57-year-old man who suffered from diabetes, effects from a stroke, and partial paralysis from a spinal infection. Tschumy had been living in a group home, under the care of a state appointed guardian, since 2008. When he choked and suffered severe brain damage in 2012, doctors said he had
little hope for recovery. He had no known family and no health care directive. The hospital filed a motion asking a judge to allow Tschumy to be removed from life support by clarifying that his guardian had the power to make the decision, or by issuing the order from the court. Life-support termination was authorized, but the guardian’s request for power as the decision-maker was denied. As a result of the ruling, when a guardian requests termination of life support, the state requires a reasonable effort be made to obtain agreement from the ward and the nearest relative, as well as a physician’s written statement that death is imminent or that initiating CPR would be medically futile or would harm the ward. The state may also request a biomedical ethics report from the hospital treating the ward. Guardians will appear before a judge, but the final decision ultimately will be their own.
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MINNESOTA PHYSICIAN SEPTEMBER 2013
Maya Babu, MD, MBA, a resident in neurosurgery at Mayo Clinic, Rochester, has been elected to the board of trustees of the American Medical Association (AMA) for a two-year term. Babu graduated from Harvard Medical School and Harvard Business School. Imtiaz Mohamed, MD, has joined the Essentia Health–Duluth Clinic’s Maya Babu, MD Digestive Health Center. He earned his medical degree from Maulana Azad Medical College in New Delhi and completed a residency in internal medicine and a fellowship in gastroenterology at Nassau County Medical Center/SUNY Stony Brook in Imtiaz Mohamed, MD East Meadow, N.Y. Most recently, Mohamed was practicing in Hayward and Rice Lake, Wis. Thomas Moraghan, MD, has joined the Essentia Health St. Joseph’s-Brainerd Clinic to provide endocrinology services. Moraghan earned his medical degree from the University of North Dakota School of Medicine in Grand Forks and served a residency in internal medicine and a fellowship in endocrinology at the Mayo Graduate School of Medicine Thomas Moraghan, MD in Rochester. Thomas Ortmeier, MD, who is board-certified in anatomic and clinical pathology, has joined Essentia Health–St. Joseph’s Medical Center in Brainerd. He earned his medical degree from the University of South Dakota School of Medicine in Vermillion and completed his residency in pathology at the same institution. Cary H. Mielke, MD, has been appointed chief of staff at Shriners Hospitals for Children–Twin Cities, where he has served as assis- Thomas Ortmeier, MD tant chief of staff since 2006. Mielke earned his medical degree from the University of Minnesota, completed an orthopedic surgery residency at Mayo Clinic in Rochester, and completed a fellowship in pediatric orthopedic surgery at the University of Utah/ Shriners Hospital for Children–Salt Lake City. John Silkensen, MD, has been named medical director of the kidney transplant program at Hennepin County Medical Center, Minneapolis. Silkensen graduated from the University of Arkansas College of Medicine, Little Rock, and completed an internal medicine residency and nephrology research fellowship at the University of Minnesota. S. Charles Schulz, MD, professor and John Silkensen, MD head of the University of Minnesota Department of Psychiatry, will receive the Stanley Dean Award for Research in Schizophrenia in 2014, awarded by the American College of Psychiatrists (ACP) to “a group or individual that has made a major contribution to the treatment of schizophrenic disorders.” The award will be presented in February 2014 at the next annual S. Charles Schulz, MD meeting of the ACP. Before coming to the university, Schulz founded the Schizophrenia Program at the Medical College of Virginia and was the medical director of the Schizophrenia Module at the University of Pittsburgh. He has contributed to the National Plan on Schizophrenia Research and, with Carol A. Tamminga, MD, of University of Texas Southwestern Medical School, cofounded the International Congress on Schizophrenia Research.
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Preparing for the end of life ■ Tell us about Hospice of the Twin Cities.
Martha McCusker, MD Hennepin County Medical Center Martha McCusker, MD, is board-certified in internal medicine, geriatrics, and hospice and palliative medicine. Her work at Hennepin County Medical Center involves caring for older adults across the spectrum of care, including those living independently, in assisted living environments, in shortterm rehabilitation, and in long-term care. She is also medical director for Hospice of the Twin Cities in Minneapolis.
those records are stored. Ideally, clinical information is portable and should be able to be accessed by caregivers from different systems as patients move about in the health care world.
Hospice of the Twin Cities is a subsidiary of Minneapolis Visiting Nurses Association. It is located in northeast Minneapolis, but serves the greater metropolitan area. It is a freestanding, non■ How do you define the term “end of life?” profit, community-based program that is not affiliEnd-of-life is such a blurry term. We doctors are ated with any particular health care system, but it notoriously bad at determining does have relationships how much time people have left. with a number of area Patients’ goals do I’m also a geriatrician, and look sources in the Twin Cities at functional decline. When peoand throughout. Hospice of change, so having ple start to lose abilities like the Twin Cities has been being able to walk about and around for over 20 years. the conversation take themselves to the bath■ As an associate medical room, etc., that’s a sign that the once isn’t the end. director for Hospice of trajectory of life is in decline. Functional status and an expecthe Twin Cities, what are tation of less than six months some of your duties? to live play a large role in determining whether or I am there to work with the team to provide the not a patient is in a time frame where hospice is best possible services for end-of-life care for an warranted. individual patient. I am not necessarily the attending physician, but I’m there as a consultant. I provide support to the primary physician with medication management, if needed, and I work with the hospice panel staff to make sure appropriate care plans are identified. I help in clarifying a patient’s limited prognosis and exact diagnosis for hospice. Patients with a life expectancy of less than six months qualify for hospice. I’m charged by Medicare to assess those patients who live longer than six months, to ensure they continue to be appropriately served by hospice. ■ Given the merits of advance care directives,
what are some of the problems with how they exist today? One of the problems is that some patients don’t have them. Nobody has really offered to talk to the patient about them. Sometimes as physicians, we wait for patients to bring it up because it’s really not fun to talk to them about what’s going to happen when they’re in the dying process. A second issue is that sometimes the advance directive is very vague. The patient may choose not to be dependent on machines if vegetative. This can be a difficult concept to apply in any specific clinical context. A directive generally can provide information in terms of how a patient thinks in absolute “yes” or “no” terms, but it’s not specific enough. Being specific can be difficult because a patient may consider 50 scenarios by which they might pass, and it might be number 93 that brings them to the hospital. The third problem is that it’s hard to find them when you need them. There’s a problem with actually passing the document from one place to another. One approach has been to try to scan them into various electronic health records, but there’s no guarantee the patient will end up at the place
MINNESOTA PHYSICIAN SEPTEMBER 2013
■ What advice would you give physicians for talk-
ing to patients about end-of-life care issues? One is that it’s important to do it because it’s the best way we can identify what’s important to a patient and honor their preferences. The earlier we learn that, the better we can incorporate it into the plan of care. Patients’ goals do change, so having the conversation once isn’t the end. I try to make it a practice to get it on the table in that first or second visit. Discussing it when it’s not a crisis moment is helpful, but certainly discuss it at a point of change for the patient—a new diagnosis or a serious illness is an opportunity. It’s important to communicate the need for an advance care directive. ■ Tell us about hospice service. Hospice is a service that is designed to provide care to a patient at the end of life, when that patient has less than six months to live. That care can be provided wherever people happen to live—in a private home, nursing home, assisted-living setting or residential hospice house. There are also care homes not affiliated with hospice programs that provide 24-hour care. This is called the “hospice benefit,” and the extra charge is usually not covered by insurance. These homes have a very therapeutic environment, but are often very expensive. Essentially, if a patient is an appropriate candidate for hospice services, it doesn’t matter where they live, hospice will go to them. ■ What are the biggest misconceptions that physi-
cians have about hospice care? When patients come to hospice, more often than not they have a relationship with a private physician. The hope is that the physician will continue to be involved because of that relationship.
■ How do you see the role of hospice grow-
Sometimes physicians don’t realize they can continue to work with their patient to the extent they choose. Hospice allows the primary care physician to stay involved with as much hands-on care as they like, while the medical director is there within some regulatory construct. The second misconception is that it’s sometimes challenging to accurately predict a six-month life expectancy. If a physician isn’t sure, he or she might not consider hospice. It’s perfectly fine for a physician to discuss an unclear diagnosis with hospice directors.
ing as time goes by? A tool called POLST, or Physician Orders for Life Sustaining Treatment, is developing. Ideally, this document should be completed in discussion with the patient, family, a nurse, and/or a social worker to discuss the patient’s preferences in terms of being kept alive by machines. Then the physician is able to translate that into a specific set of orders for certain circumstances, residing as a physician order that can be recognized across different health care settings. It’s not 100 percent guaranteed, but it’s a very big step forward in terms of having that information created ahead of time for the patient and then having it available at the time when you need it. Ideally, a paper copy is given to the patient, who would be responsible for carrying it from one place to the next. That’s not a realistic expectation, so work is being done to have access to the record in real time, when needed.
■ How do the issues of providing hospice in
outstate areas differ from providing those services in the metro area? In a rural community, hospice nurses are going to see a lot more windshield time, even though they also spend a lot of time on the road in the metropolitan area. Doctors need to have face-to-face visits with hospice patients who have been on the program for a certain period of time. If it can be face-toface via a screen, what’s so different about that than Skyping to your grandkids? Using iPads could work as well. Utilizing information technology has really become key in maximizing efficiency. From year to year, I see more people, even older people, embracing technology.
■ What are the biggest challenges that hos-
pice care faces? Are payment issues one of them? I think the Medicare payment issue is one of them. Generally, it is paid on a per diem basis regardless of the levels of work during the process. There is discussion about changing the model of care, so that rather
than having a set payment for every day, it would be larger for the first week, lesser in the middle, and larger for the last week. Another challenge in expanding the hospice program has been identifying the appropriate stage to bring the services in to patients. Hospice was originally modeled around care for cancer patients, which was a fairly predictable clinical course at the time. There was a period of time when you knew they would lose functional status, become more ill, and eventually die. That’s not true anymore because of the explosion in different cancer treatments. That particular model of care, which is normally thought to be about six months, doesn’t really even fit cancers anymore. Hospice is started too early or too late in many cases. ■ What needs to change in terms of socie-
tal perceptions of the end of life? Death is part of life. We are in a life-affirming society where people really don’t want to admit that all good things come to an end. We need to get past the mindset that doctors can fix everything and that we will all live forever. Taking away some of the clinical, sterile approach to death and addressing other spiritual, emotional, and psychological aspects are important. There’s something we call the four gifts, which is a patient saying, “I forgive you, please forgive me, I love you, and goodbye.” Simple, but very powerful.
University of Minnesota Continuing Professional Development 2013 CME Activities
Pediatric Trauma Summit November 1-2, 2013
Care Across the Continuum: A Trauma & Critical Care Conference September 27, 2013
Donald Gleason Conference on Prostate & Urologic Cancers November 8, 2013
NPHTI/Pediatric Clinical Hypnosis October 3-5, 2013
Internal Medicine Review & Update November 13-15, 2013
Twin Cities Sports Medicine October 4-5, 2013
Emerging Infections in Clinical Practice & Public Health: New Developments November 22, 2013
Maintenance of Certification in Anesthesiology (MOCA) Training October 5, 2013
2014 CME Activities
Psychiatry Review: New Directions in Diagnosis & Treatment October 7-8, 2013
Cardiac Arrhythmias April 4, 2014
Got Your Shots? 2013 Immunization Conference October 10-11, 2013 Transplant Immunosuppression 2013 October 16-19, 2013 Practical Dermatology October 25-26, 2013
ONLINE COURSES (CME credit available)
Integrated Behavioral Healthcare Conference April 25, 2014
Annual Surgery Course: Vascular Surgery May 1-2, 2014
www.cme.umn.edu/online U Global Health - 7 Modules to include Travel Medicine, Refugee & Immigrant Health U Nitrous Oxide for Pediatric Procedural Sedation U Fetal Alcohol Spectrum Disorders (FASD) - Early Identification & Intervention
Global Health Training (weekly modules) May 5-30, 2014
For a full activity listing, go to www.cmecourses.umn.edu
Midwest Cardiovascular Forum May 17-18, 2014
(All courses in the Twin Cities unless noted)
Bariatric Education Days: Decade of Bariatric Education May 21-22, 2014
Office of Continuing Medical Education 612-626-7600 or 1-800-776-8636 U email: email@example.com
Promoting a lifetime of outstanding professional practice SEPTEMBER 2013
Shaping our future from cover
care components of medicine, in the context of the existing feefor-service payment system. Managed care, in contrast, began reshaping the process of care and people’s access to it. Doctors increasingly found themselves needing additional skill and to be “trained-in” to the environment in which they were practicing. In the mid-1990s, changes in the health care marketplace, medical payment systems, and public policy began to affect both the medical education and the care delivery sectors. Changes in the marketplace included: • Decreasing access to care • Increasing cost of care • Emphasis on encounters of care and a fee-for-service reimbursement system • Non-involvement of consumers of health services • Changing demographics as the population aged, had more chronic disease and increasing demand for
• Accountability for achievacute medical services, ing improved health and lived longer outcomes for populations, • The need for a greater and quality and cost emphasis on public health of care in the process of care, e.g., • Increasing focus on prevention, wellness, endpeople, families, and of-life care, and chronic communities disease management Over time, the effects of Concomitant challenges, these changes led to these major many of them resulting from the shifts in care delivery, which have continued to the present: • Health system Medical education is integration and defining new skills, employment of providers competencies, and • A move away capabilities to be from fee-for-service to more popuaddressed in the lation-oriented systems, such as curriculum. global fees • Increased emphasis on performance, and performance measurement, of marketplace developments, were also occurring in academia. As providers and systems the cost of educating and train• Identification of major ing doctors rose dramatically, new skills for which tradimedical students started taking tionally trained providers on large amounts of debt—a were not prepared phenomenon that skewed the choice of careers toward specialties with higher reimbursements and fewer hours of work. A shortage of primary care physicians, combined with increased consumer demand for services, contributed to reduced access to care. Medical educators began hearing that the providers they were producing did not match up with the skills that were needed in clinical practice, resulting in a need for months (or years) of costly retraining in the workplace. There was no agreement on the ever-changing care delivery model and no workforce plan with which educational institutions could respond in their enrollment and teaching models. In addition, many health systems implemented their own educational and outcomes research programs, which were generally poorly connected with the health professional schools. In terms of public policy, the 2008 Minnesota Health Act and the federal Affordable Care Act, passed in 2010, have accel-
MINNESOTA PHYSICIAN SEPTEMBER 2013
erated the pace of change in the care delivery system. Health care homes, accountable care systems, and accountable care communities have been implemented, along with new incentives for aligning prevention, inpatient, and non-hospital care and payment systems. Provider and system performance based on
achieving improved efficiency, productivity, and outcomes is rapidly becoming aligned with payment systems. These disruptive energies in both the care delivery and the educational systems are significantly affecting the education and clinical readiness of physicians. Overall, we need to align the educational system producing the providers with the system within which care is delivered. The discussion below addresses three key areas where medical education is adapting to prepare medical students for the redesign of health care delivery: • The educational framework and environment • Education content • Interprofessional education and practice Educational framework and environment
Medical education is moving from a focus on medical students and educators to one that views all participants—including students, residents, faculty, practitioners, other providers, administrators—as learners with contributions to make. This reflects the shift in emphasis toward patient-centered and evidence-based care, including prevention, population health, and direct consumer engagement.
In order to produce a better match between the graduating provider and the practice environment, medical education is defining new skills, competencies, and capabilities to be addressed in the curriculum. This shift recognizes that education and practice need to reconnect, particularly in community settings, where the largest share of the training of physicians and surgeons occurs. In addition, there is growing awareness that the provider systems and the education community need to form partnerships that define the needs and then evaluate performance in the practicing community in a way that continually informs the lifelong learning process. Retraining efforts by the health systems have identified areas where graduating learners appear to be deficient, and medical schools are making progress in incorporating concepts of evidence-based care and patientcentered care into the curriculum and its learning experiences. Team competencies for interprofessional care delivery,
particularly in the area of patient safety, have been developed and are being incorporated into learning experiences at various stages of provider develop-
models are evolving. Social services are increasingly taking the lead in helping communities and families achieve health goals. Clinical pharmacy is implementing models of medication management where a Redesign of medical pharmacist may serve as a education needs to happen in provider or as part of a care conjunction with the team, depending redesign of the care model. on the setting. We need to educate physicians to work effectively with these new professionals and as productive ment, as well as into accreditaal teams designed to meet the team members. tion standards. different needs of individuals, New content is being implefamilies, and communities, Interprofessional education mented to support the essential located in diverse settings. and practice new skills in the learning and Some teams will continue to working environments. For be physician-dominant, particu- Redesign of medical education example, in recognition that larly in areas of medical diagno- needs to happen in conjunction improving health outcomes sis, complex medical managewith the redesign of the care requires that public health ment, and skilled procedural model, with both oriented become part of health care, new intervention. In other areas, toward improving health outcontent and learning experiences such as primary care, managecomes. Building new content, are providing medical students ment of chronic disease, end-of- skills, and competencies into the with a working knowledge of life care, prevention, and wellprevention, wellness, public ness, nurse clinician-centric Shaping our future to page 38 health practice and population health, and social determinants of health. Another area of increasing importance is informatics, a discipline that includes the skills of information acquisition, management, analysis, and applicaDo you have patients with trouble using tion in real-time settings so the their telephone due to hearing loss, speech right information is in the right or physical disability? place at the right time to make the right decision. These basic If so…the TED Program skills can be applied in database provides assistive telephone management to support service equipment at NO COST lines, performance and outto those who qualify. comes assessment, and coordination of complex health needs. Please contact us, Functioning as a provider or have your patients employee in an integrated health call directly, for more system requires additional skills information. in leadership, including an awareness of where one fits in the organizational structure, an 1-800-657-3663 understanding of systems of www.tedprogram.org care, and an appreciation of how to deploy the workforce in a way that creates a satisfying Duluth • Mankato • Metro work environment. New content Moorhead • St. Cloud addressing these skills will likely draw from disciplines such as The Telephone Equipment Distribution Program is funded through the behavioral economics and the Department of Commerce Telecommunications Access Minnesota (TAM) social sciences. and administered by the Minnesota Department of Human Services In the redesigned healthcare delivery system, providers will be working in new relationships with new types of providers, often in interprofession-
Telephone Equipment Distribution (TED) Program
In addition, medical education is increasingly viewed as a process of lifelong learning, in a continuum from learning institution to advanced training to continuous learning throughout practice. And that learning is no longer mainly classroom-based. The new tools of simulation, online learning, social media, and smartphones are changing the approach to learning for both providers and consumers. The physician-centric Flexner model, in which the patient/client presents with a disease that requires diagnosis and management, is transforming to a model of shared responsibility and accountability for the achievement of health goals, using interprofessional approaches and providers, in a variety of settings.
End-of-life decisions from cover
$1.65 billion in expenses that, when asked, most patients say they do not want. In response to these concerns, several states have launched initiatives or funded organizations that focus on improving communication between doctors and patients about prognosis and treatments. In addition, many medical schools and continuing medical education programs have developed training modules to help providers communicate bad news, manage transitions to palliative care, and handle requests for therapies that are likely to be futile. While important, such efforts alone will likely not be sufficient to ensure that patients receive the care they want. Although facilitated conversations are more personalized, they also are resource intensive, are difficult to extend to large populations, and introduce a great deal of variability into the final product. In addition, most of the
available paper-based health care documents direct patients to accept or refuse interventions (for example, intubation, dialysis, tube feedings) rather than to determine patients’ preferences regarding the minimal quality of life that they would find acceptable after proposed treatments. Typically, the choices about these interventions are presented in such documents in the context of extreme clinical scenarios (such as brain death, permanent coma, or impending death despite treatment), which are not typical of the clinical situations where decisions must be made in the hospital. Moreover, the individuals designated as health care agents seldom participate in these discussions. Finally, these directives are not usually accessible to providers at important junctures in health care, such as in the emergency department or mobile ICU. Using technology to improve the advance directive process
Technology increasingly is being used to improve the advanced-
MINNESOTA PHYSICIAN SEPTEMBER 2013
care planning process. On the provider side, web-based programs are improving providers’ awareness of and skill at discussing difficult decisions. Webbased video decision-support tools can help providers facilitate conversations with patients. The Advance Care Planning Decisions website (see sidebar on p. 13), produced by a nonprofit foundation, makes available a series of culturally appropriate and easy to use informational videos for providers to help patients understand the trajectory of certain diseases, including advanced dementia, cancer, and heart disease. For patients, the PREPARE website was launched this year by clinical investigators at the San Francisco VA Medical Center, UCSF, and the Veterans Health Research Institute. As reported in the November 2012 issue of the Journal of Pain and Symptom Management, the researchers studied English- and Spanish-speaking patients and surrogate decision-makers who reported having to make serious medical decisions for themselves or for loved ones. Qualitative analysis confirmed that advance directives were not sufficient to prepare patients and surrogates for medical decision-making. Many participants recognized that focusing solely on treatments, such as mechanical ventilation, was not sufficient to help with the “many decisions” which they were facing. As a result, the PREPARE tool was constructed using straightforward language, videos, concrete examples, and simple step-bystep instructions to be a patientfriendly online resource to help patients identify what is most important in their lives, to communicate that information to family/friends and doctors, and to make informed medical decisions when necessary. The website’s audio-visual interface is tailored to typically underserved populations and is written at a fifth-grade reading level. It includes voice-overs of all text, closed-captioning for the hearing impaired, and large font for the visually impaired. When completed, the program pro-
duces an Action Plan that patients can use to facilitate discussions with their family and providers. As another example, The Conversation Project website was cofounded by journalist Ellen
Less than 20 percent of adults have completed advance directives. Goodman as a national campaign to help people talk about their wishes for end-of-life care and, by normalizing these kinds of discussions, to transform our death-adverse culture. In similar fashion, Caring Connections, a project of the National Hospice and Palliative Care Organization, is an informational website with resources to encourage people to plan for their medical care before they get sick. Making Your Wishes Known: Planning Your Medical Future is an online, interactive, computerbased decision tool developed by researchers at Penn State. The website uses multimedia formats to provide tailored information and help individuals clarify their values through reflective exercises. A unique multi-attribute utility algorithm translates individual values and preferences into a detailed advance directive comprising both general and specific wishes. The program has been shown to be feasible and effective in published studies. To address the problem of having advance directives accessible when needed, several states have recently established statewide electronic registries for form-based advance directives. In addition, several stand-alone registries for advance directives are available, including the America Living Will Registry, Choices Bank, DocuBank, MyHealthDirective.com, and U.S. Living Will. Advancing technology’s promise
The examples above illustrate the promise of technology for improving the process of creat-
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Indications and Usage Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin.
Important Safety Information Liraglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® (liraglutide [rDNA origin] injection) or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and antiliraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. Please see brief summary of Prescribing Information on adjacent page.
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causal-
MINNESOTA PHYSICIAN SEPTEMBER 2013
ity could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial Placebo + Glimepiride Rosiglitazone + All Victoza® + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2
5.3 0.9 1.7 5.2 0.9 2.6 Add-on to Metformin + Glimepiride Victoza® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Victoza® 1.8 mg once daily + Exenatide 10 mcg twice daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 235 N = 232 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia: In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin,
the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to 0 0 — self−treat Patient able to self−treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Glimepiride + Placebo + Metformin Add-on to Metformin Victoza® + Metformin (N = 724) Metformin (N = 121) (N = 242) Patient not able to 0.1 (0.001) 0 0 self−treat Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) Continued Victoza® None Add-on to Victoza® + Insulin detemir + Metformin Victoza® + Metformin + Metformin alone (N = 163) (N = 158*) Patient not able to 0 0 — self−treat Patient able to self−treat 9.2 (0.29) 1.3 (0.03) — Add-on to Victoza® + Glimepiride Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) (N = 114) Glimepiride Patient not able to 0.1 (0.003) 0 0 self−treat Patient able to self−treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin Victoza® + Metformin + Rosiglitazone None + Rosiglitazone + Rosiglitazone (N = 355) (N = 175) Patient not able to 0 — 0 self−treat Patient able to self−treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + + Glimepiride + Glimepiride (N = 230) Glimepiride (N = 232) (N = 114) Patient not able to 2.2 (0.06) 0 0 self−treat Patient able to self−treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015681-1 5/2013
ccording to the Centers for Disease Control and Prevention, more than one-third of Americans are now considered obese. Efforts to prevent obesity involve changing the individual behaviors that contribute to obesity, mainly healthful eating and physical activity as well as the social and physical context in which those behaviors take place. Due to their existing networks and available resources, worksites are a logical place to help individuals make healthy choices through health promotion efforts. To address high rates of obesity among the working-age population, employers are engaging in worksite interventions. In the past 10 years, the number of employers offering wellness benefits has increased significantly. According to a 2010 survey by the Kaiser Family Foundation and the Health Research and Educational Trust, 92 percent of employers with 200 or more employees reported offering wellness programs. Within these programs, the most frequently
The Go! study A multi-component approach to improving worksite health By Lara LaCaille, PhD, Jennifer Schultz, PhD, and Ryan Goei, PhD targeted behaviors are physical activity (addressed by 63 percent of employers with programs), smoking (60 percent), and weight loss (53 percent). Employer-based wellness programs will likely increase as a result of the Affordable Care Act (ACA). Under the ACA’s provisions, employers may award employees up to 20 percent of their cost of health plan coverage for participating in wellness programs that require meeting health-related standards. The award increases to 30 percent in 2014. The purpose of our project (named the “Go!” program) was to partner with a community hospital to plan, implement, and evaluate a multi-component obesity prevention program in its
workplace. Approximately 60 percent of employees at this hospital were obese or overweight; this rate is not surprising, given the high degree of stress and time constraints health care professionals face. The prevention program targeted individual and interpersonal determinants of eating behavior and physical activity, as well as the social and physical context in which these behaviors take place. It was hypothesized that simultaneously offering individual tools, providing information and persuasive messaging, and changing the social environment would lead to healthier eating, increased physical activity, and reduced risk for obesity. The interventions included five integrated components: • Nutrition labeling in the worksite cafeteria • Physical changes to cafeteria environment • Distributing pedometers to employees • Persuasive messaging throughout employee common areas • Using peer helpers to address social norms around eating and physical activity behaviors Methods
Interventions. Nutrition labeling in the worksite cafeteria consisted of creating traffic light labels (green = go, eat frequently; yellow = caution, eat in moderate portions; red = stop, eat in small portions) on all foods and beverages based on caloric density (calories per gram of food) (see Fig. 1). Total calories and number of steps required to burn those calories were included on the color-coded label. The labels were placed prominently at the point of selection. Environmental changes in
MINNESOTA PHYSICIAN SEPTEMBER 2013
the cafeteria included rearranging the physical layout of the cafeteria (e.g., bakery case moved from central location and replaced with a healthy “graband-go” case), changing the spoon size for self-serve items, and offering half-portions for half-price. To complement the food labeling intervention (i.e., the step counts on the labels), we distributed pedometers to employees who participated in the study (i.e., those who completed the baseline survey and measurement). Research suggests that worksite walking programs using pedometers have produced increases in moderate intensity physical activity levels, improved attitudes toward physical activity, and increased motivation. A stairwell intervention and campus walking routes were developed to encourage employees to increase their physical activity. Health communication messages in the cafeteria and worksite areas were used to change employee perceptions of the risk posed by obesity, their attitudes toward eating healthfully and exercising, and their self-efficacy to engage in those recommended behaviors. Posters, table toppers, and pamphlets featured persuasive messages about healthful eating and physical activity. A website was developed that provided relevant information to improve healthful behaviors (e.g., ideas on how to eat more nutritious meals, calorie counts, recipes, walking routes, gym locations, BMI calculators, and walking journals). Another innovative feature of the Go! intervention was using social networks to influence behaviors around healthy eating and physical activity. We identified employees who were considered by their peers to be respected, socially connected, and influential. These peer helpers were members of the social network to whom other members naturally turned to for advice and support. They were trained on how to engage colleagues about healthful eating and physical activity, as well as how to change the work environ-
ment to promote healthful behaviors (e.g., promoting healthy snacks in break rooms). Study design and participation. A quasi-experimental design was used to examine the effectiveness of the Go! intervention over a 12-month period. The intervention group consisted of on-campus hospital employees, whereas the comparison group consisted of the employees who worked at off-campus satellite clinics. A survey was distributed at baseline and at six months and 12 months post-baseline. Variables of interest included the key constructs of knowledge, attitude, social norms, selfefficacy, and perceptions of risk, as well as self-reported health behaviors. In addition, demographics, readiness to change, and perceived barriers to changing health behaviors were collected. Employees who agreed to participate completed anthropometric measurement (BMI, waist circumference) at baseline, six months, and 12 months. In addition, we collect-
ed data on food purchasing from the worksite cafeteria. The comparison group also completed the surveys and the anthropometric measurements. A total of 407 hospital employees in the intervention group and 92 clinic employees in the comparison group were assessed during the course of the study (22 percent and 59 percent response rate, respectively). Of these, 278 hospital employees and 74 clinic employees completed the 12-month assessment. Fifty-one peer helpers were also engaged in the intervention.
Figure 1. Traffic lights poster at a drink vending machine in the Surgery Department
Of employees completing the baseline and final assessments (hospital n = 278; clinic n = 74), the majority were white (91.2 percent), female (85.3 percent), and married (66.5 percent). Mean age was 43.3 + 11.5 years with a BMI of 28.1 + 6.2 (64.7 percent overweight/obese). The most frequent occupations represented in the sample were nursing (33.3 percent), service (21.0 percent), and clerical (16.3 percent).
Most hospital employees (86.8 percent) reported that the interventions in the Go! program should be continued by the hospital, with slightly fewer (73.4 percent) indicating it had had an
impact on changing their behaviors. Overall, approximately 85 percent of hospital employees reported that the traffic light labels were useful, with 25.2 perThe Go! study to page 32
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SI,” “Crossing Jordan,” “Autopsy,” “Body of Proof,” “Cold Case Files,” “Rizzoli & Isles,” “NCIS,” “Dr. G: Medical Examiner”—it seems that every other show on television these days features a forensic pathologist, and it’s usually a young and glamorous woman. But what is the reality of the life of a forensic pathologist? • Opening the trunk of a car in an abandoned parking lot to find the body of a young woman who has been shot in the back. • Watching a young father lovingly place his dead baby in the medicolegal death investigator’s car for transport to the medical examiner’s office, after he fell asleep and probably rolled over on her during the night. • Explaining to a mother that her teenage son had finally taken his life after numerous previous attempts, despite her heroic efforts to save him. • Learning again and again
U P D AT E :
PAT H O L O G Y
CSI Minnesota A subspecialty that requires sharp knives, sharp minds By Lindsey C. Thomas, MD that the human capacity for cruelty is almost overwhelming, but never greater than the human capacity for kindness. As forensic pathologists, we see people at the worst time of their lives, when a loved one has died suddenly and unexpectedly, and are privileged to help them and be helped by them. Emergence of a subspecialty
Forensic pathology is a relatively new field of medicine. It was not until 1959 that the American Board of Pathology recognized forensics as a subspecialty of pathology and began a certification process. Since that time, slightly fewer than 1,500 people have become board-certified, making it one of the smallest specialties in medicine. Each year only 35–40 physicians get
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trained in forensic pathology, compared to about 15,000 who go into internal medicine. Here in Minnesota there are 19 boardcertified forensic pathologists, most of whom work in medical examiner offices. The history of death investigation is no doubt as old as human civilization, but the system we use in the United States began in England in 1194, when the Articles of Eyre established the office of coroner (from the Latin custos placitorum coronae for Keepers of the Pleas of the Crown). Initially more of a financial office, over time the coroner’s role evolved into that of death investigation. English settlers brought the office of Coroner with them to the new world. In the 1800s, in both England and parts of the United States, there was recognition of the need for a more medical approach to death investigation; this led to the birth of medical examiners. Historically, a coroner has been an elected official who may or may not have any particular training in medicolegal death investigation, whereas a medical examiner is generally understood to be a forensic pathologist who is appointed by the county board or other governing body. In Minnesota we have both coroners, who are physicians, and medical examiners, who are board-certified forensic pathologist physicians. The nuts and bolts of forensic pathology
MINNESOTA PHYSICIAN SEPTEMBER 2013
While it is different from what is presented on television, the work of a forensic pathologist is very rewarding. We get to help families find answers to explain why their loved one died suddenly and unexpectedly. We get to help the public health system to identify infectious diseases and other preventable causes of
death. We get to help the justice system to appropriately determine which deaths occurred at the hands of another person and to testify and explain to juries how those deaths happened. We get to help the public safety system by providing data that can be used to improve the safety of vehicles and roads. And we get to help the public by facilitating organ and tissue donation, determining which deaths have a genetic cause, recognizing unsafe consumer products and reporting them, detecting trends in deaths due to drug abuse, and in myriad other ways. Some of the challenges of working as a forensic pathologist are attributable to the very public nature of our work. In high-profile cases, there is a great deal of pressure to provide answers immediately. In reality, laboratory and other tests take longer than is often portrayed in the media, and this can cause frustration for all involved. In addition, data practices laws limit what information medical examiners can disclose, and this also can add to the difficulty of providing appropriate information to the public. Another stressor for forensic pathologists is the element of testifying in court. It often seems that the goal of the “other side” is to make a witness appear foolish, and such courtroom confrontations can take their toll. Finally, forensic pathologists’ almost daily exposure to violence and tragedy requires special coping skills. A common misconception is that the medical examiner is part of the law enforcement prosecution team. While medical examiners work collaboratively with those agencies, it is important that medical examiners remain independent to ensure that the public has trust in the determinations made. The Innocence Project has found that improper forensic science has been the cause of many wrongful convictions and it is important that forensic pathologists work to prevent such miscarriages of justice. There have been cases in which a forensic pathologist erroneously classified a death as a homicide, leading to the prosecution of an
innocent person. In other situations a forensic pathologist has made statements that are not scientifically supportable, concerning the nature of the injuries sustained by a decedent. It is crucial for forensic pathologists to remember that their role is not to create a story to assist any particular “side,” but rather simply to document the findings and determine whether or not
Extra-Legal, Arbitrary and Summary Executions.” The manual was published by the United Nations in 1991 and to this day remains a valuable document internationally for investigating suspicious deaths. Advances in the field
Much about forensic pathology has not changed since 1959—we still need sharp minds and sharp knives. But have Some of the challenges of working there been some important as a forensic pathologist are developattributable to the very public ments in medicolegal nature of our work. death investigation, such as the use of DNA. DNA they are consistent with the hiswas first used forensically in tory that is given. England in 1987, when a suspect Forensic pathologists also with the improbable name of have a role in human rights Mr. Pitchfork was arrested for investigations. In the late 1980s, the murder of two girls after his the group now known as The DNA was matched to samples Advocates for Human Rights collected from the victims. began working with experts, including two forensic patholoIn 1991, a 23-year-old gists in Minneapolis, to produce woman was murdered in her “The Manual on the Effective apartment in Minneapolis. The Prevention and Investigation of forensic pathologist who per-
formed her autopsy collected specimens for potential DNA testing, although at that point it had never been used in a homicide case in Minnesota. The DNA found on her body was matched by a “cold hit” to DNA that had been taken from a convicted sex offender before he left prison earlier in 1991. (A “cold hit” is when a DNA profile obtained from a victim or scene is matched to a DNA profile in a DNA database, rather than one obtained directly from a suspect.) Previously, he had not been connected in any way to her death. If the forensic pathologist had not collected that specimen, he probably would never have been charged with her murder. Who knows how many other young women he might have killed had he not been stopped? This was the first time in the U.S. that DNA had been used in this way—all beginning with the astute forensic pathologist! Another advance in forensic pathology is the use of postmortem medical imaging, such as 3-D computed tomography
(CT) scans or magnetic resonance imaging (MRI). This is sometimes referred to as “virtual autopsy.” While these high-tech images provide many advantages as an adjunct to autopsies, they will never replace a complete hands-on autopsy. And, unfortunately, due to the high costs of the instruments, very few medical examiner offices in the U.S. have ready access to such imaging techniques. This is an area of interest and research for the future. While not all forensic pathologists wear high heels and lowcut blouses, almost all of us have a real passion for our work, just like our TV counterparts. We believe that what we are doing matters, which at the end of the day is what everyone wants—to feel our precious time is being spent on something of value and that we are making a difference in the world. Lindsey C. Thomas, MD, is a boardcertified forensic pathologist and an assistant medical examiner in the Hennepin County Medical Examiner’s Office, serving Hennepin, Dakota, and Scott counties.
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ome of the highest profile elements of the Affordable Care Act (ACA) are scheduled to take effect between this fall and 2015. These include new notice and health insurance coverage-offering requirements for employers; the requirement that nearly everyone obtain health insurance; and the end to preexisting condition limitations for everyone. In addition, states will begin to operate health insurance exchanges (the federal government will run exchanges in non-participating states) and will receive funding to expand Medicaid. Minnesotaâ&#x20AC;&#x2122;s physicians are likely aware of these changes. However, they may be less confident about their knowledge of how the ACA will affect their roles as employers and employees. This article focuses on a few ACA components that employers must address in 2014. Each of these arises from the basic requirement that employers with 50 or more full-time workers must either provide insurance coverage to fulltime employees or pay a penalty for not offering coverage.
H E A LT H
ACA update Providers are subject to employer requirements, too By Kathi Wright, JD, Wade Hauser, and Monica Kelley, JD
Prepare for play-or-play
One of the ACAâ&#x20AC;&#x2122;s central requirementsâ&#x20AC;&#x201D;sometimes called â&#x20AC;&#x153;playor-payâ&#x20AC;?â&#x20AC;&#x201D;requires that employers with 50 or more full-time (30 hours per week) employees, or full-time equivalents, must pay a penalty if they do not offer group health coverage to fulltime employees and their dependents. The statute considers children, but not spouses, to be dependents. Play-or-pay was supposed to start in 2014; however, on July 2 of this year, the federal government announced a one-year delay. The delay gives the government more time to implement reporting requirements and gives employers more time to determine which employees must be offered benefits and how best to satisfy report-
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MINNESOTA PHYSICIAN SEPTEMBER 2013
ing requirements. In 2015, employers who fail to offer qualifying coverage must pay a penalty if an employee receives subsidized coverage from the exchange (now called the â&#x20AC;&#x153;Health Insurance Marketplaceâ&#x20AC;?). Individuals whose incomes are between
providing coverage. Employers should continue to develop systems to determine which employees must be offered coverage. Part-time, variable-hour, and seasonal employees will pose challenges in making this determination. An IRS-approved â&#x20AC;&#x153;look-backâ&#x20AC;? method allows employers time to determine whether employees work full time before being required to offer coverage. Hours worked in 2013â&#x20AC;&#x201C;2014 must be tracked to determine who is eligible in 2015. This may require employers to begin to measure employeesâ&#x20AC;&#x2122; hours immediately. Employers should
Provider organizations need to be assessing ACA compliance from many different perspectives, based on the various roles the organization plays. 100 and 400 percent of the fed-eral poverty guidelines are eligible for subsidies. In participating states like Minnesota, individuals with income below 138 percent of the poverty guideline are eligible for Medicaid rather than a subsidy. Accordingly, very low-income and relatively high-income individuals are not subsidy-eligible, and employers will not pay a penalty if these employees obtain coverage subsidies from the Marketplace. The penalty amount depends on whether the employer fails to offer coverage or whether it offers coverage that is not ACA compliant. Employers failing to offer coverage will pay a penalty based on the employerâ&#x20AC;&#x2122;s total number of employees (even if only one employee obtains a subsidy). Employers offering non-compliant coverage will pay a penalty based on the number of employees actually receiving subsidies. In addition to the size of the penalty, when determining whether to provide coverage, employers should remember that they cannot take a tax deduction for the penalty, but they can continue to take a tax deduction for the cost of
also monitor guidance from the federal departments of Labor and Treasury. Notify employees of the Health Insurance Marketplace
The â&#x20AC;&#x153;exchange noticeâ&#x20AC;? requirement requires action now. In October 2013, the state or federal government will open a Health Insurance Marketplace in each state. In Minnesota, the state will operate its MNsure health insurance exchange. At least three months prior to operationâ&#x20AC;&#x201D;meaning by Oct. 1, 2013â&#x20AC;&#x201D;employers must notify employees of their option to obtain coverage through the Marketplace. Many small employers that need not offer insurance coverage still must distribute the notice, as all employers that are subject to the Fair Labor Standards Act (which generally includes all employers with annual revenues over $500,000) must send the notice. Moreover, the ACA generally requires employers to provide coverage for full-time employees only. Nevertheless, employers must notify all current employees of their option to obtain coverage through the Marketplace. After
providing the initial notice this October, employers need to provide the notice to all new employees within two weeks of their start date. In addition to explaining the existence of the Marketplace and the services it provides, the notice must tell employees whether the employer offers coverage, and must indicate whether the employer’s coverage meets the ACA’s minimum value and affordability requirements. The notice must further inform employees that if their employer’s plan does not meet the ACA’s requirements, the employees may be eligible for subsidized coverage through the Marketplace, but if they receive coverage through the Marketplace, they may lose any contribution their employer would have made to their cost of obtaining health insurance. Finally, the notice must inform employees that they can exclude the value of employer contributions to their health insurance premiums from their taxable income. The Department of Labor (DOL) has created model notices to help employers comply with these requirements and to ensure that the notice helps employees assess their options. • The model notice for employers offering coverage may be viewed at www.dol.gov/ebsa/pdf/FLS Awithplans.pdf. • The model notice for employers that do not offer coverage may be viewed at www.dol.gov/ebsa/pdf/FLS Awithoutplans.pdf. In sum, employers must take several steps to comply with the notice requirement: • First, employers must determine which employees are eligible for coverage. • Second, employers should consult their insurance providers or third-party administrators to determine whether their coverage meets the ACA’s minimum-value requirements. • Third, employers should determine the cost of a premium for employee-
only coverage (meaning it does not include dependents); this will allow employers to assess whether their coverage meets the ACA’s affordabil-
the months in which each employee received coverage that complies with the ACA. Employers must provide employees with similar information. The report to employees
By Oct. 1, 2013, employers must notify employees of their option to obtain coverage through the Health Insurance Marketplace. ity requirements. • Fourth, employers should compose the notice (or use the DOL model) and send it to employees. Keep careful records for the coming reporting requirement
The ACA requires employers to provide full-time employees, and the IRS, with certain information regarding insurance coverage provided during the previous year. Given the one-year delay, employers do not need to provide this information until Jan. 31, 2016. This delay will allow the Treasury Department to issue detailed guidance about the look-back requirement. While more guidance will be welcome, it is clear that employers must maintain careful records of the group health coverage they provide in 2015 and in future years. Employers will have to provide information to the IRS regarding whether they offered their full-time employees coverage that complies with the ACA’s minimum value and affordability requirements. The IRS report must specify the length of the waiting period before employees can obtain coverage, the monthly premium for the lowest-cost option in each of the plan’s enrollment categories, and the proportion that the employer pays of the total benefits the plan provides. In addition, the report must detail how many full-time employees the employer had during each month of the previous year and each full-time employee’s name, address, and tax identification number. Finally, the report must specify
must detail the employer’s contact information and the information that the employer provided to the IRS about the employer’s coverage. Treasury guidance is expected before the end of 2013, but even before it comes, employers can make sure they have systems in place to track the information needed to produce the reports. Consider how the Marketplace may reduce COBRA’s bite
The ACA did not make any direct changes to COBRA continuation health coverage, but
the statutes may interact in surprising ways. In general, COBRA provides that a person enrolled in a group health plan on the day of a qualifying event (such as a termination of employment or a disqualifying reduction in hours) can purchase continuing coverage from the plan for a certain period, typically 18 months. The cost of continuation coverage will very likely be higher than when he or she was enrolled in the plan because most employers do not contribute to the cost of COBRA coverage. Thus, the people most likely to take COBRA are also those who are most likely to have expensive health care needs; this is the problem of “adverse selection.” After 2014, qualifying individuals may be less likely to elect COBRA. This is because the DOL recently clarified that eligibility for COBRA does not hinder potential enrollees’ ability to obtain coverage from the Marketplace. If the potential enrollee is eligible for a subsidy, ACA update to page 36
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ealth care reform is already happening, more is on its way— and not all of it is mandated by law. In fact, we have been reforming health care in this community for decades and lead the country in areas of public health achievements, accountable care, public reporting, and high rates of private and public insurance coverage. Still, health care costs too much. On the current trajectory, by 2021 the average family in the U.S. could spend $41,868 on health care. What, then, does the Affordable Care Act (ACA) mean for the future of health care in Minnesota? Some of the most sweeping changes in the Affordable Care Act are set to take effect Jan. 1, 2014. Most changes deal with insurance reform: increasing the number of people with coverage by expanding state public programs (Medicaid and MinnesotaCare) and offering subsidies for individuals who purchase coverage for them-
H E A LT H
What’s ahead in health reform? Implications of ongoing changes in health care By Donna Zimmerman
selves and their families. Minnesota will begin operating its own health insurance exchange marketplace, MNsure, on Oct. 1, 2013. There, those who qualify as an individual or as a small employer group can enroll in state public programs and access subsidies. In addition, Minnesota will expand its Medical Assistance program (Medicaid) to cover individuals and families up to 133 percent of the federal poverty level ($15,000 for individuals, $31,000 for a family of four).
MINNESOTA PHYSICIAN SEPTEMBER 2013
The newly insured
An estimated additional 250,000 people will enter the insurance market as a result of the requirement that all Americans carry a standard
The currently insured
How will the law affect consumers who get their health coverage through their employer or who buy it on their own? Seniors on Medicare and those who obtain insurance through a large employer group will notice few changes in 2014. There are some additional benefits for Medicare, such as a preventive care visit and additional prescription drug coverage in Part D. However, many of those provisions are included in senior Medicare health plans already. People in mid-sized employer groups and in fully
The future challenge of the ACA will be to move the largest payers, Medicare and Medicaid, into the type of value-based model we’ve pioneered in Minnesota. level of medical insurance (“the individual mandate”). Coupled with this mandate is the provision known as “guaranteed issue,” under which anyone who applies for health insurance will be eligible for coverage, regardless of health condition. The vast majority of these new entrants into Minnesota’s insurance market will likely qualify for a tax subsidy or be eligible under the Medicaid expansion. This is good news for low-income citizens previously unable to qualify or afford care, as well as for the safety net pro-viders that underwrite uncompensated care. With 91 percent of Minnesotans already covered by health insurance, the state has an important opportunity to engage people who qualify for government programs but are not enrolled. They account for 60 percent of Minnesota’s uninsured population. Reaching these individuals and enrolling them will be key to our state’s success in attaining nearly universal coverage.
insured employer groups will see some new benefits added as a result of the new federally required benefit set (referred to as essential health benefits). The benefits consist of a package of services such as hospitalization and clinic care, maternity and newborn care, and prevention and wellness services. Individuals, families, and small businesses purchasing their own coverage will likely experience the most change. Today, the most popular products sold in Minnesota for individuals, families, and small groups are those that have higher deductibles, benefit flexibility, and lower monthly premiums. The ACA’s new benefits requirements and new taxes and assessments will have the most impact on those plan designs and their underlying premium structure. Subsidies will offset some of the cost of the additional benefits, and individual circumstances will vary. The good news is that individuals will have many choices
of plans, both inside and outside of the health insurance exchange. Those not accessing subsidies will have the option to purchase just as they do today from their carrier, online, or through a broker. The law also creates an obligation for employers with more than 50 full-time-equivalent employees to provide affordable insurance, or face a penalty if their employees access subsidized insurance in the exchanges. Implementation of this provision has been delayed until January 2015. Next up: payment reforms
While the ACA is currently focused on covering more people, reforms to date have not fundamentally addressed the underlying costs of health care. The ACA has created some new mechanisms, such as accountable care organizations, to introduce value-based payment (i.e., for quality rather than quantity of care) for physicians and hospitals in Medicare. These measures are designed to drive more quality, value, and accountability in the traditional Medicare program, implementing models that have emerged in health plans, hospitals, and clinics. In Minnesota, through the work of organizations such as the Institute for Clinical Systems Improvement and Minnesota Community Measurement, and through the innovations of health plans,
the quality of their care. One of these innovations, developed by HealthPartners, is a unique total cost of care measurement tool that includes total resources used in the course of providing care in addition to the costs of medical services. As we move into ACA implementation, this distinctive analysis is likely to be broadly adopted, as it more fully reflects the consumption of dollars, manpower, and resources and, thus, better illustrates where costs can be contained. HealthPartners and other organizations provide this information to health care providers to demonstrate areas of opportunity for improvement. This metric earned the first-ever endorsement by the National Quality Forum for a cost measurement approach. The tool is available free of charge to organizations around the country and is currently being used in 23 states by 65 different organizations. Most health care providers in Minnesota are well equipped to perform under new accountable models of care, with the evolution of the “health care home,” a reform championed by the Minnesota Legislature in 2008, and patient-centered care. These earlier reforms lay the foundation for the more comprehensive work underway today. For example, at HealthPartners, 75 percent of our medical reimbursements to health care
At HealthPartners, 75 percent of our medical reimbursements to health care professionals now occur on a non-fee-for-service basis.
clinics, and hospitals, we were laying the groundwork for ACA implementation long before the law was conceived. Expanding these models will do more than the ACA alone to bring down costs and improve the patient’s experience and
professionals now occur on a non-fee-for-service basis. The future challenge of the ACA will be to move the largest payers, Medicare and Medicaid, into the type of value-based model we’ve pioneered in Minnesota—a power-
ful catalyst to move further away from fee-for-service payments. We have already seen the significant benefits for patients in decreasing preventable hospital admissions/readmissions, and gains in chronic disease management, such as optimal diabetes care. A continued evolution
Creating healthy communities may be the most important long-term strategy in addressing our health care costs into the future. Real reform means forging stronger partnerships with our patients and with the communities we serve to improve health and make care more accessible with the goal of avoiding, rather than simply managing, costly chronic disease. Prevention and wellness are the best-cost medicine of all. They are also least available to the underserved populations that most need us to do what the ACA does not: improve the affordability of the system by rethinking how we deliver care. Since only 20
percent of our health outcomes are related to clinical care—with health behaviors, the socioeconomic environment, and the physical environment, accounting for the rest—we will need to work in partnership with communitybased organizations, government, and our patients and health plan members to have an impact on these variables. We know for certain that the proven methods of providing better care, improving the patient experience, and reducing costs will continue to be important in the new ACA world. We also know that we cannot continue on the path that leads to annual costs of $41,868 per family for health care and coverage. We can all agree that this is what compels us to further action in health reform. Donna Zimmerman is senior vice president for government and community relations at HealthPartners.
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The cha llen of picking ges a winner
he debate over newly diagnosed prostate cancer continues to rage with the central theme being the risk of overtreatment as a result of PSA screening. In the midst of the ongoing controversy whether and when to screen for prostate cancer, primary care physicians and their patients are caught in the middle, trying to sort through the mixed signals on PSA screening and the various provider-driven treatment recommendations once cancer is diagnosed. Often the major question many newly diagnosed men face today is not so much â&#x20AC;&#x153;What is the best treatment?â&#x20AC;? as â&#x20AC;&#x153;Is treatment even necessary?â&#x20AC;? This article provides one urologistâ&#x20AC;&#x2122;s view of two main topics: 1) the clinical significance of prostate cancer and current screening recommendations; and 2) an overview of treatment options with the focus on the hottest new treatment available: active surveillance (AS).
Active surveillance â&#x20AC;&#x153;Back to the futureâ&#x20AC;? with prostate cancer treatment Thomas J. Stormont, MD
Current prostate cancer statistics and guidelines
Prostate cancer is the second most common cause of cancerrelated death in the U.S.â&#x20AC;&#x201D; about 30,000 men die yearly, usually from painful bony metastasis. More than 220,000 men in the U.S. are diagnosed with prostate cancer each year, in part due to PSA screening. Prostate cancer is diagnosed by finding either elevated levels of PSA or a nodule on digital rectal exam (DRE), either of which can lead to transrectal ultrasound-guided biopsy (TRUSBx). Since the advent of PSA screening in the late 1980s, the lifetime risk of being diagnosed with prostate cancer has doubled to one in six. With this
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MINNESOTA PHYSICIAN SEPTEMBER 2013
increased screening has come a shift to younger age (average 67), lower stage, and aggressiveness at diagnosis, and to an increased rate of survival. The greatest survival benefit with screening and curative treatment is seen in younger men (under 70) with â&#x20AC;&#x153;higher riskâ&#x20AC;? cancers. The majority of prostate cancers diagnosed today are defined as â&#x20AC;&#x153;low riskâ&#x20AC;?â&#x20AC;&#x201D;small volume, low grade on pathologic examination, and, thus, believed to have low lethal potential. In the pre-PSA era, a smaller proportion of men were being treated with curative intent, as many otherwise died of other causes or were palliated because their cancer was found at an advanced stage. The curative treatments offered were external beam radiation therapy (RT) or open radical prostatectomy (open RP). With PSA screening, the increase in diagnoses of early prostate cancer has led to a dramatic increase in the number of men treated and an expansion in their treatment options. In addition to external beam RT and open RP, options today include brachytherapy, imageguided RT, intensity-modulated RT, Cyberknife robotic radiosurgery, robotic RP, cryoablation, and proton therapy. These newer treatments may have lower complications; however, they are often promoted despite the lack of evidence of longterm oncologic success. The increased volume of men treated for prostate cancer has helped propel prostate cancer screening into the national debate over quality of life and increasing health care costs. In 2012, the United States Preventive Services Task Force (USPSTF) recommended against PSA screening in asymptomatic
men regardless of age, suggesting that the harms of screening outweigh their benefits. Recently the American Urological Association (AUA) also issued new screening recommendations largely based upon the premise that â&#x20AC;&#x153;the decision to undergo PSA screening involves weighing the benefits of preventing prostate cancer mortality in 1 of every 1,000 men screened over a decade against the known potential harms associated with screening and treatment.â&#x20AC;? The AUA recommends that asymptomatic men 55â&#x20AC;&#x201C;69 years of age should be offered screening at least every two years. [The AUAâ&#x20AC;&#x2122;s prior recommendation was annual testing for men over 40 years of age, with no clear upper age cutoff.] It is important to note that the age cutoffs and interval of screening should be individualized and adjusted for those who have life expectancy greater than 10 years, are symptomatic (e.g., voiding problems), or are at high risk (e.g., family history, African American). This seismic shift in screening recommendations reflects the risk of overtreatment and, thus, the need for a more selective approach, with active surveillance an increasingly valid strategy in the treatment continuum. What is active surveillance?
AS is close monitoring with curative intervention if there are signs (triggers) of tumor progression. This differs from â&#x20AC;&#x153;watchful waitingâ&#x20AC;? (no intervention until signs of progression and then initiating palliative treatment). There are many AS protocols (Table 1 lists a few), with varying inclusion and monitoring criteria. All of them rely on DRE, PSA, and TRUSBx results as markers for prostate cancer monitoring. The upside of AS for the patient is obvious: maintaining the option of curative treatment, no decrease in lifespan, and preserving quality of life without the long term side effects of treatment, such as erectile dysfunction and incon-
tinence. The main downside is the concern that the tumor will progress and that the window of curability will pass. It is estimated that up to 50 percent of men with newly diagnosed prostate cancer may be candidates for AS, yet only 10 percent in the U.S. are enrolled (compared to 30 percent in Europe). Reasons cited for not implementing AS for qualified men include legal issues (litigation for undertreatment by the provider); uncertainties of predicting disease progression; economic factors (doctors/hospitals are paid to intervene); lack of patient education; dearth of long-term data; and absence of uniform AS guidelines. In addition, the emotional and physical costs to the family and patient cannot be minimized: Repeated testing can cause significant anxiety, and occasionally biopsies can lead to infection. Evidence for AS
There is growing evidence for the validity of active surveillance. Perhaps the most compelling recent study to support AS was the PIVOT (Radical Prostatectomy versus Observation in Localized Prostate Cancer) trial reported in 2012. This study involved 731 men randomized to observation versus RP, followed for 10 years. The study found no difference in mortality for those men in the low risk category. Although the PIVOT study and studies from all other institutions suffer from a dearth of long-term (decades-long) data and are based on varying protocols, in general there is excellent survival for AS patients when this option is properly chosen, and when patients are followed closely and treated with curative intent if there is disease progression. Monitoring and triggers for curative treatment
There are multiple protocols for AS, each with varying criteria for monitoring (Table 2). It is the general consensus that higher-grade cancers (Gleason score >6) or those with palpable nod-
The future of AS
1. Prostate cancer screening should be individualized. New recommendations are to offer PSA screening at least biannually to men 55–69 years of age. Timing of PSA screening should be adjusted in high-risk men, men who have voiding problems and/or if there is a >10-year life expectancy. 2. Active surveillance (AS) means to closely watch newly diagnosed prostate cancer with the intent to cure if it progresses. 3. AS appears to be a valid and safe option for some men, but more controlled and better-defined studies are needed. 4. Repeat biopsy results are the most important monitoring variable; PSA level is less accurate. 5. AS will most likely be augmented in the near future by integrating genetic testing and improved imaging (MRI). ules (T2) or higher PSA level (>10) often have poorer longterm outcomes and survival. Thus, suitable candidates for AS in general are those men considered low risk (i.e., Gleason score <6, Stage T1C with a PSA level <10). Age is a variable criterion; most protocols including any age as suitable, but some limit AS to men over 60. There are no proven treatments to inhibit progression for men on these protocols, but they often want to be proactive and thus are easy prey for supplements promoting unproven benefits. It is known that a lifestyle good for a man’s cardiovascular system is also beneficial to the prostate. And since a man is much more likely to die from cardiovascular complications than his low-risk prostate cancer, men on AS should be encouraged to lead a more heart-healthy lifestyle. Prescribing drugs in the 5-ARI class (dutasteride or finasteride) to treat AS has been proposed. REDEEM (Reduction by Dutasteride of Clinical Progression Events in Expectant Management of Prostate Cancer), a three-year study of 302 patients, showed a 40 percent reduction in progression of low-risk prostate cancer for men on AS. There are some variations in monitoring. Most protocols combine frequent DRE and PSA with an occasional TRUSBx. Triggering active treatment because of apparent tumor progression needs to be better specified within guidelines. The main trigger is usual-
ly a change in TRUSBx results; recognizing that there may be sampling variations, an increase in either volume or Gleason score usually leads to intervention. The use of PSA kinetics or density has proven the least predictive of tumor progression. Studies have shown that about 30 percent of men drop out of the AS monitoring and undergo treatment within five years, usually because of a significant change in biopsy results, PSA, or patient preference.
How AS develops as a treatment option may depend upon both education and technology. The expanding role of a shared decision-making process that includes AS as a viable option when counseling newly diagnosed men will be helpful. In addition, the accruing AS patient survival data at the multiple international study sites will further validate its role. With regard to technology, genetic biomarkers and imaging appear to hold the most promise in classifying tumor aggressiveness and predicting disease progression. The OncotypeDx Prostate cancer test (Genomic Health) and the Prolaris test (Myriad Genetics) analyze gene activity levels to generate scores that help predict both the aggressiveness and lethality of prostate cancer obtained from the TRUSBx. Imaging is another area of interest, with multiparametric MRI showing promise in helping Active surveillance to page 34
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or the 51-year-old patient who came to see me—I’ll call her Anna—the sharp, electrical-like pain that had begun shooting across her cheek was like nothing she’d ever experienced. It appeared to be arising from one of her molars and made her gasp with horror when she talked, ate, or tried to brush her teeth. Even the lightest breeze against her face could cause a terrible jolt of sensation. She had been to see a dentist, and though no decay was apparent on her X-rays, it seemed the best option to get rid of the pain was to have the tooth extracted. But the worst part was that even after the tooth had been pulled, Anna’s pain persisted. The problem, it turned out, wasn’t her tooth at all, but a disease of the facial nerve known as trigeminal neuralgia (TN). Also known in centuries-old medical literature as tic douloureux and Fothergill’s disease, TN has been described as one of the most painful in human experience. Its “lightning-like” sensations make basic facial movements excruci-
Trigeminal neuralgia Treating “the world’s worst pain” By Andrew W. Grande, MD, Stephen J. Haines, MD, and Irina Gutsalyuk, MS, PA-C
ating and cause incapacitating distress. Some patients even say the pain is so severe they have considered suicide. Unfortunately, the condition is more common than most people realize. Annually in the U.S., the American Association of Neurological Surgeons reports
Trigeminal neuralgia has been described as one of the most painful diseases in human experience. more than 150,000 new TN diagnoses are made each year. Most patients are older than 50, but some are young adults in their 20s. According to the National Institute of Neurological Disorders and Stroke, women
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tend to be affected more often than men. Specific risk factors for TN remain a mystery, though heredity can play a role, as can hypertension and multiple sclerosis. In fact, little is known about what initiates TN, or why the abnormal pain signal continues
MINNESOTA PHYSICIAN SEPTEMBER 2013
to repeat itself. What’s crucial for patients is to have the pain identified quickly as TN and to begin appropriate treatment. In the neurosurgery department at the University of Minnesota, we are currently seeing as many as four new patients a week and more than 200 cases annually. Like my patient Anna, however, nearly 30 percent of the patients have had teeth extracted before TN is considered as a possible source of the problem. The pain of TN is distinct from a toothache, presenting as a sharp, lancinating pain with an electrical shock-like quality. It often occurs in short jabs or repetitive firing, “an ice pick in the face,” and not a continuous ache. TN pain is isolated to one side of the face (although bilateral disease is encountered in 2 percent of patients and in 20 percent of those with coexisting multiple sclerosis). Importantly, most TN patients have triggers for their pain: a breeze, the patter of shower water, talking on the phone, putting on glasses, kissing, or eating certain foods, including chocolate. Because the pain is so severe, they learn to avoid these triggers, living a life of fear and avoidance. Fortunately, several effective treatments are available to relieve the pain for long stretches of time. The first step is an MRI
scan to rule out any other possible causes of compression or damage to the trigeminal nerve, such as the presence of a tumor. Many patients’ TN can be helped with an antiepileptic medication, like Tegretol (carbamazepine), on its own or in combination with other anticonvulsants. (Typically, analgesics and opioids are not helpful in addressing the flashes of recurring pain caused by TN.) When seizure medications fail to relieve the pain or gradually lose effectiveness over time, several surgical techniques are available to address the abnormal signal occurring in the nerve. The gold-standard treatment remains microvascular decompression (MVD), a surgery that alleviates TN pain by buffering the trigeminal nerve from pressure and pulsations caused by a nearby blood vessel. Developed in 1966 by neurosurgeon Peter Jannetta, MD, the technique was originally greeted with skepticism, but over decades it has consistently been shown to be an effective treatment for TN. Jannetta trained a generation of neurosurgeons (including Stephen Haines, MD, head of the University of Minnesota Department of Neurosurgery) to perform MVD, which is also known as the Jannetta procedure. The procedure begins with a small incision behind the ear. The surgeon drills a small hole in the skull, and then isolates the blood vessel that is impinging on the trigeminal nerve. Once the artery has been moved away from the nerve, a piece of Teflon felt—one-quarter of a millimeter thick—is placed between the nerve and the artery to prevent the aggravation of the nerve. Typically patients stay in the ICU overnight, and then recuperate in the hospital for a day or two. Success rates for the procedure are as high as 95 percent. In the past, neurosurgeons steered away from MVD when treating patients older than 65, but a recent study in the Journal of Neurosurgery showed that, in experienced hands, even patients over 75 years of age fare well and that complication rates are no higher than for any other
general surgical procedure. For patients who may have trouble tolerating surgery, or for those who undergo MVD and have a recurrence (10 percent at 15 years), percutaneous radiofrequency rhizotomy can be a preferable solution. In the percutaneous approach, the neurosurgeon inserts a cannula through a hole, the foramen ovale at the base of the skull. An electrode threaded through the cannula can be directed to one of the three branches of the trigeminal nerve: the ophthalmic (known as V1), the maxillary (V2), or the mandibular (V3) division. The patient is then roused from anesthesia. Following momentary stimulations of an electrode, the patient can affirm whether the pain location mimics the day-to-day TN syndrome. Then the patient is put under anesthesia again, as radiofrequency stimulation from the electrode heats and injures the aggravated branch of the nerve. The injury dulls sensation in the nerve and reduces pain. The procedure is done in approximately 30 minutes and
The gold-standard treatment remains microvascular decompression. the patient can go home the same day. This approach can offer pain relief in up to 95 percent of patients, with recurrence rates slightly higher than MVD (one study reported approximately 20 percent at 15 years). Other percutaneous procedures, done with patients under general anesthesia, use a small injection of glycerol near the trigeminal nerve ganglion, or an inflatable balloon that can crush the trigeminal nerve. Another approach is to use Gamma radiation near the brain stem where the nerve originates. Typically, Gamma radiation requires two to three months to take full effect. Studies have shown that 50 percent of people are able to stop their medication and remain free of pain. Another 25 percent may be able to control their pain by continuing to take a medication like Tegretol. The recurrence rate is approximately 50 percent at two years.
Undoubtedly, treatments will continue to improve as we learn more about what initiates TN pain. The University of Minnesota is currently developing a new Facial Pain Center to research and treat TN and syndromes like it. With the use of ultra-high resolution magnetic resonance imaging available at the university, we soon may be able to identify problems in the main tract of the trigeminal nerve—as one might peer into individual fibers of an optic cable—before the nerve branches. It is hoped that better imaging will lead to new diagnostic tools, so that we can quickly and easily locate the source of a patient’s TN. In addition, we’re hopeful that new imaging techniques ultimately will help tease out the pathophysiology of this age-old syndrome, so that we may understand more about patients who are at risk and about those who
will be helped by treatment. While TN is typically treated by either neurologists or neurosurgeons, patients frequently are seen first by their primary care physician or dentist. Because of the severity of the pain, a quick diagnosis is essential. My patient Anna ultimately was able to undergo MVD, and the terrible shock-like sensations she was experiencing resolved. With a speedy diagnosis and the appropriate TN treatment, patients suffering the world’s worst pain can find that their lives improve immensely. The three authors comprise the trigeminal team within the Department of Neurosurgery at the University of Minnesota, Minneapolis. Andrew W. Grande, MD, is an assistant professor in the Department of Neurosurgery and codirects the Earl Grande Stroke and Stem Cell Laboratory in the Stem Cell Institute at the U of M. Stephen J. Haines, MD, heads the Department of Neurosurgery, where he is a professor and holds the Lyle A. French Chair. Irina Gutsalyuk, MS, PA-C, is a physician assistant in the Facial Pain Center, and specializes in addressing the particular needs of patients with trigeminal neuralgia.
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Treatment of chronic sinus disease
sinus dilation, is rapidly becoming a favored tool in the sinus surgeonâ&#x20AC;&#x2122;s toolbox. While dilation of sinus ostia is not exactly a novel concept, its more recent development in the era of miniSupport grows for in-office mally invasive and endoscopic sinus surgery has brought it to balloon sinus dilation technology the forefront. The concept underlying this procedure moves By Michael Hopfenspirger, MD away from tissue removal and toward tissue reshaping. quality studies. Furthermore, the OTC medications, including In traditional endoscopic underlying mechanisms respondecongestants, antihistamines, sinus surgery, an obstructed sible for chronic sinusitis are not sinus may be treated with and saline lavage. For poorly well understood, and broadly responsive disease, the treatremoval of the involved tissue. effective nonsurgical therapies ments may escalate to prescripEven when focusing on maximal have not advanced beyond those tion medications. These may tissue preservation, this mentioned above. include topical steroid and antiapproach still involves a level of histamines, antibiotics (oral or tissue damage, scar formation, Surgical treatments lavage), leukotriene modifiers, and recovery time. Balloon dilaand oral steroids. In some cases, For patients not achieving a sattion procedures may approach patients may be referred to aller- isfactory degree of disease resothis same problem with dilation gy /immunology specialists for lution, surgical options typically of the sinus ostium alone, leavevaluation of atopic disease or become the next consideration. ing all structures intact. Results deficiency in the immune Surgery itself includes a wide have shown the two approaches Nonsurgical treatments response. variety of procedures. The extent to be equivalent in terms of First-line treatments for both While this treatment paraand specific type of surgery are long-term patency. recurrent acute and chronic digm holds for the majority of chosen appropriate to the severBalloon dilation technology sinusitis involve a step-wise patients, it bears mention that ity of disease and to the degree has itself undergone a series of sequence of nonsurgical therathe efficacy of most of the interlikely to provide symptom relief. innovations since its introducpies. Initial recommended treatventions for chronic sinusitis During the infancy of endo- tion in the mid-2000s (tools for ments may simply comprise cannot be supported by highscopic sinus surgery in the the procedure were approved by 1950s, procedures tended to be the FDA in 2005). Initial techrather extensive with a goal of nique protocols involved the removing large amounts of disroutine use of intraoperative eased tissue. Endoscopic sinus fluoroscopy to verify placement surgery has evolved significantof the balloon guide wire within ly and is now the standard surthe desired sinus. While this is gical approach. The contempostill an option, most surgeons rary approach aims for maxinow use a lighted guide wire to mal tissue/anatomy preservaconfirm proper placement by tion while focusing on opening observing trans-illumination â&#x20AC;&#x153;bottleneckâ&#x20AC;? areas in hopes of through neighboring tissues. encourThis may result aging the Balloon sinus dilation is in reducing return of both operative rapidly becoming a normal time and cost physiolofavored tool in the sinus while eliminatgy. This ing unnecesprocesurgeonâ&#x20AC;&#x2122;s toolbox. sary exposure THE STRENGTH TO HEAL dure has to radiation. been furPerhaps the most significant ther enhanced with the introadvance in sinus surgery since duction of highly accurate and the introduction of balloon dilasophisticated image-guidance tion is the ability to perform systems. These intraoperative Learn the latest treatments and play an important role in the care these balloon procedures in the of Soldiers and their Families. As a physician on the U.S. Army tools allow surgeons to operate surgeonâ&#x20AC;&#x2122;s office rather than an Reserve Health Care Team, youâ&#x20AC;&#x2122;ll continue to practice in your community and serve when needed. Youâ&#x20AC;&#x2122;ll work with the most in complicated scenarios with operating room. Indeed, a signifadvanced technology and distinguish yourself while working with greater confidence while icant portion of patients who dedicated professionals. Youâ&#x20AC;&#x2122;ll make a difference. achieving more thorough diswould otherwise be treated 7R OHDUQ PRUH FDOO RU YLVLW ZZZ KHDOWKFDUH JRDUP\ FRP T ease eradication and fewer under general anesthesia now ÂŠ 2010. Paid for by the United States Army. All rights reserved. complications. may never need to set foot in a The most recent developsame-day surgery center for ment in sinus surgery, balloon their sinus procedures. The new
inusitis encompasses a broad range of disease processes. General categories include acute sinusitis, recurrent acute sinusitis, and chronic sinusitis (with or without polyps). Each disease category has a unique set of potential causes and treatments. While acute sinusitis is typically a self-limiting process, the other subtypes can be quite disabling for sufferers. Recurrent acute sinusitis and chronic sinusitis affect approximately 15 percent of Americans. Those burdened with chronic sinus disease can expect an impact on their quality of life worse than that seen with sufferers of back pain, congestive heart failure, and COPD (Gliklich R. and Metson, R., Otolaryngol Head Neck Surg, 113(1), 1995).
and stand by those who stand up for me.
MINNESOTA PHYSICIAN SEPTEMBER 2013
experience will look more like the case described below. A case history
Jane Doe has a several-year history of recurrent sinus infections, suffering about four to six infections per year. While each infection is generally treated with a blend of OTC remedies and antibiotics and resolves, the problem inevitably returns and leaves her missing out on work and enjoyment. Ultimately, she is referred to an otolaryngologist. Examination reveals narrowing and inflammation within the osteomeatal complex area, where several sinuses drain. Her anatomy appears favorable, and she is eager to have something done to stop this cycle. Wanting something minimally invasive that doesn’t require general anesthesia and involves minimal recovery time, Jane opts for office-based maxillary sinus balloon dilation. While Jane reclines comfortably in a procedure chair and listens to some relaxing music, her surgeon places cottonoids saturated in topical anesthetics and decongestants in both nasal passages. After a few minutes, the cottonoids and key areas around the obstruction are injected with local anesthesia (the experience has been compared to being anesthetized for a dental procedure). The surgeon then places a slender, curved device through the narrowed opening and confirms proper placement using the lighted tip. Next, the balloon is inflated, widening the opening. Jane has been prepared to expect a mild crunching sound as this occurs, and otherwise remains comfortable. Satisfied with the result, the surgeon moves to the other sinus. Within an hour or two of arriving, Jane gets up and walks out the door. Treatment considerations
The above scenario could be modified in many different ways. All of the paranasal sinuses, with the exception of the ethmoids, can be treated in this setting using the balloon catheter. The most commonly treated sinuses are the maxillary and frontals, with one to four
Pearls • Recurrent acute sinusitis patients in addition to chronic sinusitis patients may be candidates for surgical treatment. • Many candidates for sinus surgery are candidates for balloon sinus dilation procedures. • Only local and topical anesthesia is needed for office-based balloon sinus dilation surgery. • Long-term patency for balloon sinus dilation is on par with traditional methods, and the revision rate is lower for the balloon procedure. • The balloon sinus dilation procedure may allow patients to return to work within days.
sinuses being treated in the typical visit. The ethmoid sinuses present something of a conundrum within this emerging sinus procedure landscape. Many traditional endoscopic sinus procedures involve at least an anterior ethmoidectomy, treating an area of ethmoid cells in the osteomeatal complex area. Might ethmoid disease resolve once the neighboring sinus ostia are improved, obviating the need to address this area in some cases? Data on this question likely will be emerging over the next few years. Generally, candidates for the balloon sinus dilation procedure would include sufferers of recurrent acute sinusitis (as in the example above) and some forms of chronic sinusitis. While nonsurgical options should still be explored first in these patients, the in-office nature of a balloon procedure may lend itself to treating those patients who traditionally would not (yet) be candidates for sinus surgery. While this may include patients with risk factors incompatible with general anesthesia, it may also broaden the candidate pool to those who wouldn’t otherwise be considered to have disease serious enough for traditional sinus surgery. These indications are evolving. Candidates for balloon dilation procedures also should be comfortable with the idea of being awake during their sinus procedures. A patient’s trepidation can be tempered with preprocedure anxiolytics, if desired. Finally, candidates should have favorable anatomy. Significant septal deviations, prior surgery resulting in significant scarring, or landmark confusion may be
difficult hurdles to overcome in this setting. In addition to the various factors that might steer a patient toward this procedure versus its more traditional operating room counterpart (or no procedure at all), the issue of cost will likely become more and more pertinent. With high-deductible health plans becoming more common, patients are being asked to shoulder more of their own health care costs. Price-conscious consumers may compare the typical fees associated with an operating room procedure and these office-based options. In many cases, they will discover that their out-of-pocket expenses
will be significantly lower with the in-office balloon sinus procedures. This may have the added effect of bringing into the discussion patients who would otherwise be unable to afford sinus surgery. Insurance companies are recognizing this cost savings and increasingly are including inoffice balloon sinus procedures among their covered services. As the published data accumulate in support of balloon sinus dilation, more and more otolaryngologists are embracing this technology and incorporating it into their practices. Exactly where and how these procedures should fit into the treatment algorithms will continue to be debated (and rightly so). Regardless, these procedures do add to the highly technical and less invasive sinus surgery toolbox. Michael Hopfenspirger, MD, is an otolaryngologist at Ridgeview Specialty Clinics. His special interests include medical and surgical diseases of the head and neck, including chronic ear and sinus diseases, and neck cancer and trauma.
Practice Well. Live Well.
Lake Region Healthcare is located in a magnificent, rural, and family-friendly setting in Minnesota lakes country where we aim to be the state’s preeminent regional health care partner.
Our award winning patient care and uncommon medical specialties set us apart from other regional health care groups. Lake Region’s physicians and their families also enjoy an unmatched quality of professional and personal life. Current opportunities including competitive salary and benefit packages available for BE/BC physicians are: • Dermatologist • Family Medicine • Emergency Medicine • Internal Medicine
• Orthopedic Surgeon • Pediatrics • Psychiatrist • Psychiatric NP or PA
For more information contact John D. Peterson, Physician Recruiter email@example.com (218) 736-8090
712 Cascade St. S., Fergus Falls, MN 736-8000 • (800) 439-6424
Lake Region Healthcare is an Equal Opportunity Employer. EOE
www.lrhc.org SEPTEMBER 2013
ing advance directives. However, the potential of technology to ensure that people’s values and preferences regarding medical care for life-limiting disease are enacted has not yet been realized. The ideal solution would: • Identify the population at risk (via predictive modeling) • Be deployed on a providercentric basis • Serve the needs of a diverse population rather than “one-size-fits-all” • Be scalable and efficient • Produce results that are interpretable and meaningful to providers during hospitalizations; available in the clinical workflow engines; and include robust reporting to demonstrate effectiveness A number of recent start-up companies have tackled various aspects of this type of solution. TrueNorth Healthcare is piloting a beta version of its product that is intended as an online service for patients to record their legal health-care agent and then share this information with loved ones
and health care providers. MyDirectives is a free, webbased system that allows consumers to create, update, store, and retrieve secure health care directives. The product includes the elements of a living will, a health-care power of attorney, a do-not-attempt-resuscitation form, and organ donation and autopsy preferences, and is stored in a secure database. The documents are available to patients and their providers at all times, using the government’s new Blue Button system, which provides patients with a quick and secure way to access their electronic health. The product also has a unique feature of sending a copy of the document to the designated health care agents by email and asking them to sign electronically, so as to acknowledge their awareness of the advance directives. The most recent and comprehensive product is Lumināt, designed by a Minnesota-based company. Intended for use with health systems, the product comprises four key components. The first is a predictive model
FAMILY PRACTICE w/OB Warroad, MN Roseau, MN Crookston, MN • Dedicated Team Approach • Competitive Salary & Benefits • EPIC Healthcare Information System Idylic Practice Opportunities located in family friendly communities with close access to some of Minnesota’s most beautiful lakes. Contact: Kerri Hjelmstad, Physician Recruiter Altru Health System PO Box 6003 Grand Forks, ND 58201-6003 1-800-437-5373 Fax: 701-780-6641 firstname.lastname@example.org
MINNESOTA PHYSICIAN SEPTEMBER 2013
powered by Resources data from the health Advance Care Planning Decisions: www.acpdecisions.org/ care organiPrepare: www.prepareforyourcare.org/ zation’s elecThe Conversation Project: theconversationproject.org/ tronic medCaring Connections: www.caringinfo.org/ ical record Making Your Wishes Known: Planning Your Medical Future: to engage www.makingyourwishesknown.com/ the populaTrueNorth Healthcare: truenorthhealthcare.squarespace.com/ tions most MyDirectives: www.mydirectives.com/en/ in need of an advance desired care. Lumināt is highly care plan or, regardless of need, scalable, research-based, and most open to completing one. physician-developed to ensure The second design compothat patient preferences are nent is Lumināt’s cloud-based enacted at critical junctures in technology, which helps health medical care. systems’ patients create advance A health care priority care plans that will be interpretable by and meaningful to The efforts of health-care delivproviders during hospitalizaery organizations to achieve care tions. The process combines gen- that is consistent with the triple eral education with patient aims of improving quality of videos and is designed for care, improving experience for extreme ease of use. The advance patients and families, and reduccare plan can be self-guided or, ing expenditures for medical ideally, created with the help of a care that is not desired, especifacilitator in or outside the clinially for people at or nearing end cal setting. In either approach, of life, must be facilitated. As our the planning can be done with population ages, these issues will family members in the same be priorities for our health care location or in geographically systems and for each one of us. diverse settings. The process is While technology is well designed to encourage the sharestablished in most parts of care ing of results with designated delivery systems, it has not yet health care agents and providers, achieved its potential to apply and establishes a plan for updatpeople’s values and choices for ing the plan and re-sharing on a their medical care at critical care routine basis. junctures. Now, technological Third, Lumināt will intesolutions are building on that grate the results of the advance promise in the realm of end-ofcare planning process into the life care. Using these emerging health system’s workflow manapplications, health-care delivery agement tools (usually the elecorganizations will be able to tronic medical record). Proidentify appropriate patients, viders will be able to access, engage them in documenting review, and revise with patients their wishes with research-based their advance directives using methodology, integrate their the EMR as part of their outpapreferences directly into the tient visit activities. More impor- medical care workflow, and anatantly, this accessibility will lyze their success to provide the ensure that the most recent vercare that patients want at a sion of the patient’s advance lower cost. directives is readily available Jeffrey B. Rubins, MD, practices with when they present to the emerHennepin Faculty Associates at Hennepin gency department, or if needed County Medical Center, and is a professor during their hospital course. at the University of Minnesota Medical Fourth, by synchronizing School. He is ABIM board-certified in interwith data from the health sysnal medicine, pulmonary medicine, and tem, Lumināt can report on the hospice and palliative care. Tomás effectiveness of processes for Valdivia, MD, an internist and medical developing valid advance care informaticist with 20-plus years’ executive experience in health care, is co-founder plans, enactment of those plans and CEO of Minnesota-based Lumināt and to deliver care consistent with Valquist, LLC. participants’ wishes, and the financial impact of providing
Join the top ranked clinic in the Twin Cities
St.Health Cloud VA Care System Brainerd | Montevideo | Alexandria
A leading national consumer magazine recently recognized our clinic for providing the best care in the Twin Cities based on quality and cost. We are currently seeking new physician associates in the areas of:
Opportunities for full-time and part-time staff are available in the following positions:
• Family Practice • Urgent Care We are independent physicianowned and operated primary clinic with three locations in the NW Minneapolis suburbs. Working here you will be part of an award winning team with partnership opportunities in just 2 years. We offer competitive salary and benefits. Please call to learn how you can contribute to our innovative new approaches to improving health care delivery.
Please contact or fax CV to:
Joel Sagedahl, M.D. 5700 Bottineau Blvd., Crystal, MN 55429
763-504-6600 Fax 763-504-6622
• Associate Director, Primary & Specialty Medicine (IM)
• Medical DirectorExtended Care & Rehab (Geriatrics)
• Pain Specialist
• Geriatrician/Hospice/ Palliative Care
• Internal Medicine/ Family Practice
• Urgent Care Physician (IM/FP/ER) Applicants must be BE/BC.
Fairview Health Services Opportunities to fit your life
Fairview Health Services seeks physicians to improve the health of the communities we serve. We have a variety of opportunities that allow you to focus on innovative and quality care. Be part of our nationally recognized, patient-centered, evidence-based care team. We currently have opportunities in the following areas: • Dermatology
• Internal Medicine
• Emergency Medicine • Med/Peds • Family Medicine
• General Surgery
• Geriatric Medicine
• Urgent Care
Visit fairview.org/physicians to explore our current opportunities, then apply online, call 800-842-6469 or e-mail email@example.com
US Citizenship required or candidates must have proper authorization to work in the US. Physician applicants should be BC/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction Program. Possible recruitment bonus. EEO Employer.
Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.
For more information: Visit www.USAJobs.gov or contact
Sorry, no J1 opportunities.
Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303
fairview.org/physicians TTY 612-672-7300 EEO/AA Employer
The Go! Study from page 17
cent (“regularly”) and 47.5 percent (“occasionally”) using the labels in making decisions about food. Self-reported stairwell use increased during the intervention from a rather high baseline level of 76 percent to 80 percent, 84 percent, and 77 percent at the three subsequent intervention phases (significant effect at p=.002). Statistical analyses revealed that gender and BMI were related to stair use. Females reported less stairwell use than males, and BMI was inversely associated with frequency of using the stairs. In addition, the hospital employees reported a significant increase in walking from baseline and in comparison with the clinic group. However, other selfreported physical activity and dietary intake, waist circumference, weight, and BMI measurements did not significantly differ between the groups or over time. Notably, hospital employees gained significantly less weight (mean=0.26 lb, p=.005) than is
typically found in the U.S. adult population (mean=1.8 lb), whereas the clinic employees weight gain (mean=1.56 lb, p=.81) was not significantly different than is typical. Qualitative interviews with peer helpers showed that they took on many helping roles, viewed themselves as becoming effective role models, and contributed to creating health-promoting social and environmental changes at work. Discussion
The primary goal of this intervention was to encourage employees to make modest changes in their health behaviors that would help prevent weight gain. Therefore, employees were not recruited for participation in targeted weight loss, as is often typical in randomized clinical weight-loss trials. Employees in the intervention group were able to prevent the typical annual weight gain of 1.8 pounds. The data also suggest that implementing low-impact physical activity (e.g., walking, stair
Sioux Falls VA Health Care System Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package. The VAHCS is currently recruiting for the following healthcare positions in the following location.
Sioux Falls VA HCS, SD Primary Care (Family Practice or Internal Medicine) Psychiatrist
Endocrinology Emergency Medicine Pulmonologist
Hospitalist Sioux Falls VA HCS (605) 333-6858 www.siouxfalls.va.gov
use) may be more easily incorporated into the worksite setting than more challenging behaviors of altering dietary habits and increasing more vigorous forms of physical activity. Employees expressed positive attitudes toward nutrition labeling, environmental changes, and the Go! program, and were receptive to continuation of these efforts in their worksite. Physicians can take a more active role in their workplace by promoting healthful eating and physical activity. Some suggestions: • By improving their own dietary and physical activity habits, physicians can serve as role models and informal peer helpers. • Physicians can take the initiative to work with their food service director and nutritionists to encourage healthy portion sizes, nutritious food, and caloric labeling at their worksite. Physicians can help promote balanced menus at their workplace,
aiming to increase lowenergy-density (green) foods, decrease the amount of high-energydensity (red) foods, and eliminate sugar-sweetened beverages. • Working with hospital leadership, physicians can help create a healthier worksite. Support for these kinds of worksite initiatives is growing, and so are the available online resources. A starting point for physicians wanting to get involved is the Healthier Hospitals Initiative (www.healthierhospitals.org). Lara LaCaille, PhD, and Jennifer Schultz, PhD, were co-principal investigators for the Go! program. LaCaille is an assistant professor in the Department of Psychology and Schultz is an associate professor in the Department of Economics at the University of Minnesota–Duluth. Ryan Goei, PhD, Department of Communication, is an associate professor at the University of Minnesota–Duluth.
Emergency Medicine Emergency Practice Associates has immediate full-time, part-time and locums opportunities at our sites in:
Hibbing Little Falls Park Rapids Alexandria Austin For more information contact Tina Dalton or Mike Coulter at 800-458-5003, email:
firstname.lastname@example.org or visit our website at
Applicants can apply online at www.USAJOBS.gov
Your Emergency Practice Partner 32
MINNESOTA PHYSICIAN SEPTEMBER 2013
Live in the relaxed lake country of Mille Lacs and practice medicine where you will make a difference. We’re looking for a Family Physician to join us at Mille Lacs Health System in Onamia, Minnesota. Loan forgiveness options – J-1Visas considered. Contact: Fern Gershone: email@example.com or Dr. Tom Bracken: firstname.lastname@example.org
Caring for body, mind and spirit. Onamia, MN • mlhealth.org • 877 -535-3154 7 FAMILY PHYSICIANS • 9 PAs • CRITICAL ACCESS HOSPITAL ER STAFFED 24/7 • ATTACHED GERIATRIC UNIT & LTC FACILITY • 4 CLINICS
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TABLE 1. Inclusion criteria for some AS protocols. AS Protocol
University of Toronto
University of California San Francisco
T1 or T2
<3+3 = 6
<3+3 = 6
<3+3 = 6
Gleason score** PSA density*** # Positive biopsy cores
Active surveillance from page 25 improved risk stratification.
guide biopsies, and, possibly monitor tumor progression better than the current standard of ultrasound. Both the genetic assays and MRI have limited clinical use currently because of expense and because they are not included in current AS protocols.
*Clinical stage: T1C denotes nonpalpable prostate cancer detected on PSA; T2 denotes prostate cancer with a palpable nodule. **Gleason score: The histologic appearance seen on biopsy. Prostate cancer is graded 1–5, with 5 being the most aggressive. The score is the sum of two most common grades found on biopsy. ***PSA density: PSA/prostate volume on TRUSBx. TABLE 2. Monitoring interval for some AS protocols.
University of Toronto
University of California San Francisco
3 months for 2 years, then every 6 months
6–12 months for first year, then every 3–4 yrs
TRUS only for 6–12 months, then TRUSBx for 1–2 years
A valid role for AS
There is a shift underway in prostate cancer screening— and, thus, the treatment of prostate cancer patients— toward the pre-PSA era: Less screening will lead to fewer men being treated with curative intent. The USPSTF recommendation against all prostate cancer screening has been described as a “meat cleaver” approach to reducing some of the morbidity and costs associated with prostate cancer. The AUA recognizes there remains a valid role for a more focused and personalized PSA screening through
Urologists are uniquely positioned to be the ultimate educators and advocates for our patients. With more focused use of resources, the treating physicians and our patients together can ultimately determine the best treatment possible. This includes recognizing that active surveillance—while imperfect and evolving—is a valid initial treatment option for many men with newly diagnosed prostate cancer. Thomas J. Stormont, MD, is a urologist with Stillwater Medical Group.
Trinity Health One of the region’s premier healthcare providers.
Currently Seeking BC/BE s Ambulatory Internal Medicine s General Surgery
s Psychiatry s Urology
Contact us for a complete list of openings.
Based in Minot, the trade center for Northern and Western North Dakota, Trinity Health offers the opportunity to work within a dramatically growing community that offers more than just a high quality of life. Comprised of a network of nearly 200 physicians in hospitals, clinics and nursing homes, Trinity Health hosts a Level II Trauma Center, Critical Care Helicopter Ambulance, Rehab Center, Open Heart and Lung Program, Joint Replacement Center and Cancer Care Center.
For immediate confidential consideration, or to learn more, please contact
Physicians are offered a generous guaranteed base salary. Benefits also include a health and dental plan, life and disability insurance, 401(k), 401(a), paid vacation, continuing medical education allowance and relocation assistance.
MINNESOTA PHYSICIAN SEPTEMBER 2013
Shar Grigsby Health Center - East 20 Burdick Expressway Minot ND 58702 Ph: (800) 598-1205, Ext 7860 Pager #0318 Email: email@example.com
Physician Practice Opportunities
St. Cloud/Sartell, MN We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an out-patient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals. Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal. HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and benefit package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.jobs or contact firstname.lastname@example.org. Call Diane at 952-883-5453; toll-free: 800-472-4695 x3. EOE
Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership. Currently we are seeking to add the following specialists: General Surgery
For details on these practice opportunities go to http://www.avera.org/marshall/physicians/ For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691. Dave.Dertien@avera.org Avera Marshall Regional Medical Center 300 S. Bruce St. Marshall, MN 56258
Opportunities available in the following specialties: Dermatology Olmsted Medical Center, a 150-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere. The Rochester community provides numerous cultural, educational, and recreational opportunities. Olmsted Medical Center offers a competitive salary and comprehensive benefit package.
Orthopaedic Surgery Opportunity
Pine Island Clinic
Hospitalist Rochester Hospital
Live in Beautiful Minnesota Resort Community
Advanced Wound Care Rochester Hospital
Internal Medicine Southeast Clinic
Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: email@example.com
An immediate opportunity is available for a BC/BE orthopedic surgeon in Bemidji, MN. Join three board certified orthopedic surgeons in this beautiful lakes community. Enjoy practicing in a new Orthopedic & Sport Medicine Center, opening spring 2013 and serving a region of 100,000. Live and work in a community that offers exceptional schools, a state university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a â&#x20AC;&#x153;Top Townâ&#x20AC;? by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career. To learn more about this excellent practice opportunity contact: Celia Beck, Physician Recruiter Phone: (218) 333-5056 Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org AA/EOE - Not subject to H1B Caps
Phone: 507.529.6748 Fax: 507.529.6622 EOE
ACA update from page 21
coverage from the Marketplace is likely to be cheaper than COBRA. This change in health coverage has benefits for both employers and employees. Adverse selection of COBRA raises the cost of the employer’s plan. Employers can avoid some of these costs if more COBRAeligible former enrollees obtain coverage from the Marketplace. After a qualifying event, employers must notify potential enrollees of their eligibility for COBRA. The DOL recently revised a model notice that employers can use to satisfy this requirement. The revised notice informs readers about their potential eligibility for subsidized coverage from the Marketplace. The model notice can be viewed online at www.dol.gov/ebsa/modelelectionnotice.doc. The ACA may have other implications for COBRA coverage. For example, the ACA enacted new nondiscrimination
rules that prohibit employers from providing certain health benefits solely to highly compensated individuals. DOL, the IRS, and the Department of Health and Human Services delayed implementation of the nondiscrimination rules. When the rules go into effect, however, employers may no longer be able to offer highly compensated employees severance packages that include favorable COBRA coverage. Employers should keep this in mind as they offer severance packages. The Department of Labor’s health reform website provides information on many ACA compliance issues, including COBRA, at www.dol.gov/ebsa /healthreform/. Special issues for providers as employers
Most employer ACA responsibilities are not unique to particular types of employers. However, providers should be aware of a few issues that may be more likely to arise in their role as employers.
Here to care
For example, the 50employee threshold for being subject to ACA play-or-pay requirements may affect many provider organizations, from solo practitioners to very large entities employing hundreds or thousands of people. Even provider organizations that are part of a larger entity will need to be aware of ACA compliance initiatives, because some penalties are assessed at the employer level, which may—or may not— be the provider organization if it is part of a larger controlled group entity. Another consideration is that provider organizations are gearing up for many changes under the ACA that affect the delivery of medical services. With all the changes that will occur on that front, it may be easy for them to overlook employer requirements. Provider organizations need to be assessing ACA compliance from many different perspectives, based on the various roles the organization plays.
Government agencies continue to issue regulations to implement the ACA. Keep alert for new guidance and ask for help. The DOL website www. dol.gov/ebsa/healthreform/ is a good source for updates and additional information. Employers can register to receive email updates when new information is added to the site. Another good source for general ACA information is www.healthcare.gov/. Finally, knowledgeable employee benefits attorneys can help employers comply with the ACA in the way that is best for business, employees, and patients. Kathi Wright, JD, is a principal and Monica Kelley, JD, is a senior associate in the Employee Benefits and Executive Compensation group in the law firm of Gray Plant Mooty, Minneapolis. Wade Hauser is a summer associate at Gray Plant Mooty; he is a JD candidate at the University of Iowa College of Law.
Emergency Room Physicians Looking for leisure work hours?
At Allina Health, we’re here to care, guide, inspire and comfort the millions of patients we see each year at our 90+ clinics, 11 hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefits in an environment where passionate people thrive and excel. Make a difference. Join our award-winning team. Madalyn Dosch, Physician Recruitment Services Toll-free: 1-800-248-4921 Fax: 612-262-4163 Madalyn.Dosch@allina.com
Keep alert for guidance
• Set your own hours • No contract • No obligations
Attention Physicians • Immediate openings • Casual weekend or evening shift coverage
• Choose from 12 or 24 hour shifts • Competitive rates • Paid malpractice
Great Emergency Department in Southern Minnesota
allinahealth.org/careers EOE/AA 10127 0213 ©2013 ALLINA HEALTH SYSTEM ® A TRADEMARK OF ALLINA HEALTH SYSTEM
MINNESOTA PHYSICIAN SEPTEMBER 2013
763-682-5906 • 1-800-876-7171 F-763-684-0243 firstname.lastname@example.org
Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We are seeking BC/BE fullrange family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice. For consideration, apply online at healthpartners.jobs and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact email@example.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE
The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • ENT • Family Medicine • Geriatrician/Outpatient Internal Medicine • Hospitalist • Infectious Disease
• Internal Medicine • Med/Peds Hospitalist • OB/GYN • Oncology • Orthopedic Surgery • Psychiatry
• Psychology • Pediatrics • Pulmonary/ Critical Care • Radiation Oncology • Rheumatology
For additional information, please contact:
Kari Bredberg, Physician Recruitment firstname.lastname@example.org, (320) 231-6366
healthpar tners .com
Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community
An immediate opportunity is available for a BC/BE orthopedic surgeon in Bemidji, MN. Join three board certified orthopedic surgeons in this beautiful lakes community. Enjoy practicing in a new Orthopedic & Sport Medicine Center, opening spring 2013 and serving a region of 100,000. Live and work in a community that offers exceptional schools, a state university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a “Top Town” by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career. To learn more about this excellent practice opportunity contact: Celia Beck, Physician Recruiter Phone: (218) 333-5056 Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org
Julayne Mayer, Physician Recruitment email@example.com, (320) 231-5052
Spine Surgeons, join our team and set the standards for patient care.
Orthopaedic Associates of Duluth is seeking a highly motivated passionate and experienced SPINE SURGEON to provide outstanding orthopaedic care to its patients. The successful candidate will be part of our expanding and growing, well-respected team that serves patients from Duluth to northern Minnesota. Orthopaedic Associates of Duluth is a group of nine orthopaedic surgeons that provide comprehensive orthopaedic services ranging from specialty specific exams and diagnosis to state-of-the-art inoffice MRI and imaging and surgery at their physician-owned surgery center.
Email CV to firstname.lastname@example.org or call 800-461-8843 (Sue) or 218-625-2731 (June)
AA/EOE - Not subject to H1B Caps
Shaping our future from page 11
educational model will require a new kind of partnership—one that links the education community, the practicing community, the delivery systems, and public health. The shift in education and care delivery will make use of consumer-focused models for achieving health; workforce planning; an integrated continuum of care; and communities of self-care, occurring in a full closed-loop system for continuous improvement. Along the way, stakeholders will need to share information and resources, foster public-private partnerships, develop new financial support models, and use innovative communication technologies. A major national effort to achieve these new relationships is being coordinated by the National Center for Interprofes sional Practice and Education (NCIPE). To relink education with care delivery, the center is using the core approaches of leadership, collaborative prac-
tice and system transformation, education and training, research evaluation and scholarship, and development of new and innovative models. In moving ahead, the center must also develop the data that demonstrates the value of this approach in a convincing and practical way. Models are being developed and piloted with partners across the nation, and then made available for use. At the core of the group’s mission is the development of an interprofessional nexus connecting education and clinical practice approaches in order to improve health outcomes. The goals of this realignment and integration of education and the process of care include reducing cost and adding value to the alignment, improving the quality of the user and learner experience, and sharing responsibility and accountability for achieving health outcomes. Examples of evolving nexus projects are: • Achieving specific improvements in patient safety • Preventing prediabetes
MINNESOTA PHYSICIAN SEPTEMBER 2013
from becoming clinical diabetes • Reducing the cost of retraining • Creating a communitybased primary care medical-home network within a health system • Implementing a surgical team model of operating room performance The Minnesota Nexus has been formed of public, private, and educational health leadership to bring together education and clinical practice in Minnesota’s health environment. Among the group’s priorities are developing a health workforce plan and the continuum of learning for medical professionals; establishing a partnership among the health systems and the health education institutions; and creating new sustainable models for the financial support and continued development of health initiatives. For more about the Minnesota Nexus, go to www.nexusipe.org. Redesigning and realigning medical education and clinical
practice to achieve improved health status; health quality; value-added financing; and engagement of people, families, and communities are essential for all our futures and those of our children. We must shape our future now. Frank Cerra, MD, is a professor in the Surgery Department in the University of Minnesota Medical School and an adjunct professor in the U of M School of Public Health. Cerra is emeritus senior vice president for health sciences and holds the McKnight Presidential Leadership Chair at the University of Minnesota. He is senior advisor to the director of the National Center for Interprofessional Practice and Education and also serves as its deputy director.
View your home in a new way.
The more we get together, the happier and healthier we’ll be.
At MMIC, we believe patients get the best care when doctors, staff and administrators are humming the same tune. So we put our energy into creating risk solutions that help everyone feel conﬁdent and supported. Solutions such as medical liability insurance, physician well-being, health IT support and patient safety consulting. It’s our own quiet way of revolutionizing health care. To join the Peace of Mind Movement, give us a call at 1.800.328.5532 or visit MMICgroup.com.