mn physician sept 2015

Many stakeholders were excit-ed by President Obama’s an-nouncement in January 2015

that the Administration would be allo-cating $215 million for a new Precision Medicine Initiative (PMI) designed to accelerate the introduction of individ-ually tailored medicine into patient care. Champions of genomic medicine, such as NIH director Francis Collins, MD, have been calling for investments

in the clinical implementation of genomics since the completion of the first map of the human genome in 2003. The President’s announcement suggests that political will and public acceptance are in alignment with this next phase of genomic science.

The centerpiece of the PMI is a million-person cohort study that will examine the role of genes in

Diagnosing psychiatric disorders to page 20

The Precision Medicine Initiative to page 16

Vo lum e x x Ix , N o. 6S e p t e mb e r 2015

People with psychiatric symptoms are all around us. From the disheveled old woman huddled in the corner of a shop

entrance muttering nonsense to herself, to the sad-looking teller at the bank, suffering due to psychiatric disorders is one of the most preva-lent of all public health conditions. The most re-cent Global Burden of Disease study published by the World Health Organization showed that one in four people will suffer through an episode of major depression in their lifetime, and one in 17 people are currently suffering with a major psychiatric disorder. Approxi-mately 800,000 suicides are committed each year, almost all of which are a consequence of a psychiatric disorder. Unfortunately, psychiatric disorders are highly prevalent yet often over-looked, as society turns away from people with the stigma of a psychiatric illness.

Currently, psychiatric disorders are diag-nosed and treated purely based on clinical history obtained over time. Medications are chosen based on symptoms, but in many cases the medications are only partially effective, or have side effects that become intolerable.

Diagnosing psychiatric disorders

Can magnetic resonance-based tools help?

By John D. Port, MD, PhD

The Precision Medicine InitiativeEthical challenges

By Megan Allyse, PhD, and Richard R. Sharp, PhD

Meet Marc Myer, MD, director of the Health Care Professionals Program at Hazelden in Minnesota. As a board certified addiction specialist, Dr. Myer specializes in helping physicians, nurses, and other health care providers find freedom from addiction. He is a Diplomate of the American Board of Addiction Medicine and serves on the executive committee for Physicians Serving Physicians in Minnesota.

How prevalent is addiction in the health care profession?While the lifetime prevalence of addiction among health care professionals is similar to that of the general population—estimated at between 8-13 percent—there are some distinctions. Surgeons, especially female surgeons, have significantly higher rates of alcohol use disorders than the general population. The other dissimilarity relates to types of substances misused. Physicians are five times more likely to abuse opioid pain medications and benzodiazepine anti-anxiety drugs than the general population, which is attributable, at least in part, to greater access to and familiarity with those substances.

What barriers do health care professionals face in seeking help for addiction? Addiction is an illness driven by guilt and shame—even more so for health care professionals. The physicians and nurses I work with in treatment are wracked with guilt about having this disease. There are behavioral aspects of addiction that cause extreme

shame, which leads to deeper isolation. Fear is another powerful barrier. Fear about the consequences of admitting to addiction. Fear about loss of career, loss of license, and loss of respect among colleagues and patients. Health care professionals often feel like they have too much at stake to get help. The truth is, there’s too much at stake to not get help.

In terms of personality profile, it’s not unusual for health care professionals to have taken on a caretaker role from a young age. That means many physicians and nurses are predisposed to caring for others, often at the expense of caring for themselves. It’s part of what draws many health care professionals into the field.

Are there unique treatment challenges or issues for health care professionals?Definitely. When you’ve spent your entire career taking care of patients, it’s difficult to adopt the patient role—to be vulnerable and willing to receive help. Health care professionals tend to enter treatment at a later stage of the disease because their denial structure is so fortified; the walls have been built up through the sacrifice and determination it takes to achieve a career in medicine. Being in a treatment environment with a cohort of health care professionals—colleagues who understand the workplace dynamics, pressures, and obligations—allows for those walls to start coming down.

Does stigma play a role in facing addiction, compared with other chronic conditions, such as heart disease or diabetes?Very much so. Stigma weighs heavily even though addiction has been recognized as a disease by the American Medical

Association for decades. Like other chronic diseases, addiction can be treated and managed successfully. And for health care professionals, recovery outcomes are extremely impressive. Physicians who complete a treatment program and engage in ongoing monitoring and return-to-practice planning have recovery rates as high as 90 percent at three to five years post-treatment.

What advice do you have for health care professionals who think they might have a problem? You don’t need to self-diagnose. You can find help and answers, confidentially, from professionals who will assist with assessment, evaluation, and referral services. A starting place for many is the Minnesota Health Professionals Services Program, a state agency that coordinates diagnosis, treatment and monitoring services for health care practitioners.

Addiction is an isolating disease, especially for health care professionals. But it’s safe to reach out for help. And it’s effective. The vast majority of health care professionals who complete treatment at the Hazelden Betty Ford Foundation are able to successfully restore their careers.

Q&A WITH MARC MYER, MD

Addiction is a disease—and health care professionals aren’t immuneBut recovery outcomes are excellent for those who seek help

Marc Myer, MD, is director of the Health Care Professionals Program at Hazelden in Center City, Minnesota.

The Hazelden Betty Ford Foundation is a force of healing and hope for individuals, families and communities affected by addiction to alcohol and other drugs. It is the nation’s largest nonprofit treatment provider, with a legacy that began in 1949 and includes the 1982 founding of the Betty Ford Center. With 16 sites in California, Minnesota, Oregon, Illinois, New York, Florida, Massachusetts, Colorado and Texas, the Foundation offers prevention and recovery solutions nationwide and across the entire continuum of care to help youth and adults reclaim their lives from the disease of addiction. It includes the largest recovery publishing house in the country, a fully accredited graduate school of addiction studies, an addiction research center, an education arm for medical professionals and a unique children’s program, and is the nation’s leader in advocacy and policy for treatment and recovery.

5420-2 (8/15) ©2015 Hazelden Betty Ford Foundation

Call for a free, confidential consultation today, 800-257-7800. We answer the phone 24/7.Learn more at HazeldenBettyFord.org/HealthCareProfessionals.

An approach to consider for type 2 diabetes therapy

starts here

WARNING: RISK OF THYROID C-CELL TUMORSIn male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, and see Brief Summary of Prescribing Information on following pages. Please see Instructions for Use included with the pen.

Select Important Safety InformationTrulicity™ is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.

032739-3_eldhcp_DG97710_jrl_ad_mpp_fa3.indd 1 8/25/15 11:41 AM

September 2015 Minnesota Physician 3

* In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose; the percentage of patients achieving A1C <7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1-5

Trulicity may be a good option to be used along with diet and exercise for adult patients with type 2 diabetes who need more control than one or more oral medications alone are providing.1

Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg.

To learn more about Trulicity and the savings card for patients, talk to your Lilly sales professional or visit www.trulicity.com.

Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Not recommended as fi rst-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor fi ndings to humans. Prescribe only if potential benefi ts outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.

Select Important Safety Information

• Trulicity is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.

• Cases of medullary thyroid carcinoma (MTC) in patients treated with liraglutide, another GLP-1 RA, have been reported in the postmarketing period; the data in these reports are insuffi cient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

• Pancreatitis has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confi rmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

• The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia.

Trulicity offers proven glycemic control* and once-weekly dosing in the Trulicity pen


4 Minnesota Physician September 2015

Once-weekly Trulicity 1.5 mg demonstrated comparable A1C reduction* to once-daily Victoza® 1.8 mg at 26 weeks2

-1.36-1.42

8.2

8.0

7.8

7.6

7.4

7.2

7.0

6.8

6.6

6.4Week 0 Week 8 Week 12 Week 26

†85% fewerinjections6

Victoza® (1.8 mg) (n=300; Baseline A1C: 8.1%) Injections: ~182

Trulicity™ (1.5 mg)(n=299; Baseline A1C: 8.1%)Injections: ~26

LS m

ean

A1C

(%) ±

SE

Mea

n A1

C ch

ange

from

bas

elin

e (%

)

Add-on to metformin(52 weeks)

Compared to Januvia®1,8,9

Add-on to metformin and Actos®(26 weeks)

Compared to Byetta®1,10

Add-on to metformin and Amaryl®(52 weeks)

Compared to Lantus®1,4,11,12

Add-on to metformin (26 weeks)

Compared to Victoza®2

Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)





Trulicity™ (0.75 mg) (n=281; Baseline A1C: 8.2%)

Lantus (n=262; Baseline A1C: 8.1%)

Byetta (10 mcg BID) (n=276; Baseline A1C: 8.1%)

Januvia (100 mg) (n=273; Baseline A1C: 8.0%)

0.0

-0.4

-0.8

-1.2

-1.6

-1.8

-0.2

-0.6

-1.0

-1.4


Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%)

Mea

n A1

C ch

ange

from

bas

elin

e (%

)

A1C reduction from baseline

-1.42

-1.10-0.87

-1.51-1.30

-1.08

-0.76

Placebo (n=141; Baseline A1C: 8.1%)

Data represent least-squares mean ± standard error.

-0.39 -0.46-0.63

-1.36

-0.99

A1C reduction from baseline

A1C reduction from baseline to week 262

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on the following page and accompanying Brief Summary of Prescribing Information.

Please see Instructions for Use included with the pen.

Once-weekly Trulicity delivered results* in clinical trials

Consistent with product labeling, patients randomized to Victoza started at 0.6 mg/day in week 1, then were up-titrated to 1.2 mg/day in week 2 and to 1.8 mg/day in week 3.

Trulicity recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg.

Most common side effects were gastrointestinal (GI). They were nausea, diarrhea, vomiting, and dyspepsia.

† American Diabetes Association recommended target goal. Treatment should be individualized.7

Victoza® is a registered trademark of Novo Nordisk A/S.

• 26-week, randomized, open-label comparator phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day

• Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis)

• Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met

• 104-week, randomized, placebo-controlled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day

• Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward [LOCF]); primary objective met

• 52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)

• Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using LOCF); primary objective met

• 78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)

• Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint

• Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met



Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORSIn male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insuffi cient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confi rmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice.

Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.

Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.

The most common adverse reactions reported in ≥5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%), diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%).

Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefi t outweighs potential risk to fetus.

Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages.

Please see Instructions for Use included with the pen.

DG HCP ISI 20APR2015

Trulicity™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Trulicity is available by prescription only.

Actos® is a registered trademark of Takeda Pharmaceutical Company Limited.

Byetta® is a registered trademark of the AstraZeneca group of companies.

Amaryl® and Lantus® are registered trademarks of Sanofi-Aventis.

Januvia® is a registered trademark of Merck & Co., Inc.

Other product/company names mentioned herein are the trademarks of their respective owners.

References1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.2. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily

liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357.

3. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176.

4. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) [published online ahead of print June 18, 2015]. Diabetes Care. doi:10.2337/dc14-1625.

5. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057-2066.

6. Data on file, Lilly USA, LLC. TRU20140919B.7. American Diabetes Association. Standards of medical care in diabetes—2015.

Diabetes Care. 2015;38(suppl 1):S1-S93.8. Data on file, Lilly USA, LLC. TRU20150203A. 9. Data on file, Lilly USA, LLC. TRU20150203B. 10. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto

pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167.

11. Data on file, Lilly USA, LLC. TRU20140912A. 12. Data on file, Lilly USA, LLC. TRU20150313A.

DG97710 07/2015 PRINTED IN USA ©Lilly USA, LLC 2015. All rights reserved.



Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75 PRINTER VERSION 1 OF 2

TrulicityTM (dulaglutide) DG HCP BS 20APR2015 TrulicityTM (dulaglutide) DG HCP BS 20APR2015

TrulicityTM (dulaglutide)

Brief Summary: Consult the package insert for complete prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS

• In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

• Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied.

CONTRAINDICATIONS

Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.

WARNINGS AND PRECAUTIONS

Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with

insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.

ADVERSE REACTIONS

Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg



Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75 PRINTER VERSION 2 OF 2

TrulicityTM (dulaglutide) DG HCP BS 20APR2015 TrulicityTM (dulaglutide) DG HCP BS 20APR2015

and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Immunogenicity : Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicity-treated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity : Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions : In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebo-treated patients had mean increases of up to 3%.

DRUG INTERACTIONS

Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree.

USE IN SPECIFIC POPULATIONS

Pregnancy - Pregnancy Category C: There are no adequate and well-controlled studies of Trulicity in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for clinical adverse reactions from Trulicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicity-treated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2).

No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis.

OVERDOSAGE

Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms.

PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide

• Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs. • The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range. HbA1c is especially useful for evaluating long-term glycemic control.

Eli Lilly and Company, Indianapolis, IN 46285, USAUS License Number 1891

Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com

DG HCP BS 20APR2015



Features


September 2015 • Volume XXIX, No. 6

www.mppub.com

Publisher Mike Starnes | [email protected]

editor Lisa McGowan | [email protected]

AssociAte editor Richard Ericson | [email protected]

Art director Joe Pfahl | [email protected]

office AdministrAtor Amanda Marlow | [email protected]

Account executive Stacey Bush | [email protected]

DepArtmeNtS

Mold exposure concerns 22By Rebecca Gardner, MD

The patient with diabetes 24By Scott Benson, MD

Patients with heart failure 26By Spencer H. Kubo, MD, FACC, FACP

Diabetes and cognitive 28 dysfunctionBy Amir Moheet, MD

profeSSIoNAl upDAte: publIc HeAltH

SpecIAl focuS: cHroNIc IllNeSS

cApSuleS 10

meDIcuS 13

INterVIeW 14

e-HeAltH 30The quiet revolution in health careBy David K. Haugen, MA

peDIAtrIcS 32Environmental risks to children’s healthBy Jean E. Johnson, PhD

telemeDIcINe 34Improving medical decision-makingBy Adam Darkins, MD, MPHM

Shelley R. Stanton, MD

The Federal Medical Center, Rochester

The Precision Medicine Initiative 1Ethical challengesBy Megan Allyse, PhD, and Richard R. Sharp, PhD

Diagnosing psychiatric disorders 1Can magnetic resonance-based tools help?By John D. Port, MD, PhD

Minnesota Physician is published once a month by Minnesota Physician Publishing, inc. our address is 2812 east 26th street, Minneapolis, Mn 55406; phone 612.728.8600; fax 612.728.8601; email [email protected]. We welcome the submission of manuscripts and letters for possible publication. all views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, inc. or this publication. the contents herein are believed accurate but are not intended to re-place medical, legal, tax, business, or other professional advice and counsel. no part of the publication may be reprinted or reproduced without written permission of the publisher. annual subscriptions (12 copies) are $48.00/ individual copies are $5.00.

Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs.Objectives: We will review numerous initiatives that support the development of new pathways to behavioral health care. We will introduce new ideas and discuss how to incorporate them into our health-care delivery system. We will examine the value they can bring and the challenges they will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring.

Panelists include: • Sarah Anderson, MSW, LICSW, CEO, Psych Recovery, Inc. • Lee Beecher, MD, President, Minnesota Physician-Patient Alliance • Timothy P. Gibbs, MD, FAPA, DFAACAP, Chief Medical Officer,

Natalis Counseling and Psychology Solutions• Martha Lantz, MSW, LICSW, MBA, Executive Dir., Touchstone Mental Health• Judge Kerry W. Meyer, Hennepin County Criminal Mental Health Court • Jane Pederson, MD, Medical Affairs Director, Stratis Health • Jeff Schiff, MD, MBA, Medical Director, MN Dept. of Human Services • L. Read Sulik, MD, Chief Integration Officer, PrairieCare Sponsors include: • MN Community Healthcare Network • MN Dept. of Human Services • Natalis Outcomes • PrairieCare • Psych Recovery, Inc. • Stratis Health

MINNESOTA HEALTH CARE ROUNDTABLE

Please mail, call in, or fax your registration by 11/5/2015.

Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub.com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable.

Name

Company

Address

City, State, ZIP

Telephone/FAX

Card # Exp. Date Check enclosed Bill me Credit card (Visa, Mastercard, American Express or Discover)

Signature

Email

Thursday, November 12, 2015 • 1:00-4:00 PMDowntown Minneapolis Hilton and Towers

FORTy-FOURTH SESSION

Behavioral Health IntegrationNew pathways to care

Capsules

Palliative care can improve outcomes for heart failure patientsResearchers at Allina Health’s Abbott Northwestern Hospi-tal have found that inpatient palliative care (PC) visits were associated with improved quality of life and symptom burden for patients with heart failure (HF).

The randomized trial was conducted to identify actions taken by palliative care provid-ers that led to positive outcomes for patients. Results of the study show that providing palliative care for patients with heart failure led to additive actions beyond standard care, including actions to address pain and con-versations about goals specific to their heart failure.

“More than five million Americans are living with HF and almost 50 percent will die within five years of the diagno-sis. HF is a disease characterized by hospitalizations and varying degrees of symptoms like short-ness of breath, swollen ankles,

and fatigue,” said Ann Jorgen-son, RN, researcher with Allina Health’s Division of Applied Research and lead author of the study. “Adding PC to usual care not only assists with minimizing symptoms, but perhaps even more importantly, starts the conversation about HF-specific goals and future care planning. Providing the opportunity for HF patients to receive PC is one way Allina Health honors their commitment of providing excep-tional care.”

Full results of the study, called “A Description of Inpatient Palliative Care Actions for Pa-tients with Acute Heart Failure,” were published in the American Journal of Hospice and Palliative Medicine in June. “Developing a systematic approach to identify-ing patients with PC needs and sustaining access to PC across the course of illness may provide opportunities for providers to more adequately address symp-toms of anxiety and depression and facilitate future care plan-ning,” said Jorgenson.

Study finds drug companies delay reporting serious patient harm to fdaDrug manufacturers delay reporting adverse events to the U.S. Food and Drug Administra-tion (FDA) quite often, according to a new study from the Uni-versity of Minnesota’s School of Public Health.

Researchers analyzed 1.6 million reports submitted through the FDA’s Adverse Event Reporting System between 2000 and 2014, 95 percent of which come from drug manufacturers. For each adverse event, they calculated the number of days between when doctors alerted the drug companies to when documents were submitted through the reporting system. Federal regulation requires that when drug manufacturers receive reports for serious and unexpected adverse events, they must report them to the FDA within 15 calendar days.

The results show that drug companies did not follow this regulation for about 10 percent of serious adverse event cases. More than 160,000 events were not disclosed to the FDA within the 15-day time frame, and more than 40,000 of those reports involved patient deaths.

“Our findings are even more concerning because they are likely an underestimate of the overall underreporting or mis-reporting of serious or adverse events,” said Pinar Karaca-Man-dic, PhD, associate professor of health policy at the University of Minnesota’s School of Pub-lic Health and coauthor of the study. “Our study analysis is limited to the events that are reported to the FDA and there could be cases in which drug manufacturers fail to report seri-ous or unexpected events at all by downward classifying serious reports as non-serious.”

In defense of the findings, a spokesperson for the Phar-maceutical Research and Manufacturers of America (PhRMA), which represents

10 MINNESOTA PHySICIAN September 2015

biopharmaceutical researchers and biotechnology companies, said, “It is important to remem-ber that prior to reporting any adverse event, including seri-ous unexpected adverse events, companies must investigate the reports that they receive from patients and health care pro-fessionals. Companies typically verify the accuracy of patient and physician reports, and often contact adverse event reporters to supplement the information that they provide to the FDA.”

The analysis was published online July 27 in the journal JAMA Internal Medicine. As part of the report, researchers proposed that the FDA create a regulation allowing patients to report side effects directly.

Hysterectomy linked to cardiovascular risk for women under age 50Researchers at Mayo Clinic have shown that hysterectomy may be a marker of early cardiovascular risk and disease, most notably for women less than 35 years of age.

Through the Rochester Epi-demiology Project, the research-ers analyzed 3,816 available records of women who had a hysterectomy with ovarian con-servation in Olmsted County be-tween 1965 and 2002. They then determined a randomly selected control group of another 3,816 women of the same age who had not undergone a hysterectomy and compared cardiovascular risk factors and diseases for the women. They discovered that the women who had a hysterectomy had slightly higher odds of hav-ing hyperlipidemia, obesity, and metabolic syndrome.

“Cardiovascular disease is the leading cause of death among women, and women see primarily gynecologists between 18 years and 64 years—a time when early screening for cardio-vascular disease would be im-portant,” said Shannon Laugh-lin-Tommaso, MD, obstetrician/gynecologist at Mayo Clinic and lead author of the study. “We wanted to do this study to find a gynecologic screening method for cardiovascular disease.”

In addition, stroke was sig-nificantly more common among women who had a hysterectomy

before the age of 35 compared to women of the same age who did not have a hysterectomy. Women ages 35 to 40 that had a hysterectomy were more likely to have hypertension. And women who had a hysterectomy at the age of 50 or older didn’t demon-strate any notable increases in risk factors and, contrastingly, were less likely to have had a stroke or congestive heart failure compared with women of the same age that did not have a hysterectomy.

Conference addresses Minnesota’s prescription painkiller problemMore than 1,000 Minnesota law enforcement officials, public health officials, health care professionals, attorneys, drug court representatives, medical students, government staff, and recovering addicts gathered in Minnesota on Aug. 25 to discuss the state’s prescription painkiller problem and develop solutions to address it.

The conference, called “Pain.Pill.Problem,” featured six pan-els on the topics of the impact of opioid addiction; prescribing and pain culture; pharmacy and distribution; law enforcement; opioid treatment; and recovery, prevention, and the role of the community. Several speakers took the floor, including Gov. Mark Dayton, Minnesota De-partment of Human Services Commissioner Lucinda Jesson, Sen. Amy Klobuchar, Rep. Tom Emmer, U.S. Attorney Andrew Luger, Hennepin County sheriff Rich Stanek, former Rep. Mary Bono, University of Minnesota President Eric Kaler, and others. Some recommended develop-ing a system to more closely monitor patients who are using painkillers as well as utilizing alternative pain management techniques such as acupuncture, massage, exercise, and nutrition more often.

“Narcotic painkillers are being over-prescribed in Minne-sota, leading to addiction, abuse, and serious consequences,” said Jesson. “In the last decade, overdose deaths have more than doubled. Painkillers now cause more deaths than heroin and

Capsules to page 12 September 2015 MINNESOTA PHySICIAN 11

minnesotaorchestra.org612.371.5656 / Orchestra Hall

Media Partner:PHOTOS: Hicks, Josh Kohankek, Paremski, Andrea Joynt.

Osmo Vänskä /// Music Director

SARAH HICKS AND CHEF VINCENT

natasha paremski

TcHAiKOvSKy’S FirST PiAnO cOncerTOFri nov 13 & Sat nov 14 8pm

if you were lucky enough to hear pianist natasha Paremski at our 2014 Sommerfest, you know why we invited her right back.

A MusicAl FeAst with sArAh hicksSat nov 7 8pm

We’ve cooked up the tastiest evening imaginable, with some of the Twin cities’ most popular chefs joining the Orchestra onstage.

cocaine combined. We need to have a conversation as a society about how we can treat pain in ways that restores function and this conference is a step in the right direction.”

“This gathering today proves we’re all in this together,” said Nick Motu, vice president of the Hazelden Betty Ford Institute for Recovery Advocacy. “We’ve made addressing the opioid crisis a bedrock of the advocacy efforts at our organization, and by com-ing together with others around solutions like we did today, we can make real progress against this epidemic.”

Children’s and Health-Partners receive grant to improve pediatric appendicitis diagnosisResearchers from Children’s Hospitals and Clinics of Minne-sota and HealthPartners Insti-tute for Education and Research

have received a $3.1 million, five-year grant from the National Institutes of Health to help emer-gency department clinicians di-agnose appendicitis in pediatric patients quickly and correctly.

The team hopes to lower the rate of CT scans performed on children, which are expensive and can put them at risk for ra-diation-related injuries. Accord-ing to a survey of 40 U.S. hos-pitals, appendicitis is the most common surgical emergency in pediatric patients, and CT scans are one of the most common ways they are diagnosed. CT scans are performed on up to half of pediatric patients with appendicitis.

The research team, led by co-principal investigators An-upam Kharbanda, MD, MSc, of Children’s, and Elyse Kharban-da, MD, MPH, of HealthPart-ners, will work with HealthPart-ners emergency departments across Minnesota and at Kaiser Permanente Northern California to implement new electronic de-cision support tools for children who may have appendicitis.

They will then examine whether CT scan use decreased without negative impacts on care. If it is successful, they will expand the tools to hospitals and health care systems across the U.S.

Kharbanda previously devel-oped a pilot version of the inter-vention that was implemented at Children’s for three years and showed successful outcomes.

“This grant allows us to build on more than a decade of work by developing and implementing an interactive, evidence-based, clinical decision support pro-gram to optimize care for pediatric patients presenting with acute abdominal pain,” said Kharbanda. “Especially at general and non-pediatric emer-gency departments, it’s essential to arm clinical teams with tools to help diagnose appendicitis in children without [the] use of CT whenever possible. Diagnosing appendicitis without a CT scan is safe, makes economic sense for families and health systems, and most importantly, it protects children’s health.”

Essentia Health allows patients to see caregiver notes Essentia Health has announced that as of July 1, it began allow-ing patients who have access to their medical records through MyHealth to also access notes made by their caregivers during clinical appointments and urgent care visits.

“Research shows that pa-tients value this type of transpar-ency and partnership with their healthcare team,” said Tom Wiig, MD, chief medical information officer at Essentia Health. “It’s in the best interest of our patients’ health to make this information easily accessible to them.”

To access the information, pa-tients or caregivers with MyHealth accounts may log in and click “Visit Notes.” This allows them to revisit what was covered at each visit and better understand their health and medical condition, according to Essentia Health. It can also improve communication and patient education.

Capsules from page 12

12 MINNESOTA PHySICIAN September 2015

After discovering I needed hearing aids, I wanted the best-trained, most competent and experienced audiologist I could find. I also wanted the widest selection of quality products and finest follow-up services. After information-seeking visits with several recommended audiologists, Dr. Paula Schwartz easily rose to the top of my list. Paula and her excellent group of audiologists, all with doctorates, have given me outstanding care over the past eight years.

www.audiologyconcepts.com

6444 Xerxes Ave South Edina, MN 55423 (952) 831-4222

14050 Nicollet Ave South, Suite 200 Burnsville, MN 55337

(952) 303-5895

Refer Your Patients to Audiologists that You can Trust!

You’ll love what you hear!

X 21% of diabetics have hearing loss – compared to 9% of non-diabetics

X Hearing loss is tied to three-fold higher incidence of injury-causing falls, as well as more frequent and longer hospitalizations

X Untreated hearing loss can affect cognitive brain function – and is associated with the early onset of dementia

DID YOU KNOW?


Jeffrey Miller, MD, deputy director of the Masonic cancer center at the University of Minnesota, has received an outstanding investi-gator award from the national cancer institute. only 50 researchers in the U.s. received the award this year, and Miller was the only one from Minnesota. through the award, Miller and other recipients receive seven years of financial support at up to $600,000 per year for long-term projects in cancer research. Miller’s work will focus on targeting natural killer (nK) cells to combat solid tumor malignancies through immunotherapy, which could transform how cancer is treated by eliminating side effects from chemotherapy and radiation. Miller earned his medical degree at northwestern University Medical school. he completed his resi-dency at the University of iowa and a fellowship at the University of Minnesota.

Ryan P. Williams, MD, pediatric neurologist, has joined the Minneapolis clinic of neurology’s coon Rapids and Maple Grove offices. he also provides pediatric neurology consultations at children’s hospital Minneapolis. Williams com-pleted his medical education at stanford Univer-sity and earned a master’s degree in mind, brain and education at harvard University. he trained in pediatrics at saint Louis children’s hospital and in pediatric neurology at children’s hospital

of Philadelphia. Williams has special interests in neonatal neu-rology and epilepsy.

Dylan Folkestad, MD, and Kevin Walters, MD, have joined tri-county health care as family practice physicians. Folkestad attended the Uni-versity of Minnesota, Duluth and Minneapolis schools of Medicine and completed his family

medicine residency at the Uni-versity of Minnesota Family Medicine–st. John’s hospital. he has special interests in emergency and sports medi-cine. Walters earned his medical degree at the University of north Dakota and completed his family medicine residency at oregon health sci-ences University. he has a special interest in dia-betes, heart disease, and trauma.

Robert Mutter, MD, radiation oncologist at Mayo clinic, has received a Junior Faculty career Research training award from the american society for Radiation oncology (astRo). Mutter will receive $100,000 annually for two years to study comprehensively characterized chemore-sistant triple negative breast cancer xenograft models established from patients with high-risk breast cancer in a preoperative chemotherapy clinical trial. he will investigate if chemoresis-tance predicts radioresistance and test new Dna repair strategies aimed at overcoming resistance. Mutter earned his medical degree at Vanderbilt University school of Medicine, completed a residency in radiation oncology at Memorial sloan Kettering cancer center, and completed an internship in internal medicine at University of tennessee, Baptist hospital.

Medicus

Jeffrey Miller, MD

Ryan P. Williams, MD

Robert Mutter, MD

Dylan Folkestad, MD

Kevin Walters, MD

Cancer is life changing and some cancers are harder to fight with traditional treatments. CyberKnife Center at HealthEast St. Joseph’s Hospital in St. Paul offers exclusive treatment in the Twin Cities metro area. CyberKnife targets tumors with superior accuracy, has fewer treatments, and minimal side effects. Many patients return to their usual activities right after treatment.

CyberKnife treats cancers such as prostate, lung, liver, brain and other tumors and metastases.

To learn more or to find out if CyberKnife is an option for you:

651-232-3111 | healtheast.org/cyberknife

REAL HOPE with

Treatment

6514-122457 CyberKnife Star Tribune ad.indd 1 3/10/14 11:06 AM





REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment


To learn more or refer a patient to CyberKnife:


Cancer is life changing and some cancers are harder to fight with traditional treatments. HealthEast CyberKnife at St. Joseph’s Hospital in St. Paul is proud to have over 10 years of experience and has performed more than 6,000 treatments. CyberKnife targets tumors with superior accuracy, has fewer treatments, and minimal side effects. Many patients return to their usual activities right after treatment.






REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment






REAL HOPE with

Treatment


To learn more or refer a patient to CyberKnife:


Cancer is life changing and some cancers are harder to fight with traditional treatments. HealthEast CyberKnife at St. Joseph’s Hospital in St. Paul is proud to have over 10 years of experience and has performed more than 6,000 treatments. CyberKnife targets tumors with superior accuracy, has fewer treatments, and minimal side effects. Many patients return to their usual activities right after treatment.


A healing presence

Shelley R. Stanton, MD

The Federal Medical Center, Rochester

Dr. Stanton has devoted most of her career to the care and treatment of incarcerated in-dividuals with severe and per-sistent mental illnesses. She has provided direct clinical care to inmates throughout the Bureau of Prisons, and has worked to address the critical psychi-atric, legal, and social issues associated with correctional medicine. Dr. Stanton has also worked in community mental health, as well as private prac-tice in a large group medical practice at Marshfield Clinic in Wisconsin. She is dedicated to teaching and supervising medical students and psychi-atry residents with the hope of passing on her passion for the care of those suffering from mental illness. She has spent the last nine years working at FMC Rochester, first as the clinical director overseeing the medical care at the institution, and for the last six and a half years as the chief psychiatrist.

Please tell us about the Federal Medical Center, Rochester.

The Federal Medical Center, Rochester (FMC Roch-ester) is one of six medical centers in the Federal Bureau of Prisons (BOP), and has a medical and a mental health mission. We are accredited by the Joint Commission and held to the same stan-dards as any community health care institution. FMC Rochester currently houses about 784 male inmates. About half of those inmates are here for medical or psychiatric care, while the other half are healthy individuals, most of whom are from the Midwest. We have multiple medical missions, including infectious disease, wound care, rehabil-itation/physical therapy, and long-term care. Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses. We currently have 135 patients in our mental health units.

How do mental health services at an FMC differ from those offered at other correctional facilities?

As a Care Level 4 institution, which offers the highest level of care, we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP. We have nurses on the units 24 hours a day, seven days a week. Each patient is assigned to a multidisciplinary team of profession-als including a social worker, psychiatrist, psychol-ogist, and recreation therapist. The patients meet individually with their team members regularly and with the entire team at least every 90 days. Due to the nature of their illnesses nearly all the patients are on psychiatric medications.

Patients are offered a variety of therapeutic pro-gramming, including: art and music therapy; pet therapy; group therapy; employment in our shel-tered workshop or some other work or vocational training; educational classes; drug and alcohol treatment; parenting classes, etc. Our patients reside in a therapeutic community, of which we, as treatment providers, are an integral part, as are the correctional staff.

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental disease or defect. These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment. Our goal for these patients is to improve their functioning to the point where they may eventually be placed back in their communities with the support services they need to stay stable and to keep the community safe. Typically these patients spend years with us. Some patients will never be well enough to leave, and will spend their lives with us.

Please talk about the day-to-day care you provide.

As chief psychiatrist, I have administrative duties and I oversee the care of all the psychiatric pa-tients. I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses. We have very dedicated nursing, social work, voca-tional, recreation, correctional, and psychology staff. My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit. I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers. Many of these patients suffer from neurocognitive difficulties.

In addition, I, along with a mid-level provider, act as the primary medical providers for patients on our mental health units. We have tried other models of medical care, but found this to be the most effective way of providing the kind of inte-grated care these patients need. The patients are more comfortable with a provider who knows their psychiatric condition and more important, knows them. We are sensitive to potential medication interactions, medication side effects, as well as potential medical complications associated with some psychiatric symptoms, such as psychogenic polydipsia. Of course, I consult with my medical colleagues at FMC Rochester and with my col-leagues at Mayo Clinic.

Is there enough care for the patients?

Yes. Our challenge comes when patients are releas-ing to the community. Many of the patients come from socioeconomically deprived backgrounds, and they may be returning to an area where there are only minimal mental health services available. Many are homeless and have no family support, no financial resources, and nearly all are too function-ally impaired to work full time. Our social workers devote their days to finding community resources for our patients, but it can be a very frustrating and heartrending job.

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice?

First and foremost, we are able to get to know our patients over months to years. This makes an enor-mous difference in our ability to accurately diag-nose and treat these severe, disabling conditions. Second, all medications are administered through directly observed therapy, and we know each day which patients did or did not take their medica-tions. This allows us to intervene immediately and address the adherence issues as they arise.

IntervIew

14 MINNESOTA PhYSICIAN SepTeMbeR 2015

What kind of personal safety issues must be considered when working in a prison?

Surprisingly, working in a prison is much safer for a psychiatrist than working in a community hospital or emergency depart-ment. Although some of our patients have committed acts of violence, these nearly always were when the patients were symp-tomatic. Because we know our patients so well, we know when they are decompensat-ing. We emphasize safety and security above all else, and all of us work to-gether to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons. This greatly reduces the risk of serious violence in our setting compared to the community. In my 21 years of working in prisons, I have only been as-saulted one time, and that was by a female patient at our medical center in Texas. In my four years of training at the Mayo Clinic, I was assaulted more times than that!

Finally, if a patient is losing control, we have various ways to call for help, and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance.

Correctional facilities have been referred to as “the nation’s safety net for mental health care.” What can you tell us about this?

We are still criminalizing mental illness and incarcerating people who should be in hospi-tals or other treatment settings. The promise for community resources that was made when state hospitals closed was never kept, and as far as I can tell, likely never will be kept without a major shift in public and po-

litical will. Over 300,000 individuals with se-rious mental illnesses are incarcerated in this country, and most of them are not getting the treatment they need in or out of prison. That is unconscionable to me. On any given day over 5,000 individuals with mental illness are housed in the Los Angeles County Jail. New York City releases over 25,000 individuals with mental illnesses from its jails each year, and most of these folks are released with

absolutely no resources. Jails and prisons are designed and staffed to house individ-uals charged or convicted of crimes, not to diagnose and treat severe mental illnesses. Mental illness is not a choice. It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities.

Respecting privacy concerns, can you share some success stories?

Unfortunately, I cannot provide any specific case histories, but I can tell you family members often say they have never seen their family member doing so well. They often express a great sense of relief that the person is finally getting the care they need. Our patients also frequently tell us we

have provided the best care they have ever received, medically and psychiatrically. For me, the most rewarding moment is when a patient is releasing to the community and comes by to say “goodbye.” Invariably, he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the pa-tients. I know then my goal to be a healing presence for the patients has been met.

Over 300,000 individuals with serious mental illnesses are incarcerated in this country.

SepTeMbeR 2015 MINNESOTA PhYSICIAN 15

Trust your issues to a savvy team of legal experts 763-225-6000 • www.gislason.com

Providing counsel and guidance in all Medical Malpractice issues, including:• Surgical Issues • Anesthesia Issues • Medication Issues • Nursing Issues

• Appearances before professional licensing boards

Medical Malpractice defense

Barry [email protected]

angela [email protected]

Matt [email protected]

Jennifer [email protected]

ryan [email protected]

human health. The PMI will ask participants to share not only genetic information with researchers, but a wide variety of lifestyle and medical infor-mation as well. This will allow for unprecedented research into associations between disease phenotypes, biological proper-ties, environmental conditions, and behavior. Drawing on recent advances in information technologies, these studies hope to significantly advance our understanding of human health and lead to new, individually tailored medical interventions.

It is an ambitious plan. There are also a number of practical challenges that will need to be addressed in cre-ating such a large and diverse cohort study. Here, we consider several of these challenges, with an emphasis on some of the ethical and social issues raised by the PMI.

Data sharing and privacy“We’re going to make sure

that protecting patient privacy is built into our efforts from day one.” –President Obama

There are many large biobanks in the U.S. that contain both biological samples and health-re-lated data. For example, Mayo Clinic has recruited more than 50,000 patients into its biobank, which contains blood samples and health-related data that can be used by researchers. The PMI will try to connect these collections, providing the statistical power neces-sary to identify genetic influences on complex diseases such as diabetes and heart disease. Many health systems have constructed their own databanks, often with the capacity to link biological ma-terials with electronic medical records (EMR) systems. How-ever, exporting private health

information to a centralized national database introduces a number of potential privacy concerns; these databases are not designed to be interopera-tional. Some of these concerns include:

Patient identification: Several proof-of-concept studies have shown that it is very difficult, if not impossible, to anonymize patient data stored in large research data-bases. These databases typically include ancillary data about sample donors, such as race and ethnicity, age, time and place of biobank recruitment, and current ZIP code. As a result, inferences regarding the participant’s identity may be possible. This introduces a difficult ethical tension, since the linkage of greater amounts of information to the DNA sample will increase the overall value of the collection, but will also increase the potential for individual participants to be identified based on that information.

Cyber-security: The security of large information databases has become an increasingly important public concern, as compromises to financial databases have highlighted the potential for major privacy breaches. Participants in the PMI will expect robust privacy protections to ensure that their private health information is protected against inappropriate access, manipulation, or use. Given the size of the cohort study proposed under the PMI, and the sensitivity of the infor-mation it may include, this will be a major challenge.

Mobile health engagement “[I]mportant clinical

data from electronic health records, such as laboratory test results and MRI scans, and lifestyle data, such as calorie consumption and environmental

exposures tracked through mobile health devices, will help researchers understand how genomic variations and other health factors affect the development of disease.” –The White House

The inclusion of lifestyle and environmental data re-corded via mobile devices has only recently been operation-alized in genetic research with the introduction of Apple’s iResearch platform and other applications. These platforms allow third-party researchers to develop interactive apps through which individuals can transmit personal data to researchers. There are many advantages to using these so-called mobile health (mHealth) strategies. For example, these tools do not require direct, in-person interactions between researcher volunteers and scientists and are relatively low-burden for research partic-ipants, many of whom already use mobile devices routinely. In addition, mHealth devic-es can collect large amounts of passive data, such as GPS coordinates, which can be shared with scientists without intervention from the user. In much the same way that users may allow anonymous data on web usage or Google map data to be transmitted for service improvement, participants in the PMI may transmit similar data to a research databank.

16 MINNESOTA PHySICIAN SePTeMber 2015

The Precision Medicine Initiative from cover

It is very difficult … to anonymize

patient data stored in large research

databases.

cushwakenm.com

WOODLAKE CENTRE6601 & 6625 Lyndale Ave. S., Richfield, MNUp to 20,000 Sq. Ft. available in the heart of the Twin Cities.

BILL ROTHSTEINExecutive [email protected]

DAN WICKERSenior Director [email protected]

NEWLY RENOVATED MEDICAL OFFICE SPACE FOR LEASE

SePTeMber 2015 MINNESOTA PHySICIAN 17

By making it easier to partic-ipate in biomedical research, mHealth strategies have the potential to engage a wider array of research volunteers, including socioeconomically disadvantaged populations.

On the other hand, direct interaction between research-ers and volunteers allows researchers to verify important inclusion criteria, such as age or BMI. Remote enrollment through mHealth applications requires self-reporting of these criteria. In addition, while passively collected service improvement data can be completely stripped of identi-fiers, including IP addresses, research uses of mHealth data has to be identifiable in some way in order to provide a way to link back to an individual health/research record. While some information, such as an individual’s average heart rate over time, might be considered benign, other types of data may be more sensitive. For example, GPS coordinates capturing an individual’s location at any given time may be regarded as sensitive by some people.

The passage of the Genetic Information Nondiscrimination Act of 2008 was prompted by concerns about the use of genet-ic information in employment and health insurance decisions. Storing the intimate personal details of an individual’s daily activities in a centralized data-base, while undoubtedly useful for research, will raise similar concerns about the security of this data and its potential to be used for unintended purposes.

These considerations highlight the importance of sustained public engagement and transparency with regard to data sharing policies and security measures.

Consent and autonomy“Through the consent process,

participants will control how the information is used in research and shared.” –The White House

Consent has been a vexed issue in the formation and maintenance of biobanks. There are historic difficulties with the consent individuals give researchers to store their biological materials and con-duct research over time. For example, consent standards may change, leaving valuable samples and datasets unusable because new types of research could not have been envisioned at the time samples were donat-ed. Similarly, to the extent that it may not be possible to antic-ipate the types of research that may be done in the future, some have suggested that informed consent may be impossible to achieve in this setting.

Many biobanks place few, if any, restrictions on future use of biomaterials. This is prob-lematic to many observers, who argue that this approach fails to respect the autonomy of par-ticipants, who should be given the right to determine how their biological materials are used by researchers. In addition, a nonrestrictive approach cre-ates a false dichotomy between agreeing to all future types of research, including some that may be at odds with an indi-vidual participant’s personal

values, and not participating in research at all. The PMI hopes to overcome these challenges by allowing participants to have greater control over how their samples are used and shared. This will, theoretically, be ac-

complished by maintain-ing ongoing engagement with participants, who can elect to participate in some types of research or place restrictions on their samples based on their own evolving concepts of privacy and views regard-ing the value of particular research initiatives.

This approach may prove difficult to imple-ment, however, if each of the million participants in the PMI specifies a differ-

ent set of conditions governing the use of their samples. One solution being considered is to create so-called “tiers” of permissions, in which partici-pants choose between a finite number of research applica-tions. Although this approach

is promising, it is not yet clear how these levels of participation will be defined and what addi-tional permissions participants in the PMI may desire.

Finally, there is the issue of withdrawing from the PMI. A foundational right of research participants is the right to withdraw from a study at any time, for any reason. Given the scope of the data the PMI will collect, it may be difficult to operationalize this option and enable a participant to with-draw their data. Personal data will be shared via a national data network, available to very large numbers of researchers. Once individual datasets are re-leased for analysis, it is unclear whether it would be possible to remove any individual’s person-al data at a later time. Sus-tained national dialogue will be required to assess whether this will be acceptable to individual participants and institutional review boards.

The Precision Medicine Initiative to page 18

mHealth devices can collect large

amounts of passive data.

American Diabetes Association EXPO Healthcare Professional Breakfast

Saturday, October 11, 2014 at 7:00am Minneapolis Convention Center

Meeting Room 103 DEF

What are the Most Effective Weight Loss Interventions for Diabetes and Prediabetes

Presentation by Dr. Charles Billington, MD

Losing a few pounds can dramatically improve health and quality of life especially for people with diabetes and prediabetes. Effective weight loss can involve multiple techniques and strategies including lifestyle changes, medication and surgical options. Please join us for an informative discussion on the most effective weight loss interventions for those with diabetes and prediabetes as well as how to guide your patient through the weight loss process. Objectives:

Compare the range of approaches for weight loss Describe the body’s physiologic mechanisms to protect against weight loss

Identify ways to support a patient working to lose weight

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 3, 2014

Event is free of charge and open to all healthcare professionals to attend

Return of results“As active participants, they

also will have access to their own health data, as well as research using their data, to help inform their own health decisions.” –National Institutes of Health

Historically, biobanks almost never returned information to individual participants. In recent years, however, the im-portance of offering medically significant findings to biobank participants has been revisited, with growing support for the return of certain results. The goal of providing personally rel-evant health data to participants in the PMI is in line with this more recent thinking about the reporting of results from genom-ic studies. Many observers find this intuitive—if researchers are in possession of information that could have a direct impact on individual health, it seems reasonable to expect that they take steps to share that infor-mation with them. Nevertheless,

like operationalizing consent, returning research results can be difficult and costly, particu-larly in very large studies. The medical implications of research results may be ambiguous or re-quire the involvement of a med-ical specialist for proper inter-pretation. Given the diversity of health care systems involved in a national study such as the PMI, it may be unclear how best to ensure research volunteers have access to such specialists or have some other means of respond-ing to the medical information revealed through research.

In addition, deciding which research findings rise to the level of returnable health information is not easy. Any information returned to an in-dividual for health management purposes must be validated in a laboratory certified under the Clinical Laboratory Im-provement Amendments (CLIA) and many research labs do not meet this requirement. Even if genetic research findings could be shared with participants,

surveys consistently show that most general practitioners are not comfortable interpreting genetic findings and feel unpre-pared to assist patients with ge-nomic test results. And private insurance companies and other payers may not be supportive of covering the costs of diagnostic tests and other interventions suggested by findings from research studies. While return-ing health-related information created via medical research may satisfy our ethical impulse to compensate research volun-teers, it is not clear that return-ing this information provides more benefits than burdens.

Diversity and inclusion“The PMI cohort will include

individuals from varied ances-tral, demographic, geographic, and health backgrounds who may have different preferences and risk tolerances with respect to privacy.” –The White House

The PMI has stated a strong commitment to engaging his-torically underserved communi-ties. This is critical, since many existing biobanks consist large-ly of individuals of Caucasian descent and of comparatively high socioeconomic status. Since a majority of biobanks were established at large aca-demic medical centers this is understandable, but it calls into question the representativeness of the banks in question and the generalizability of the research they sponsor. Indeed, given the tendency of genetic conditions to cluster in certain ethnic or racial lineages, some diseases may be significantly understud-ied as a result of insufficient representation.

Existing research shows higher levels of mistrust to-ward medicine and medical research among ethnic and racial minorities—especially among Latinos and African Americans. Some communities have also called for a moratori-um on genetic research, based on high visibility scandals. It is not clear that there is, as of yet, a clear plan as to how to work more closely with these com-munities in order to gain trust and, perhaps, participation. One branch of research, called

Community-Based Participa-tory Research, aims to align the values of researchers and participating communities, but even its proponents ac-knowledge that it requires large investments of time and a deep commitment to the equitable distribution of power with re-gard to research decision-mak-ing. Considerable thought is needed on how to accomplish the PMI’s diversity goals within the known restrictions of the current socioeconomic and racial inequity in the U.S.

ConclusionThe goals of precision medicine are compelling—individually tailored treatment plans that reflect the unique biological and environmental circumstances of each patient. These goals can only be achieved through large, sustained federal and private investments in genomic medicine, such as PMI. Equally important to the success of precision medicine is a commit-ment to developing new medi-cal interventions in an ethical manner that is reflective of the plurality of views that exist regarding the conduct of bio-medical research. Maintaining our longstanding commitments to promoting patient autonomy, protecting private health infor-mation, and engaging members of the public in an open and transparent manner, will be critical if the PMI is to garner the type of public support that will be essential to its success. Although we have described several ethical dimensions of precision medicine and high-lighted some potential strate-gies for engaging these topics, we expect that these conver-sations will remain prevalent in the years ahead. Our hope is that the increasing visibility of these issues will spur new types of public engagement and research on the ethical implementation of precision medicine.

Megan Allyse, PhD, is an associate consultant in the Biomedical Ethics Program at Mayo Clinic, Rochester. richard r. Sharp, PhD, is director of the Biomedical Ethics Program at Mayo Clinic, Rochester.

The Precision Medicine Initiative from page 17


gpmlaw.com | Minneapolis | St. Cloud | Fargo, ND | Washington, DC

The Gray Plant Mooty Health Law team is unmatched when it comes to knowing your health care business. Our expertise and specialization provides you a resource for all legal issues big and small.

We know health care law like the back of our dorsum manus.

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. © 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G0933

L ife. We help people get back to it!

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

To make a referral or for more information, call us at (866) GSS-CARE or visit www.good-sam.com/minnesota.


What is needed are objective diagnostic tests that not only diagnose psychiatric disorders, but predict response to treat-ment with various medications. Magnetic resonance-based technology (MR)—including magnetic resonance imaging (MRI) for detecting structural abnormalities and magnetic resonance spectroscopy (MRS) for detecting chemical/metabol-ic abnormalities—is a powerful diagnostic tool that has been applied successfully to diagnos-ing a wide variety of neurologi-cal conditions. Could MR scan-ners be used to diagnose and/or manage the treatment of people with psychiatric conditions?

Detecting psychosis with MRA large number of studies using MR scanners to obtain imaging and spectroscopic measurements of brain chem-icals (metabolites) have been performed over the past 30

years. A few of these studies have examined the role of the radiologist in identifying imaging findings in people with first-episode psychosis. Imaging is often ordered in this situation in order to detect

causes of psychosis, specifi-cally, to rule out any structural abnormalities that may explain the psychosis. A 2002 study by Lubman and colleagues reviewed 340 MRI scans of people experiencing first-ep-isode psychosis and found that while radiologists found abnormalities in 30 percent of the scans, almost all of them were benign findings, incidental to the patient’s psychotic epi-sode. In fact, not a single scan showed a finding that could be directly related to the patient’s psychosis. More recently at the Radiological Society of North

America (RSNA) 2014 meeting, Dang and colleagues presented a meta-analysis of eight studies using imaging (MR and CT) in the setting of first-episode psychosis. This larger review of 1,019 scans again found inci-

dental findings in 18 percent of the scans, but only 0.9 percent of the scans had abnormal findings that accounted for the patient’s psychosis. As a result, it seems that conventional imaging in the clinical setting has little value for diagnosing first-episode psychosis or other psychiatric conditions.

Why isn’t MR imaging or spectroscopy effective?So why has MR imaging/spec-troscopy failed to be useful in diagnosing psychiatric disor-ders? Part of the problem lies in the fact that clinical scans are trying to rule out findings that could account for various psychiatric diseases rather than trying to rule in the psychiat-ric disease itself. Indeed, as of today, the underlying causes of psychiatric illness remain for the most part unknown. Many different models have been created over the past decades that attempt to explain the origins of psychiatric disease, drawing on molecular, genetic, structural, chemical, and other evidence from animal studies, human autopsy studies, even neurosurgical studies in the live human patient. In the past few years, the body of evidence for one psychiatric disorder—schizophrenia—has grown to the point that we understand the basic underlying brain defects that cause schizophre-nia and its associated psychosis symptoms. The story is far from complete, but it’s a good start.

Schizophrenia is the most disabling of all psychiatric dis-orders. Schizophrenic patients experience a wide range of symptoms that start in late ad-olescence and early adulthood. The most dramatic are the “positive symptoms,” character-ized by delusions and auditory

hallucinations. But probably more devastating are the “neg-ative symptoms,” characterized by the inability to recognize and express emotion; decreased capacity for pleasure; problems with fluency and production of language; and problems with attention, inferential thinking, and memory. As the symptoms appear, people with schizophre-nia often experience a down-ward social spiral, dropping out of school, losing their jobs, their homes, and their families. And unfortunately a significant num-ber of them commit suicide.

Studying brain tissueFrom these individual trag-edies, however, comes hope. The Harvard Brain Tissue Resource Center has acquired a significant collection of brains of people with schizo-phrenia. Scientists from all over the world are able to study the underlying molecular and structural defects in the brains of schizophrenic people using an ever-increasing arsenal of chemical and imaging tech-niques. As such, we know more about brain abnormalities in schizophrenia than in other psychiatric diseases. From this brain tissue, we are starting to assemble a model of what goes wrong in the brains of people with schizophrenia, and poten-tially what causes the symp-toms of the disease.

Early studies of schizophren-ic brains evaluated cell density: simply count the number of cells in a given brain region, then divide by the volume of brain where the cells are located. Over two decades ago, Benes and colleagues found decreased interneuron densities in the prefrontal and anterior cin-gulate cortices of people with schizophrenia relative to normal controls. As most interneurons produce the inhibitory neu-rotransmitter GABA, early mod-els tried to understand schizo-phrenia in terms of a GABA defect, with less GABA causing a relative increase in brain activity that might account for hallucinations. Subsequent studies from many different laboratories have focused on these GABAergic interneurons. Scientists have evaluated the

Diagnosing psychiatric disorders from cover

The underlying causes of psychiatric illness remain for the most part unknown.


WESTIN GALLERIAEDINA MN

PAIN CONFERENCESATURDAY NOV. 14th, 2015

10th ANNUAL

www.painphysicians.com888.901.7246 (PAIN) / 608-604-4659

For conference registrati on and CME programinformati on contact Ginny Cairns at:

[email protected] or 608-604-4659

REGISTER NOW!

LIMITEDSEATS

AVAILABLE

CONT

INUING MEDICAL

E D U C A T I ON

GABA-A receptor binding activ-ity on pyramidal neurons; the GAD67 (the enzyme that synthe-sizes GABA) expression within interneurons; and various inter-neuron subtype markers such as NADPH diaphorase, parvalbu-min, and calbindin.

A fingerprint of defectsThe summary of all this evi-dence shows a distinctive fingerprint of defects in schizo-phrenia. Specifically, there are GABA synthesis defects in specific interneuron cell lines (the “basket” and “chandelier” interneurons) in specific layers of the prefrontal cortex, ante-rior cingulate cortex, and hip-pocampus. These GABAergic interneurons are present, but they fail to synthesize GABA for some reason. As a side note, this is a particularly hopeful sit-uation: if one could determine how to switch on GABA produc-tion in these interneurons, per-haps the positive symptoms of schizophrenia could be reduced or eliminated.

This evidence also explains why MR imaging and spectros-copy have failed to be clinically useful in the setting of schizo-phrenia. A typical GABAergic interneuron measures between 5–10 microns in diameter, approximately the size of a red blood cell. Our best clinical im-aging at 3T can sample the brain with 1 millimeter isotropic vox-els, corresponding to a cubic re-gion of brain 1,000 microns on each side. Thus our resolution for imaging interneurons (and pyramidal cells for that matter) is approximately two orders of magnitude larger than what is needed. We simply do not have enough imaging power to detect the defects (assuming that we could “see” the GABA defect within the interneuron).

The futureThere is, of course, hope. Some of the new ultra-high-field research MR systems (7 Tesla field strength and above) can achieve much higher reso-lutions, on the order of 200

micron isotropic voxels. How-ever, even this is an order of magnitude larger than what is necessary to “see” the cellu-lar defects present within the brains of people with schizo-phrenia. Further refinements and improvements to these research MR systems are needed, and this is a field of active scientific progress.

Another area of active research is the development of new molecular MR contrast agents. These agents are com-plex, requiring the synthesis of a compound that is MR-visible, readily crosses the blood-brain barrier, and attaches only to a specific cell surface marker (e.g., a GABA-A receptor) or cell line (e.g., basket or chandelier cells). A similar set of radio-labeled compounds are being developed to be used as tracers for Positron Emission Tomogra-phy (PET). In the end, cell-spe-cific PET tracers may prove to be diagnostically more useful than MR tracers for diagnosing schizophrenia due to the much

higher sensitivity of PET rela-tive to MR.

Of course, intensive re-search is also underway for psychiatric conditions other than schizophrenia. Over the next few years, cellular and molecular abnormalities will be discovered for other psychiatric illnesses, abnormalities that lead to an imbalance in brain homeostasis and ultimately psy-chiatric symptoms. Once these abnormalities are discovered, MR tools can be developed and tailored to search for them, leading to better imaging for the diagnosis and treatment of psychiatric illness.

John D. Port, MD, PhD, is a board- certified neuroradiologist at Mayo Clinic, Rochester. He holds dual aca-demic appointments as an associate professor of radiology and an assis-tant professor of psychiatry. He has focused his career toward developing new MR-based imaging tools for diagnosing and treating disease.

SePteMber 2015 MINNESOTA PHySIcIAN 21

Only 4 Performances

Richard Strauss’ Comedic Charmer

Sept. 26–Oct. 4

9BUY TODAY!

TICKETS

START AT JUST

$25mnopera.org 612-333-6669

Professional UPdate: PUblic HealtH

As a provider in the emer-gency department (ED), I am quite comfortable

caring for STEMIs (ST segment elevation myocardial infarc-tion) and sepsis; however it’s not uncommon for a patient to come to the ED with concerns about the seemingly mundane. Many physicians may encounter patients presenting concerns regarding mold exposure and related health effects, and we often may not have the neces-sary information or be confi-dent in our guidance. As such, I have prepared a somewhat case-based guidance for more common scenarios with the hopes of answering questions and alleviating concerns, so you don’t have to spend a ton of time researching. There is also a guide to illness from mold on page 23.

Scenario

A patient presents to the ED requesting mold testing because

she has been exposed to “toxic black mold.” The patient hands you a report from a local indoor air testing company that points out the count for Stachybotrys sp. is 180 cfu/m3 in her home. The patient currently feels well and has normal vital signs.

Question 1

Q: Is there human testing that can be/should be done for mold exposure?

A: Short answer: No

• The asymptomatic person does not require any testing for mold exposure.

• We do know that molds can cause health effects, however infection in asymptomatic, healthy, immunocompetent individuals does not occur.

• The Centers for Disease Con-trol and Prevention (CDC) has not established a level of mold that equates to illness or health risk, but has a web page about mold that offers good information (cdc.gov/mold/faqs.htm). Labs and consultants may have refer-ence levels, or they may ask you to interpret these levels, however there are numerous inherent issues with home testing for mold.

• The American Academy of Allergy, Asthma & Im-munology recommends against routinely ordering a battery of IgG or IgE tests for individuals with aller-gic symptoms in order to determine the cause. They agree that these are often preferred tests, however when ordered indiscrimi-nately without considering clinical history, they may lead to a false conclusion as a person may test positive for potential allergens and the culprit allergen may not be appropriately identified. (http://bit.ly/1KKmVUe). If there is concern, refer to an allergist, immunologist, or pulmonologist.

Mold thrives in environ-ments with high moisture and water damage. Both the Envi-ronmental Protection Agency (EPA) and the CDC agree that when a building has confirmed or suspected visible mold growth, resources should be used to fix underlying water and moisture issues and to clean it

up. The building owner doesn’t usually need to spend money on the identification of individual mold species. Additionally, test-ing does not prove causation of symptoms if they exist, nor do they necessarily identify all po-tential microbes that may exist.

Question 2

Q: The patient is concerned because this particular mold is “black mold” or “toxic mold” and wonders if she needs a medication for the toxic expo-sure. She can smell the mold in her home, doesn’t that mean that she is inhaling the toxins?

A: Short answer: No

Toxic mold is a misnomer. All molds are capable of pro-ducing substances known as mycotoxins. Even though molds can produce mycotoxins, they don’t produce them at all times or in all environments. General-ly, people refer to Stachybotrys sp. as black or toxic mold, however many molds are black. Mycotoxins are not specifically proven to cause illness without ingestion of obviously moldy food. The smell produced by some molds are actually small alcohols or other organic substances that are volatile and not toxic. Mycotoxins are large compounds and do not off-gas or produce a smell. When clean-ing or repairing water-damaged areas, these may become aerosolized, but otherwise do not pose significant risk to healthy adults.

Question 3

Q: The patient is pregnant and wants to know what risk this poses to her fetus/baby?

A: Generally, the biggest health risk to individuals from mold exposure is allergic or irritant concerns. However, there is

Mold exposure concerns

A guide for physicians

By Rebecca Gardner, MD

Toxic mold is a misnomer.

22 MINNESoTA PHySICIAN September 2015

September 2015 MINNESoTA PHySICIAN 23

an association with dampness (and therefore potential mold) in the home environments of infants and development of asthma during childhood

(Reponen et al. 2011; Hu et al. 2014; and Weinmayr et al. 2013).

There has been concern about a link between exposure to Stachybotrys sp. and pulmo-nary hemorrhage in infants (Et-zel 2003). A causal relationship has not been scientifically prov-en, and more research is needed to understand all the possible health effects of mold and damp environments. The Amer-ican Academy of Pediatrics

recommends a detailed home environment history including dampness, mold exposure, and other environmental hazards when evaluating an infant with

pulmonary hemorrhage. It is recommended that the environ-ment be remediated to prevent re-exposure. The best advice to give this pregnant individual is reassurance that mold in the home does not enter the blood and cross the placenta, and therefore does not pose a risk to the pregnancy. They should be advised to have any mold and water damage abated as soon

mold exposure concerns to page 42

The asymptomatic patient does not require any testing

for mold exposure.

Guide to illness from mold mold causes illness in one of three manners:

Allergic: most common

• Initial non-emergent work-up should begin with a primary care provider.• Patients may want to check with insurance companies for preferred

providers, however they should start with primary care who can often give referrals for appropriate specialists if indicated. The Minnesota Medical Association has physician finder services available at: http://www.mnmed.org/cvweb/membersearch.shtml

Asthma

• Providers should treat asthma and respiratory issues acutely as they normally would. However, in patients with recurrent symptoms, a detailed environmental and trigger history is warranted. A referral for mitigation is warranted if indicated by water damage, visible mold, or a musty smell in the environment.

• Patients can be referred to a pulmonologist or an allergist/immu-nologist and may require pulmonary function tests (PFTs) or other testing. Skin testing, such as RAST testing may indicate sensitivity to mold, however this is positive in up to 10 percent of the population and is not indicative of the cause of current symptomatology and not inclusive of all types of mold.

Allergic rhinitis

• Patient may be referred to an allergist/immunologist.• Often related to outdoor mold more than indoor mold.• Exposure history is important: When are symptoms worse? At work?

Indoors vs. outdoors? What is work environment? Duties? Do symptoms improve on weekends? Vacations?

Hypersensitivity pneumonitis (Hp) and Allergic bronchopulmonary aspergillosis (AbpA)

• Uncommon conditions that likely require a pulmonology referral and imaging for diagnosis.

Allergic fungal sinusitis (AFS)

• May require an ENT referral.

Infectious: divided based on immune status

Immunocompromised including those with:

• Hematologic malignancy or those with other malignancy currently on strong chemotherapeutic xenobiotics.

• Stem cell or solid organ transplant on immunomodulators to prevent rejection.

• Advanced AIDS.• Known or suspected immunodeficiency disorders.• Severe uncontrolled diabetes.

• Illnesses may include local tissue or organ infection to overt fungemia and sepsis.

• Pathogens include opportunistic fungi including Candida sp., Aspergillus sp., Fusarium sp., or Mucor sp.

Immunocompetent

Uncommon pathogenic fungi found in particular environments• Histoplasma • Blastomyces• Cryptococcus • Coccidioides• Paracoccidioides • Dermatophytes (Tinea pedis, etc.)

Toxigenic: usually from moldy food

These are uncommon especially in the U.S. and typically don’t result from eating a piece of moldy cheese or bread just once. For example: Claviceps purpura contamination of rye causing ergotism• Acute convulsive ergotism• Chronic gangrenous ergotism (St. Anthony’s Fire)

• Aflatoxins from Aspergillus sp. are known historically to contaminate peanuts and are associated with hepatocellular cancer.

Specializing in Professional Liability Insurance for Physicians, Hospitals and other Healthcare ProfessionalsHandling everything from full hospital systems to individual doctors and nurses, J&R Agency has decades of experience helping Medical Professionals find the right insurance for themselves and their practice.

Our mission is to make insurance buying a positive experience through impeccable customer service and reliable support in the event of a claim.4900 Highway 169 N, Suite 225 New Hope, MN 55428

763-566-3944 or toll free 866-549-2275 www.jragency.com

Special FocuS: chronic illneSS

Diabetes remains a com-plex medical condition, potentially impacting

a patient’s physical and mental well-being. One of the best ways for physicians to help patients with diabetes reduce the risk of long-term complications and maximize their quality of life is by keeping up with standards of care.

In 2015, the Professional Practice Committee of the American Diabetes Association (ADA) revised several of the ADA standards of medical care for patients with diabetes. This committee consists of physi-cians, educators, dietitians, and experts in the areas of endo-crinology, epidemiology, public health, lipid research, hyper-tension, preconception, and pregnancy care. Following is a short overview of some of these new standards.

BMI guidelines for Asian-Americans

Studies have found that people of Asian-American heritage are

at an increased risk of diabetes at lower body mass index (BMI) levels than the general popula-tion. As a result, the guideline for screening overweight Asian Americans for prediabetes and type 2 diabetes was lowered from 25 kg/m2 to 23 kg/m2. Phy-sicians should test all of their overweight patients for diabetes starting when a patient is 45, even if the patient is without symptoms. Testing should be done sooner if the patient has one or more additional risk fac-tor for diabetes, such as family history, high blood pressure, or abnormal cholesterol and

triglyceride levels. Children and adolescents who are overweight and have two or more addi-tional risk factors should also be tested.

Sedentary time

It is not news that exercise is good for us. The ADA rec-ommends, however, that patients with diabetes should limit their seden-tary time to fewer than 90 minutes at once. Encour-age your patients to take frequent breaks from sitting and walk around or engage in exercise of some kind. In addition, adults with diabetes should make it a habit to exercise at least 150 minutes every week. Exercise is import-ant for children with diabetes, too. Encourage them to per-form 60 minutes of physical activity every day.

e-cigarettes

We all agree that smoking is harmful to our patients, whether or not they have dia-betes. There are many self-help products on the market, but the ADA does not recommend the use of e-cigarettes to help peo-ple with diabetes quit smoking, as there is no evidence that they present a healthier alternative. More study is needed to deter-mine the safety and efficacy of e-cigarettes.

Immunizations

The ADA recommends that physicians follow immunization guidelines regarding PCV13 and PPSV23 vaccinations from the Centers for Disease Con-trol and Prevention (CDC) for their patients with diabetes. The CDC recommends that children under five and adults 65 years and older receive the

pneumococcal conjugate vac-cine (PCV13). Individuals over the age of six with certain risk factors should also receive this vaccine. All adults 65 years and older, as well as those from two to 64 who are at high risk of pneumonia, should also receive the pneumococcal polysaccha-ride vaccine (PPSV23).

Blood glucose targets

The ADA recommends a blood glucose target level of 80–130 mg/dL before meals. This is a change from the 70–130 mg/dL previously recommended, based on new data. Physicians should perform an A1C test twice a year or more in patients meet-ing their goals and quarterly in those who are not.

Continuous glucose monitoring

New recommendations were released regarding continuous glucose monitoring (CGM), including additional guidance on how to assess a patient’s readiness for CGM and how to provide ongoing support to patients on CGM. Several prod-ucts are on the market today to help patients with continuous glucose monitoring, including a product in development by Medtronic to enable people with diabetes under intensive insulin therapy to view their glucose levels in real time on their smart phones.

Approaches to glycemic treatment

With the revised Standards of Care, the type 2 diabetes man-agement algorithm was updated to include the latest therapies for diabetes management. The ADA recommends letting the patient guide the choice of med-ications, taking into account efficacy, cost, potential side effects, weight, comorbidities, hypoglycemia risk, and individ-ual preferences.

The patient with diabetes

Revised standards of care

By Scott Benson, MD

24 MINNESOTA PhySICIAN September 2015

Patients with diabetes are living longer.

612.338.4333 | 800.336.9924www.jsgalleries.com

4811 Excelsior Blvd., St. Louis Park, MN 55416

Modern Masters ShowFeaturing the works of

PicaSSoReMbRandtchagall MiRÓdali Saturday, October 17 5:00 to 8:00 pm

Blood pressure goals

Based on the results of clinical trials, the diastolic blood pres-sure recommended goal was changed from 80 mmhg to 90 mmhg for most people with dia-betes and hypertension. Some patients may still benefit from lower blood pressure targets, however, so physicians need to consider other factors involved in a patient’s medical condition.

Statins

The guidelines for treating patients with statins also was recently updated by the Amer-ican College of Cardiology and the American heart Association. The initiation of treatment is now based on risk status instead of LDL cholesterol level. Patients should be screened when diabe-tes is diagnosed or at the age of 40 and periodically after that.

Foot care

Because diabetes can cause complications involving the feet, physicians should exam-ine a patient’s feet, including the assessment of foot pulses, at every visit if the patient has a history of foot ulcers, foot deformities, or other foot issues. Patients with a positive ankle-brachial index should be referred to a vascular specialist for further treatment.

Kidney disease

The ADA recommends that glucose and blood pressure be controlled to reduce the risk or slow the progression of diabetic kidney disease, which occurs in up to 40 percent of patients with diabetes. It is the leading cause of end-stage renal dis-ease. Follow glucose and blood pressure targets to minimize this condition.

Targets for children

The A1C guideline for children is now <7.5 percent but physi-cians are encouraged to assess a child’s individual risks. If signs and symptoms indicate the presence of other autoim-mune diseases in children with type 1 diabetes, such as thyroid dysfunction or celiac disease, children should be assessed at diagnosis.

Pregnancy guidelines

Gestational diabetes can develop in any pregnant woman, but higher-risk indi-

viduals are those older than 25, overweight, with a fam-ily history of diabetes, or of African-American, hispanic, American Indian, or Asian descent. Women with a history of gestational diabetes should be screened throughout their lifetime for the development of diabetes or prediabetes. A new section was added to the “Standards of Medical Care in Diabetes–2015” to address issues such as preconception counseling, medications, blood glucose targets, and monitoring.

Other considerations

Treating patients with diabetes requires a broad understanding of the compli-cations and comorbidities that often accompany the disease. A multidisciplinary care team, including physicians, nurses, dietitians, pharmacists, and mental health providers, can provide the most comprehen-sive care to these patients.

Some elements of diabetes management have not changed but bear repeating. In addi-tion to serious cardiovascular issues, other common comor-bid conditions in patients with diabetes of any kind include sleep disorders, arthritis, liver disease, cancer, hip fractures, low testosterone in men, peri-odontal disease, and hearing decline. In addition, people with diabetes are more likely to develop depression, anxiety, eating disorders, and cognitive decline than those without the disease, and these conditions often lead to worse outcomes

for the patient. As a result, phy-sicians should routinely screen for mental health issues in their patients with diabetes.

As diabetes care improves, patients with diabetes are living longer and experiencing more of these comorbidities. It is more critical, therefore, to put together a comprehensive plan to help patients lower their blood pressure, control their cholesterol, stop smoking, lose weight, and exercise.

Although the Standards of Care are valuable, common sense and professional judgment

still need to prevail. The Stan-dards of Care put forth by the ADA need to be used in conjunc-tion with a physician’s expert opinion and personal knowledge of each patient. As Diabetes Care cited in its January 2015 issue, “The Standards of Care recom-mendations are not intended to preclude clinical judgment and must be applied in the context of excellent clinical care, with ad-justments for individual prefer-ences, comorbidities, and other patient factors.”

For more information on the new Standards of Care, visit American Diabetes “Standards of Medical Care in Diabetes – 2015” at http://care.diabetesjournals.org

Scott benson, mD, is a board-certi-fied family medicine physician at the Apple Valley Medical Center. He has a special interest in non-operative orthopedics, sports medicine, and chronic disease management.

September 2015 MINNESOTA PhySICIAN 25

A multidisciplinary care team, including physicians, nurses,

dietitians, pharmacists, and mental health providers, can provide the most comprehensive care to these patients.

MAKE A REFERRAL952.548.8700 l www.stdavidscenter.org

I belongHERE.

Early Childhood Education • Autism ServicesPediatric Speech, Music and Occupational Therapy

Children’s Mental Health • Special Needs Support Services



the high frequency of readmissions within 30 days of discharge

from a heart failure related hospitalization is a hot topic among primary care physicians, hospitalists, and cardiologists. in 2015, the penalty for a hospital having rates above the expected reached its maximum, with up to 3 percent of all Medicare reimbursement withheld by the centers for Medicare & Medicaid services.

clinicians are bombarded with countless journal articles and news releases that highlight specific interventions that have successfully reduced the rate of readmissions. Which intervention works best? Which one will work in your hospital? our experience working with patients with heart failure at allina’s United hospital provides some information and insight that applies to a wide range of health care facilities.

Common themes emergealthough the details of readmissions vary from hospital to hospital, two commonly accepted themes have emerged:

1. One size does not fit all. Many interventions have

reduced readmissions, including medication reconciliation by pharmacists, implantable hemodynamic monitors, and referrals to cardiac rehabilitation. there is no single “magic” bullet that will work in every instance, so the best intervention for a particular hospital will vary, depending on geography, case mix, and available resources.

2. Not all readmissions are preventable.

in fact, some readmissions indicate good medical care! this observation has been especially polarizing because the simple 30day readmission statistic clearly includes some rehospitalizations that actually indicate excellent followup care. For example, patients with heart failure typically have multiple comorbid conditions that may require a hospitalization independent of the initial reason for admission to the hospital. consider the patient who develops newonset rapid atrial fibrillation or the patient who has a stroke while on therapeutic doses of coumadin. Many experts have suggested a separation into preventable readmissions that occur within seven days of discharge and readmissions that occur after seven days, which frequently reflect a progression of the disease or other comorbid conditions and do not necessarily indicate inadequate medical follow up.

Our experience We assembled a small team that included a cardiologist, the director of the outpatient cardiology clinic, and an inpatient cardiovascular nurse specialist so that all the key patient settings were represented. clinicians are trained to act quickly and there was a tendency to settle on a solution that “should work” and start implementation right away. however, we were very methodical about gathering the data to help us develop the most effective outcome.

First, we reviewed the medical record of every patient who had a 30day readmission over a 12month period. We found that the primary reasons for readmissions were varied and reflected medical complexity. some were related to fluid

overload or hypotension, but others were due to patient noncompliance, such as polysubstance abuse. some were related to a scheduled procedure. this might include a patient who was allowed to “recover” at home prior to being readmitted for valve replacement surgery or cardioversion. still others were related to comorbid conditions, such as new onset atrial fibrillation or an incarcerated hernia. From this analysis we understood that a simple intervention, such as a scale so that patients could weigh themselves at home, would not be uniformly effective. Further, since these patients had complex and interrelated medical problems, we quickly realized that we needed a clinician to help guide the patient through a successful transition from hospital to home.

a second observation was that it was very difficult to translate the issues and contingencies that occurred in the hospital to outpatient clinicians who were not involved in the hospitalization. consider the patient with massive fluid overload and treated with an intensified diuretic regimen. at some point, when the patient becomes an outpatient, the diuretic regimen has to be decreased or the patient will develop hypotension or worsening renal insufficiency. But the exact timing of that transition is not easy to predict or communicate to the clinic staff. this problem is accentuated by our health care systems, which in an effort to maximize efficiency and effectiveness, inadvertently create silos and barriers to integration. specifically, hospitalists and inpatient nurses stay with the patient only during hospitalization. clinic nurses and primary care physicians only assume care once the patient visits the clinic. We have discharge orders in the electronic health record, but these documents can’t always reflect the nuances and changes in clinical conditions. thus, it is not surprising that the plan derived during the hospitalization cannot always be effectively executed during the handoff from hospital to home.

Patients with heart failure

Reducing hospital readmission rates

By Spencer H. Kubo, MD, FACC, FACP

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at www.minneapolisclinic.com

Exceptional Personalized Neurologic Care

Burnsville 952.435.8516

Coon Rapids 763.427.8320

Edina 952.920.7200

Golden Valley 763.588.0661

Maple Grove 763.302.4114

Outreach Clinics throughout MN & western WI


Coordination of careour solution was to introduce a heart failure care coordinator, something we modeled after a successful program at Mercy hospital in coon Rapids. We recruited nurses with cardiovascular experience in caring for patients with heart failure. We identified patients who had risk factors for rehospitalization based on an algorithm developed by allina health. the heart failure care coordinator established a relationship with the patient and closely followed him or her during hospitalization. this was important so the patient could contact a familiar person to address questions as an outpatient.

another key is that the heart failure care coordinator, while not directly involved with inpatient care, had an intimate knowledge of the issues and the possible outpatient adjustments. the care coordinators made frequent phone calls (sometimes daily!) to the patient tracking weight, symptoms, and medications, which could be overwhelming, especially for an elderly patient. they connected with staff at skilled nursing facilities. sometimes they had to prioritize and sequence followup visits, such as those to dialysis, a primary care physician, or cardiologist. Many times, they reconciled medication doses and different pill strengths. they reviewed what the patient was eating and helped to interpret different symptoms. they alerted the clinic physicians with very specific followup information so that the physician could focus in on the most relevant issues at the clinic visit. this was the ultimate in care coordination because the coordinators helped to connect all the providers (primary care physicians, nurse practitioners, cardiologists, rehab personnel, home care nurses, and transitional care units) to improve patient outcomes.

The resultsour program was launched at United hospital in June 2012 with almost immediate results. our average 30day readmission rate was reduced from a peak of 22.4 percent in 2012 to 14.2 percent for the remainder of the year. encouraged by these initial results, we expanded the program to abbott northwestern hospital in august 2013, again with almost immediate results indicating a dramatic reduction in 30day readmissions.

We are now able to report results on a systemwide level. When combining the four cardiovascular hospitals for allina health (United [UtD],

Mercy [Mcy], Unity [Uty], and abbott northwestern [anW]), we have seen a dramatic and progressive decline in the 30day readmission rate. the readmis

sion rate prior to implementation of the heart failure care coordinators was 19.7 percent, which has been reduced to 16.7 percent (p<0.001) (see Figure 1). Furthermore, the rates of followup visits that are completed within five days of discharge have increased from 39.8 percent to 58.2 percent (p<0.001) (see Figure 2).

We have now expanded our heart Failure program to include representatives from all the major cardiovascular hospitals and all the various disciplines and patient touch points, such as pharmacy, rehab, and social work. this program provides education, training, and other resources for clinical staff at our other hospitals and clinics. our experience points to the success and reward of taking a careful analytic approach to a problem and developing a focused intervention that improves the process of care by connecting and coordinating hospital, home, inpatient providers, and outpatient providers. We have clearly made an impact on 30day readmission rates and are looking to extend our focus on care coordination beyond 30 days so we can continue to improve the care delivered to our patients with heart failure.

Some readmissions indicate good medical care!

Spencer H. Kubo, mD, FACC, FACp, is a cardiologist with the United Heart and Vascular Clinic. He is board-certified in cardiovascular disease and has a special interest in patients with heart failure.

Figure 2: Five-day follow-up rates

Figure 1: HF readmission rates

population: HF patients who are eligible for readmission flag; numerator patients with readmission flag Yes, denominator patients with readmission flag Yes and No (N/A not counted); significance analyzed with Chi-Squared tests, 1 degree of freedom. pre and post Dates: ANW 01/2009-09/2013 (Pre), 10/2013-05/2015 (Post); MCY/UTY 01/2009-12/2009 (Pre), 01/2010-05/2015 (Post); UTD 01/2009-05/2012 (Pre), 06/2012-05/2015 (Post)

population: HF patients who are eligible for follow-up flag; numerator patients with follow-up Yes, denomina-tor patients with follow-up flag Yes and No (N/A not counted); significance analyzed with Chi-Squared tests, 1 degree of freedom. pre and post Dates: ANW 01/2009-09/2013 (Pre), 10/2013-05/2015 (Post); MCY/UTY 01/2009-12/2009 (Pre), 01/2010-05/2015 (Post); UTD 01/2009-05/2012 (Pre), 06/2012-05/2015 (Post)

p<0.001

p<0.001

■ Pre ■ Post

■ Pre ■ Post

30-Day Readmission Rates for Heart Failure VisitsPre- vs. Post-Care Coordination Program by Site

5-Day Follow-Up RatesPre- vs. Post-Care Coordination Program by Site

25%

20%

15%

0%ANW MCY/UTY UTD Combined Metro

19.6%18.4%

21.6%

16.2%

18.9% 19.7%

16.7%16.3%

80%

70%

60%

50%

40%

0%ANW MCY/UTY UTD Combined Metro

41.6%47.0%

52.0%

65.9%

33.5%39.8%

58.2%56.3%

Quality Transcription, Inc.

Settingthe

standardsfor

excellence

Quality Transcription (located in Minnesota)maintains a professional office environment,thus the confidentiality of your work is strictlymaintained. We provide medical transcriptionservices on a contract or overload basis.

Our equipment is state of the art with 24 hourdictation lines and nationwide accessibility.

We are experts in our field. We deliver ontime. We have experienced staff. We monitorthe quality of our work.

We provide services tailored to your needs andwill do whatever it takes to get the job done.

Quality Transcription, Inc.8960 Springbrook Drive, Suite 110Coon Rapids, MN 55433Telephone 763-785-1115Toll Free 800-785-1387Fax 763-785-1179e-mail [email protected] www.qualitytranscription.com



Diabetes is steadily becoming an epidemic in the United states.

according to the centers for Disease control and Preven-tion’s (cDc) national Diabetes statistics Report, 2014, an esti-mated 29.1 million people or 9.3 percent of the population have diabetes. and of the 29.1 million people approximately 8.1 mil-lion people were undiagnosed. By 2050, the cDc estimates that one in three people will be diagnosed with prediabetes, the precursor to type 2 diabe-tes. Unfortunately, health care providers are seeing more cases of type 2 diabetes in younger populations and also with more people living longer lives, the incidence of diabetes in seniors (65+) remains incredibly high at an estimated 25.9 percent. type 1 diabetes accounts for 5 percent of diabetes cases and is usually diagnosed in children and young adults. Diabetes was the seventh leading cause of death in the U.s. in 2010 and cost the already overwhelmed

health care system an estimated $245 billion in 2012. in addition to death, some of the major complications include ampu-tations, kidney disease, stroke, and heart attacks. While diabe-tes-related complications in the kidneys, eyes, cardiovascular system, and peripheral nervous system are well established, there is an increasing body of research identifying the effects of diabetes on the brain.

Cognitive impairmentBoth type 1 and type 2 diabe-tes have been associated with cognitive impairment and structural changes in the brain. Multiple areas of cognition are

altered by both type 1 and type 2 diabetes. in type 1 diabetes, cognitive domains of attention, slowing of information pro-cessing, psychomotor speed, mental flexibility, and general intelligence are most commonly affected, whereas in type 2 diabetes, deficits are mostly seen in memory, psychomotor speed, and executive function. cognitive impairment can be seen early in the course of type 2 diabetes and even patients with prediabetes appear to be affected. the decline in cogni-tive function associated with diabetes is usually mild to moderate in magnitude. type 1 diabetes is usually diagnosed at a young age and may have effects on brain development. type 2 diabetes is commonly associated with obesity, insulin resistance, hypertension, and dyslipidemia, all which of can have a negative impact on the brain. Poor blood glucose con-trol appears to also play a role in the development of cognitive dysfunction in type 2 diabetes. in the action to control car-diovascular Risk in Diabetes—Memory in Diabetes (accoRD-MinD) study at baseline, an inverse relationship was seen between glycated hemoglobin (hba1c) and performance on cognitive testing. early age of onset, duration of diabetes, and presence of other microvascular complications like retinopathy are also important risk factors for developing cognitive decline.

Large population-based studies have shown that people with type 2 diabetes are also at increased risk of more severe cognitive dysfunction like de-mentia. in a population-based study of more than 6,000 par-ticipants, the presence of type 2 diabetes nearly doubled the risk for dementia as compared to people without diabetes.

this increased risk applied to both alzheimer’s and vascular type dementias. the under-lying mechanisms that may lead to development of more severe cognitive dysfunction like dementia in some but not all people with diabetes are not well understood.

Researchers have used neuroimaging techniques to ex-amine the structural correlates of cognitive dysfunction in diabetes and to provide insights into the underlying mechanism of brain-related complications of diabetes. Both type 1 and type 2 diabetes are associated with reduced total and regional brain volumes as compared to non-diabetic controls. Re-duced brain volumes have been associated with poor glycemic control. Both type 1 and type 2 diabetes are also associated with increased hyperintense white matter lesions in the brain, which are believed to represent abnormalities in the cerebral microvasculature. changes in brain structure have been associated with decline in cognitive performance.

Potential mechanisms the underlying pathophysio-logical mechanisms leading to these changes in cognition and structure are not well under-stood. several mechanisms including the role of hypergly-cemia, hypoglycemia, vascular disease, oxidative stress, genetic predisposition, and insulin resistance have been proposed as potential causes. Many of these factors are interrelated and it is likely that an underly-ing mechanism of cognitive dys-function involves a combination of these factors.

Studying the impact on brain structureVarious neuroimaging tech-niques have been used to study the impact of diabetes on brain structure. along with my col-league elizabeth seaquist, MD, we are closely collaborating with the center for Magnetic Resonance Research (cMRR) at the University of Minnesota and are utilizing state-of-the-art magnetic resonance imag-ing (MRi) technology to better understand and evaluate the

Diabetes and cognitive dysfunction

A look at the underlying pathophysiology

By Amir Moheet, MD

For more information: Email: [email protected]

Telephone: 651-426-6995

• ExcellentopportunitytotransitionfromtraditionalOBpractice

• Strongpotentialforgrowth

• Servingover2,800patients

• LocatedinEdina,MN

• Fullrangeofaestheticservicesforwomen

• FullyequippedmedicalofficewithEMR

• Stateoftheartlasertechnology

• Willingtoexploreofferstofityourbusinessplan

• SellerwillingtoassistthepotentialMDbuyerintransition&aestheticlasertraining

Established Gynecology & Aesthetic

Practice for Sale

Email – [email protected] Telephone-651-426-6995

impact of diabetes on the brain. at the cMRR, we employ

several MRi-based techniques including structural MRi, diffusion tensor imaging (Dti), magnetic resonance spectrosco-py (MRs), and functional MRi (fMRi) to assess brain structure and function in people with di-abetes. the Dti technique can identify brain white matter mi-crostructural alterations which are not visible on traditional MRi. seaquist and colleagues were one of the first groups to use Dti to better define white matter microstructure in subjects with type 1 diabetes. seaquist found deficits in the white matter microstructure in the brain regions of the pos-terior corona radiata and the optic radiations, which correlat-ed performance on cognitive tests thought to be associated with white matter function. these results indicate that with Dti methods microstructural abnormalities can be identified in the white matter of brains of patients with diabetes and that these changes may be the cause of cognitive impairment seen in this group. Longitudinal studies using Dti methods are needed to detect and track brain white matter abnormalities over time in people with diabetes. this could potentially lead to the development of a biomarker for cognitive impairment in sub-jects with diabetes.

the hippocampus is a brain region that plays an important role in memory formation and is therefore of great interest to researchers. the hippocampus is also known to be sensitive to the effects of low and high blood glucose. hippocampal atrophy has been shown in people with alzheimer’s dis-ease and type 2 diabetes. Little is known about the effects of longstanding type 1 diabetes on the hippocampus. in one of our current research studies, we are using structural MRi and MRs methods to examine the effects of long-standing type 1 diabetes on hippocampal structure and function. the long-term goal of this project is to identify mark-ers that may predict the future risk of cognitive dysfunction in subjects with type 1 diabetes and to develop future strategies

to help people with long-stand-ing type 1 diabetes minimize the impact of the disease on cognitive function as they age.

Modern medicine and health care have allowed people with diabetes to live much longer and healthier lives. With the

growing epidemic of diabe-tes and increasing number of people with diabetes who now live to old age, diabetes-related cognitive impairment will likely have challenging future social and economic public health implications.

Understanding the impactthe initial evidence shown in several studies suggests that both type 1 and type 2 diabetes is associated with brain struc-tural changes and decrements in cognitive performance. More research is needed to under-stand the impact of diabe-tes-related cognitive decline in the daily lives of people with diabetes. the cognitive decline associated with diabetes is usually of mild to moderate degree and likely does not cause clinically significant problems in most people with diabetes. People at extremes of age are more likely to be at greater risk of having clinically meaning-ful deficits. cognitive impair-ment in children with type 1 diabetes has been shown to negatively affect their academic performance. elderly people with type 2 diabetes may also be at increased risk of having clinically significant problems with diabetes-related cognitive impairment. in older people with type 2 diabetes, cognitive impairment is associated with poor diabetes self-management, requiring more assistance with personal care and increased risk of hospitalization. a review of current literature does not support universal screening for cognitive impairment in all sub-jects with diabetes. it is import-ant to raise awareness about the

risk of cognitive impairment in diabetes among medical providers as well as subjects with diabetes and their fam-ilies. screening for cognitive dysfunction should be consid-ered in subjects with cognitive complaints or in older subjects

with type 2 diabetes, especially if there is evidence of deterio-ration in the ability to perform daily living activities.

ConclusionBoth type 1 and type 2 diabetes are associated with a decline in cognitive function. overall the magnitude of most of these cognitive decrements is modest. Future research is needed to understand the impact of this cognitive decline on the daily

lives of people with diabetes. in the elderly population, type 2 diabetes is also associated with increased risk of dementia. More research is needed to bet-ter understand the mechanisms responsible for the development changes in brain function and structure in diabetes. Future research is also needed to iden-tify the risk factors that predict which patients are at the great-est risk of developing cognitive dysfunction. this research will provide new information that will lead to the development of strategies to minimize the impact of diabetes on brain structure and function.

Amir moheet, mD, is an assistant professor in the Division of Endocri-nology, Diabetes and Metabolism at the University of Minnesota. He is board-certified in internal medicine and endocrinology. His research is focused on examining the effects of diabetes and its complications on brain metabolism, structure, and function.

Both type 1 and type 2 diabetes are associated with a decline

in cognitive function.


Do you have patients with trouble usingtheir telephone due to hearing loss, speechor physical disability?

If so…the TED Programprovides assistive telephoneequipment at NO COSTto those who qualify.

Please contact us,or have your patientscall directly, for moreinformation.

1-800-657-3663www.tedprogram.org

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth • Mankato • MetroMoorhead • St. CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

e-health

Minnesotans are actively implementing a vari-ety of transformative

health care reforms to meet the Triple Aim of improving the patient experience of care, improving the health of popu-lations, and reducing the per capita cost of health care. Amid more visible, better-known reforms is a behind-the-scenes, ongoing public/private ini-tiative that has been called health care’s “quiet revolution.” Though often less noticed, this reform is no less transformative than others, has had some of the most immediate payoffs, and is foundational for other key goals to improve patient care and reduce costs.

The objective of this sys-tem-wide shake-up is to replace outmoded, expensive manual forms of billing, payment, verifications, and other routine health care business with more efficient computer-to-comput-er electronic data interchange (EDI), to the benefit of pro-viders, payers, patients, and

taxpayers. Similar broad-scale transitions to EDI-based busi-ness were made nearly a gen-eration ago in banking, retail, shipping, and travel, and other sectors of the economy, and are now being replicated with im-portant benefits for health care.

Unnecessary, wasteful administrative costsThe costs of not winning this revolution and—conversely—the benefits of successfully automating routine health business and financial trans-actions are staggering. Several well-documented studies have concluded that American health

care administrative costs, including costs for coding, billing, and similar activities, are much higher than in other countries, and account for a greater share of overall health care spending. A widely-circu-lated study in the New England Journal of Medicine for exam-ple reported that “the United States spends $361 billion annu-ally on health care administra-tion,” an amount that is “more than twice our total spending on heart disease” and “three times our spending on cancer,” and that “fully half of these expenditures are unnecessary.”

These high administrative costs are due in part to the fact that the U. S. health care system is a complex, transac-tion-intensive industry, with more than 18 billion routine administrative data exchanges annually. This is more than 500 transactions every second to meet simple, routine business needs such as verifying insur-ance coverage, billing, checking on the status of bills, and mak-ing payments.

Minnesota easily contributes its share to the total. The state’s health plans reported process-ing nearly 68 million medical bills (claims) alone in 2014. In addition, the Minnesota Depart-ment of Human Services (DHS), which oversees the state’s Medical Assistance (Medicaid) program, reported processing nearly 32 million fee-for-service claims in 2013, the most recent year for which data was avail-able. These totals do not include the myriad of other routine business communications to establish patient insurance coverage status and benefit levels, or for prior authorization requests, payments, remittanc-es, and others. In addition, the already massive flow of these

transactions is likely to become a major flood due to a growing and aging population using more medical services, and a greater share of the population with health coverage as a result of the federal Affordable Care Act (ACA).

The sheer volume of or-dinary, ongoing health care administrative data exchanges to support primarily billing and payment is costly even under the best of circumstances. However, the problem is com-pounded because these data are often still communicated using outmoded, manual 20th centu-ry (and earlier) paper and tele-phone-based practices rather than 21st century capabilities, adding dramatically to overall costs without enhancing value.

Minnesota’s answerMinnesota’s solution to exces-sive health care transaction costs was to enact Minnesota Statutes, section 62J.536 in 2007, with first-in-the-nation requirements for the standard, electronic exchange of admin-istrative data. The law reduces wasteful friction and delays in common, recurring health-care business processes by accelerating the adoption and use of streamlined, automated EDI to replace what have often been manual, paper-based transactions.

The law applies to an esti-mated 60,000 health care pro-viders in the state, as well as to hundreds of health insurers and other business intermediaries, including many nationally, and is an important, integral part of broader state health care reforms. This broad scope is essential given the scale of the problem, and because the ben-efits to be realized accrue more rapidly as more actors become capable of interacting with each other electronically.

Revolutionary benefits—lower costs, less burdenThe advantages of a success-ful revolution to simplify and streamline health care admin-istration have been studied and reported by a number of organizations, nationally and at the level of specific transac-tions and individual physician

The quiet revolution in health care

The importance of electronic data interchange

By David K. Haugen, MA


We are specialists in Apple devices (including iPads and iPhones) and software. We also support Windows and Windows to Apple integration. We are certified through the Apple Consultants Network serving individ-uals and businesses inquiring about moving to Apple, or how to improve existing systems.

Services include:

612-643-0643www.perfecteden.com

Rapid service and reasonable ratesProviding service throughout the metro area and remote service connection throughout Minnesota

Computer Problems?

•On-sitetraining–inyourclinic,hospitalorathome

•GroupWorkshops

•ExpeditedComputerRepairs

•DataRecovery

•Systemupgrades

•Networkconnectivityissues

practices. The American Medical Association (AMA) for example, found a number of important bottom-line benefits of “e-billing” and “e-transac-tions” for physicians, including:

• Fewer claims rejections by payers and faster payment

• Reduced transaction costs and reduced time spent on activities like opening and filing mail, or in telephone conversations to track down and correct problems in billing and payment

• Reduced risks associated with more automated, se-cure electronic payments

• Simplified reconciliation of accounts with electronic remittances and electronic paymentThe national Council for

Affordable Quality Healthcare (CAQH), representing both payers and providers, contracts with a nationally recognized actuarial firm to annually mea-sure and report on the benefits of the quiet revolution. In its most recent report published in 2014, CAQH examined the costs of six common transactions, ranging from billings (claims), to determinations of patient insurance status, to payments from health plans to providers.

The study analyzed over four billion transactions across a population of over 112 million insured. It found that the “dra-matic shift from a paper-based culture to electronic transac-tions has increased accuracy and productivity, reducing costs and the ‘friction’ experi-enced by health care providers and health insurance plans.” Despite this shift however, the CAQH study also found signif-icant variability in the rates of adoption of e-transactions, from a high of 92 percent of claims on average to only 35 percent of prior authorizations. As a result, CAQH also noted that “the need for and potential gains from a more widespread use of electronic transactions remains significant.”

In more detailed quantita-tive findings, CAQH estimated that the manual forms of the six transactions studied cost health plans an average of roughly $2 each to process, compared with an average of 5 to 10 cents for

their electronic counterparts. It further estimated that health care providers paid an aver-age of more than $5 each for exchanging the paper, manual versions of the transactions, versus roughly $1.60 each for the automated, electronic versions. Scaled upward across billions of health care transac-

tions annually, CAQH estimated that the U.S. health care system could save as much as $8 billion per year if the six categories of common administrative transactions were consistently exchanged electronically.

Equally or more important, reduced administrative burdens and speedier payments means that “clinicians can spend more time seeing patients and less time filling out forms and calling health plans.” Patients also benefit when their routine insurance verifications, billing, and payment are automated, so they receive needed services as timely as possible, are charged correctly, and deal with mini-mal paperwork. Moreover, the accurate, efficient exchange of health-care business data including information about health care diagnoses, utiliza-tion, and costs, is foundation-al for achieving other health reform goals, including the effective use of health data to continually improve health care delivery, patient outcomes, and population health.

Minnesota’s collaborative approachMinnesota’s health care e-trans-actions law is designed to accelerate the broad transition to EDI-based health-care busi-ness transactions in order to achieve the benefits described earlier, and is administered by the Minnesota Department of Health (MDH). The state’s quiet revolution under the law is being conducted where it most matters—collectively and community-wide, and in the

individual decisions and actions of provider, payer, and vendor organizations.

Pursuant to state law, MDH consults with a large, voluntary stakeholder advisory organiza-tion, the Minnesota Adminis-trative Uniformity Committee (AUC) in implementing and administering the law. The AUC

is comprised of more than 40 health plans, provider organi-zations, associations, and state agencies. Together, the member organizations have collectively contributed thousands of hours of subject matter expert time in leading Minnesota’s quiet, but significant health care business revolution.

MDH and the AUC work actively at a number of levels

through open, public meetings to adopt 21st century e-busi-ness tools needed to meet 21st century demands. MDH is charged with enforcing the e-transactions law through a process that emphasizes vol-untary compliance, informal resolution of complaints, and technical assistance. The AUC publishes best practices, and other resources and tools, to provide clarification regarding the electronic exchange of the transactions and their use. MDH and the AUC collaborate in informing and responding to related federal health care administrative simplification efforts, and in providing out-reach and technical assistance to improve compliance with the law and effective use of EDI for routine business purposes.

Benefits in MinnesotaWhile Minnesota’s quiet revo-lution remains ongoing, it has already produced a number of

The state’s health plans reported processing nearly 68 million medical

bills (claims) alone in 2014.

the quiet revolution in health care to page 40

September 2015 MINNESoTA PHySICIAN 31

612.338.2029 | 218.727.8446

Healthcare Planning and Design

St. Joseph Medical Center - Waiting Area

Pediatrics

I n April 2015, the U.S. cele-brated its 45th Earth Day. Many of us have witnessed

the improvements in environ-mental and public health pro-tection that have occurred over the past 50 years. According to C. Arden Pope and colleagues in the New England Journal of Medicine (2006), as much as 15 percent of the increase in life expectancy at birth from 1980 to 2000 in many U.S. cities was attributable to reduced air pollution. Regulations lowering the allowable levels of lead in paint and gasoline led to an 84 percent reduction in children with elevated blood lead (great-er than 10 µg/dL) in the U.S. between 1988 and 2004 (Robert L. Jones and colleagues, Pediat-rics 2009). Given these advanc-es, the results of a recent report by the Minnesota Department of Health (MDH) estimating the frequency and cost of environmentally related child-hood conditions in Minnesota, and in other states, might be surprising.

The December 2014 report (Economic Burden of the Environment) examined the health and economic impact of environmental factors on two well-known childhood conditions in Minnesota, lead poisoning and asthma, in one year (2010) (see Table 1). A sup-plemental analysis in 2015 has examined the economic burden of prenatal mercury exposure in 2011 and 2012. The work was conducted by the MDH’s Environmental Public Health Tracking Program (MN Track-ing), in partnership with the Centers for Disease Control and

Prevention’s (CDC’s) National Environmental Public Health Tracking Network and five other states. It was designed to show how public health disease surveillance, biomonitoring, and economic data can be used together to inform environ-mental policy discussions and decisions. For the medical com-munity, it serves as a reminder that these environmental risks have not gone away, but continue to af-fect children in our communities and clinics.

Methods

The methods used in this report were based on a method developed and reported on a national scale in 2002 by Mt. Sinai Hos-pital pediatrician and epide-miologist, Philip J. Landrigan, MD, MSc, a leading advocate of children’s health, and his colleagues. The authors defined environmental factors as “toxic chemicals of human origin in air, food, water, and com-munities.” Total annual costs nationally for environmentally related childhood diseases, in 1997, were estimated to include $34.3 billion for lead poisoning based on lost lifetime earnings due to IQ deficits, and $2 billion for asthma exacerbations based on direct medical and indirect costs in a single year. He also estimated costs for childhood cancers and neurodevelopmen-tal disorders.

In 2011, Leonardo Trasande, MD, MPP, and Yinghua Liu, MD, MPA, of the NYU School of Medicine, updated the analysis and expanded it to include the burden of prenatal methylmer-cury exposure and attention deficit hyperactivity disorder

(ADHD). Since 2002, the meth-od has been used in a number of reports published throughout the United States, including one 2006 report by a consortium of non-governmental children’s environmental health organi-zations in Minnesota (Schuler et al., 2006). The World Health Organization used a similar approach in their 2006 report: “Preventing Disease Through Healthy Environments.”

The method used for each condition involves three key components: 1) the number of cases of the disease, 2) the environmentally attributable fraction (EAF), and 3) the cost per case. To calculate cost, we multiplied the occurrence of the condition (count or rate) by the population at risk to find the number of cases we expect in a

given year. Then we multiplied the number of cases by the EAF, and the cost per case. The EAF estimates the portion of the disease burden that would be avoided or prevented if the envi-ronmental exposure were elim-inated or reduced to the lowest possible level. Minnesota, in collaboration with other states in the CDC Tracking Network, adapted these methods using current Minnesota health, pop-ulation, and economic data.

The EAF and other compo-nents of this analysis are drawn from analyses in the literature and results may be under- or overestimates of the true eco-nomic burden.

The results

The burden of air pollution on asthma exacerbations and costs (2010). To determine the proportion of asthma costs that are attributed to envi-ronmental causes, we used an estimate from the literature of EAF = 30 percent (a range from 10 percent to 35 percent).

Environmental risks to children’s health

The value of prevention

By Jean E. Johnson, PhD

Environmental risks … continue to affect children

in our communities.

32 MINNESOTA PHYSICIAN September 2015

Creating Healing Environments for 35 Years

“We wouldn’t hesitate to work with Engan Associates again.” (Matt Reinertson, Heartland Orthopedic Specialists)

Contact us: (320) 235-0860 • http://engan.com

ENGAN ASSOCIATES

Shared Vision • Innovative Design

In other words, environmental factors are assumed to cause 30 percent of the asthma exacer-bations. Then, working closely with the Minnesota Asthma Program and using a CDC tool called the Chronic Disease Cost Calculator, we estimated that there were 78,900 children ages 0-17 treated for asthma (phy-sician visits, hospitalizations, emergency department visits, and prescriptions) in the state in one year at an average cost of $940 per child treated. From death records, we found that on average there were two pre-mature deaths per year due to asthma (2007–2011 combined). The cost per premature death of $700,000 was based on a published estimate of the pres-ent value of lifetime earnings. Lost parental earnings due to 141,000 missed school days was based on an average daily wage of $156. All totaled, the economic burden of childhood asthma in Minnesota in 2010, an annual cost, was estimated to be $31.6 million in 2014 dollars (range: $10.5 million to $36.9 million).

Childhood lead poisoning (2010) and lost lifetime produc-tivity. All cases of childhood lead poisoning are assumed to be of environmental origin, and so the EAF used in the environmental burden of blood lead poisoning is 100 percent. Although testing for blood lead is not universal in Minnesota, about 54,000 children born in 2004 were tested before the age of 6, representing about 76 percent of the birth cohort. Using data from the Minne-sota Blood Lead Information System, we determined that the average peak blood lead level was 2.5 micrograms of lead per deciliter of blood (µg/dL) among this cohort.

The health impacts of lead include a range of neurodevel-opmental outcomes, but for this analysis only the impact on IQ is calculated. Based on a formula where about half an IQ point is lost per 1 µg/dL of lead and an average lead level of 2.5 µg/dL, total IQ points lost due to lead poisoning per child in Minnesota was 1.2. Total lifetime earnings lost per child

due to IQ deficit was estimated to be 2.9 percent of estimated earnings (market productivity). Because there is no safe thresh-old for lead exposure, no child is excluded; every child born in 2004 is counted in this analysis. Altogether, we estimated that lost lifetime earnings were $1.9 billion (in 2014 dollars) for the 70,600 children born in 2004 in the state.

Prenatal mercury exposure (2011 and 2012) and lost life-time productivity. We examined the impact of prenatal mercury exposure, using methods simi-lar to the lead poisoning meth-ods, described by Trasande and Liu (2011). We used an EAF of 70 percent for prenatal mer-cury exposure, based on EPA’s 1997 Mercury Study Report to Congress, and studies in Minnesota that estimate that global and regional mercury emissions (combined) account for 70 percent of the mercury that enters Midwestern lakes, the source of mercury in local fish populations.

Unlike lead, which has no known safe level, the EPA has established a threshold for safe exposure to methylmercury. We used a threshold of 3.4 µg/L in women of childbearing age as the threshold for our cal-culation of children impacted. Based on national biomonitor-ing data, we determined that 8.6 percent of children born in 2011–2012 were born to wom-en with mercury levels above the threshold. This amounts to 5,900 babies affected in Minne-sota, and the average maternal mercury concentration was estimated to be 5.3 µg/L. The average IQ deficit for children

above the mercury threshold attributable to environmental sources was about a quarter of an IQ point, at a cost of $32.6 million (range: $22.1 to 43.1 million) in lost lifetime earnings.

Minnesota Family Environmental Exposure Tracking

The health and economic burden of environmental risks is not shared equally. Asthma emergency department

visits for children are much more common in some urban communities, where use of routine clinical care, medications, and preventive services is reduced. Blood lead surveillance and national mercury biomonitoring data also show significant disparities among some income, racial, and ethnic groups.

MDH is exploring these dis-parities further in a new study

environmental risks to children’s health to page 38

Table 1: The impact of environmental risks on children’s health in Minnesota

Childhood disease or outcome environmentally attributable

fraction (eAF)

Number of minnesota

children impacted

economic burden (adjusted to 2014 dollars)

Asthma exacerbations in 2010 for children 0–17

30 percent 78,900 $31.6 million Range: $10.5–$36.9 million (annual)

Blood lead poisoning for children born in 2004, tested through 2010

100 percent 70,600 $1.9 billion (lifetime)

Prenatal mercury exposure for newborns in 2012

70 percent 5,900 $32.6 million Range: $22.1–43.1 million (lifetime)

Source: Minnesota Department of Health, 2015

September 2015 MINNESOTA PHYSICIAN 33

Read usonlineWherever you are!

www.mppub.com

Telemedicine

Making a two-mile jour-ney to an inner-city clinic can be as

difficult for an elderly person as traveling 50 miles for care in a rural area. Improving access to care for people in a large inner city area was what first drew me to telemedicine in the mid-1990s. At that time, as the medi-cal director for a health care organization providing services in central London in England, meeting the pressing popula-tion health needs and managing clinical risk were major areas of my work. The closure of an older acute London hospital, and its relocation to a new site several miles away, had left an unanticipated gap in services—one that a minor treatment cen-ter and its associated primary care resources in the area could not fully cover.

A new solution

Confronted with providing a comprehensive portfolio of services within the constraints of existing, and immediately

planned, “bricks and mortar” health care assets in this area of London presented a seemingly insoluble equation. By chance, I learned about telemedicine as a possible solution. Serendip-itously, at exactly this time, I was participating in the review of a proposed telemedicine project, one intended to link a local hospital’s emergency room with a major trauma center 322 miles away across the Irish Sea. This acute care telemedicine project was not funded because its business case was unclear. But, my previous practical experience in implementing

health information systems, and in reorganizing health care services, meant that by ana-lyzing case mix and associated patterns of care in our minor treatment center, I developed a sound business case for using telemedicine. Kudos to the board of my organization—never having heard of telemed-icine they assessed my pro-posal, authorized this as a new clinical program, and approved funding. Then, as now, I had no particular fascination for “tech-nology for technology’s sake,” but instead possessed a laser-focus toward building cost-effective platforms that met specific clinical requirements to solve prob-lems in care delivery.

Medical decision-making

The success of this initial experience with virtual care delivery led to my ongoing adoption of telemed-icine as a way to re-engineer clinical care, and solve prob-lems in innovative ways for other organizations. Legacy health care systems have concentrated specialty expertise in large secondary and tertiary care centers, but the realities of population health is of people frequently presenting with health issues far distant from the site where the care they need is located. Legacy primary care services are, by definition, not constructed to deal with people arriving on the clinical care doorstep with urgent neurologic, cardiac, endocrine issues, etc. A clinical background in neurosurgery, where I frequently negoti-ated the pros and cons of transferring patients between hospitals, had given me a clear perspective on telemedicine

as a way to objectively provide decision-support that could transform health care delivery.

Competently and effective-ly delivered medical/surgical treatments are critical factors to getting good health care outcomes. For example, the best advice available in a small rural hospital may not always be the appropriate advice. In many instances, rapid real-time virtual access to a specialist consultation may eliminate avoidable morbidity/mortality. So, my take on telemedicine was/is not that it is about videoconferencing, monitoring people’s condition remotely in their homes, or reading digital images that have been acquired, stored, and forwarded for an opinion; it is that telemedicine can change the location of care and facilitate access to real time specialist input, which can result in improved medical decision-making.

Expanding access to care

Once attuned to telemedicine as a means of improving health care decision-making, I found it equally applicable across other medical specialties, and similarly useful in expanding access to care provided by other health professionals, for exam-ple, nurses, physiotherapists, psychologists, occupational therapists, physician assistants, etc. As a result, I switched from using the term “telemedicine” to “telehealth” to reflect the interdisciplinary teamwork capabilities that telehealth represents versus telemedicine, which denotes a physician-cen-tric approach. It thereby helped coordinate care across a continuum. Initially many clinicians I worked with were

Improving medical decision-making

A definition of telehealth

By Adam Darkins, MD, MPHM

Telemedicine changes the location of care

and improves medical decision-making.

Improving medical decision-making to page 3634 MInnESOTA PhySICIAn September 2015

Join our teamJoin our team as a primary care physician or hospitalist to grow in your profession and partner with those who share your passion.

From rural to urban settings, you’ll find a practice and community that is right for you, with ideal staff support and the widest range of clinical practice options, physician leadership opportunities and competitive benefits.

Make a difference. Join our award-winning team.

1-800-248-4921 (toll-free) [email protected]

physicianjobs.allinahealth.org

MB

081

5 ©

2015

ALL

INA

HE

ALT

H S

YST

EM

. TM

- A

TR

AD

EM

AR

K O

F A

LLIN

A H

EA

LTH

SY

STE

M. E

O M

/F D

ISA

BIL

ITY

/VE

T E

MP

LOY

ER

.

Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin.Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.

- ZERO ALCOHOL FOR NINE MONTHS.

Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin.Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.

- ZERO ALCOHOL FOR NINE MONTHS.


skeptical and resistant to using telehealth. This reaction was understandable because it was new, uncertain, and thought to diminish the clinician/patient relationship. When physicians learned firsthand from patients, how telehealth can reduce travel, be more convenient, and increase satisfaction, their perspective quickly changed.

Resisting the unknown

Typically, I’ve found that most patients enthusiastically embrace the idea of telehealth, especially when they can choose in-person care when-ever they feel it necessary. Over a century ago, there was the same level of resistance and objections from clinicians when it came to using the telephone (an early form of telehealth) in health care. I don’t currently know a single clinician who would seriously propose elim-inating the phone from their

practice. When thinking of clinical acceptance of telehealth I am reminded of the first psy-chiatrist I worked with on deliv-ering mental health services remotely (telemental health).

having thought through every issue with patient acceptance of telehealth he could think of, he eagerly waited for the feedback from his first patient on whether he had liked the telehealth experience. Then, and always afterwards, this psy-chiatrist broke out in a broad smile when telling the story. his patient said, “yes I like seeing you by video, I feel in control—I can switch you off if I want to.”

The effectiveness of telehealth

Is telehealth a panacea that should replace traditional in-person care delivery across the board? Absolutely not; it has

its limitations. Direct clinical examination is not possible by the telehealth physician. The exam usually needs to be done via another clinician who acts as a proxy, or by using an assistive technology such as ultrasound; although, in the future, haptic technologies may make virtual physical examina-tion possible. however, with a significant percentage of clini-cal diagnoses being made from taking a medical history, and the possible mismatch between where specialist expertise resides, and where patients are located, telehealth is an invalu-able adjunct to care, one that could create benefits if included in clinical pathways. I believe that, as with the telephone, pagers, faxes, and teleradiol-ogy, telehealth will eventually become ubiquitously used throughout health care. If so, it is not a question of whether this will happen, but how. We do not currently know whether the telephone is optimally used in health care, and clinicians are not systematically trained on how to use it. In the future we can do better with telehealth.

If it is a question of how, not whether telehealth will become widely adopted, how should thoughtful clinicians approach its use? I believe that it is vital that all clinicians, particularly physicians, seriously consider the appropriate role of tele-health within existing clinical pathways and take leadership roles in its implementation to ensure it is done effectively. In determining the effectiveness of telehealth, I believe it is not

just clinical effectiveness in technical terms that matters. This reminds me of the most important lesson I learned as a medical student—providing compassionate care.

Compassionate care

It was my great fortune to visit Cork, in southern Ireland one summer for an elective while I was a medical student. While studying there, a professor of surgery instilled in me the importance of “touching the patient” in order to provide effective and compassionate care. Such care involves phys-ical touch, when appropriate, as well as respecting patient’s preferences, and helping them, and their caregivers, weigh the associated risks and benefits to make the “right decisions.” Without physician buy-in, and leadership to guide implementa-tion of new virtual care sys-tems, I believe there is a danger of losing some, if not all of the ability to “touch patients” in the future. When successfully adopted and with issues such as cross-state licensure resolved, I believe that the word telehealth and other associated terms like telemedicine, ehealth, mhealth, connected care, etc., will become redundant as the various technologies and pro-cesses these terms now apply to become assimilated into routine care. If I am correct and these virtual care modalities become as commonplace as the tele-phone, they will be subsumed within the generic term “health care.” Right now, with emerg-ing trends in value-based care we have the opportunity to use telemedicine to bring about these improvements in ways that traditional payment sys-tems that are wedded to brick and mortar care have not been able to.

Adam Darkins mD, mpHm, is vice president for Medical Affairs and Technology Development at Medtronic, Inc. (Dr. Darkins’ views expressed in this article reflect his personal views and experience; but, not necessarily those of Medtronic, Inc.)

Telehealth will eventually become ubiquitously used

throughout health care.

Improving medical decision-making from page 34

36 MInnESOTA PhySICIAn September 2015

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 full-

range family medicine and internal

medicine pediatric (Med-Peds)

physicians. We offer a competitive

salary and paid malpractice.

For consideration, apply online at

healthpartners.com/careers and

follow the Search Physician Careers link

to view our Urgent Care opportunities.

For more information, please contact

[email protected]

or call Diane at: 952-883-5453;

toll-free: 1-800-472-4695 x3. EOE

healthpar tners .com© 2014 NAS(Media: delete copyright notice)

MN Physician4" x 5.25"4-color


MAYO CLINIC HEALTH SYSTEM is a family of clinics, hospitals, and other health care facilities serving more than 60 communities in Minnesota, Iowa, and Wisconsin. Mayo Clinic Health System links the expertise of Mayo Clinic in practice, education and research with the health-delivery systems of our local communities.

The Northwest Wisconsin Region opportunities include:

Dermatology Occupational Medicine Emergency Medicine Ophthalmology (General & Glaucoma) Family Medicine Orthopedics General Surgery Pediatrics Hospitalist Psychiatry (Adult & Child) Internal Medicine Pulmonary/Critical Care Nephrology Urgent Care Neurology Urology

Mayo Foundation is an affirmative action and equal opportunity employer and educator.

If you wish to learn more or to express interest in these positions, please contact us at 800-573-2580; email

[email protected]; or apply at http://www.mayoclinic.org/jobs/physicians-scientists

U:\MN Physician AUGUST 2015.docx















www.glacialridge.org

Family or Internal Medicine Physician

An ideal balance between your professional and personal life. Provide comprehensive care in a clinical and hospital practice. ER coverage available, but not required.

GRHS is a progressive 19 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cites.

For more informationCall Kirk Stensrud, CEO320.634.4521

Mail CV to:Kirk Stensrud, CEO10 Fourth Ave SEGlenwood, MN 56334

Email CV to:[email protected]

Please contact or fax CV to:

Joel Sagedahl, M.D.5700 Bottineau Blvd., Crystal, MN 55429

763-504-6600 Fax 763-504-6622

www.NWFPC.com

Join the top ranked clinic

in the Twin CitiesA leading national consumermagazine recently recognizedour clinic for providing the bestcare in the Twin Cities based on quality and cost. We are currently seeking new physicianassociates in the areas of:

• Family Practice

• Urgent Care

We are independent physician-owned and operated primaryclinic with three locations in theNW Minneapolis suburbs. Work-ing here you will be part of anaward winning team with partner-ship opportunities in just 2 years. We offer competitive salary andbenefits. Please call to learn howyou can contribute to our innova-tive new approaches to improvinghealth care delivery.

The perfect matchof career and lifestyle.

www.acmc.com |

FOR MORE INFORMATION:

Kari Lenz, Physician Recruitment | [email protected] | (320) 231-6366

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• Gastroenterology• General Surgery• Geriatrician• Outpatient

Internal Medicine

• Hospitalist• Infectious Disease• Internal Medicine• OB/GYN• Oncology• Orthopedic Surgery • Pediatrics

• Psychiatry• Psychology• Pulmonary/

Critical Care• Rheumatology• Sleep Medicine• Urgent Care

38 MINNESOTA PHYSICIAN September 2015

monitoring chemicals in preg-nant women and newborns. In June, the Minnesota Family En-vironmental Exposure Tracking (MN FEET) project, part of the MDH Biomonitoring program in partnership with West Side and HealthPartners clinics, began recruiting 600 pregnant women from four communi-ties in the Twin Cities (Hmong, Somali, Latina, and White) to measure disparities in prenatal

mercury, lead, and cadmium exposure. Maternal urine and cord blood are collected at birth and analyzed by the MDH Public Health Laboratory. It is hoped that in the years ahead

the project may expand to include more communities, and will provide Minnesota-specific data for tracking progress in reducing this health burden on Minnesota’s children.

Conclusion

From the Economic Burden of the Environment report, we know that the physical and social environments in which children live, learn, and play are important determinants of health and future success throughout their lives. By quantifying the economic burden of environmental pol-lution on child health, shown in this report, we hope to gain a greater appreciation for the value of prevention, and the continuing need for physicians to counsel and support their patients on ways to recognize and avoid these costly environ-mental hazards.

Jean e. Johnson, phD, is an environ-mental epidemiologist and director of the Environmental Public Health Tracking and Minnesota Biomon-itoring Program at the Minnesota Department of Health.

The health and economic burden of environmental

risks is not shared equally.

environmental risks to children’s health from page 33

Health care providers are key to helping their patients (parents, children, and pregnant women in particular) make healthy choices that avoid environmental risks. Minnesota physicians are reminded of the tools and educational resources that are available on the MDH website:

• Lead poisoning prevention: health.state.mn.us/lead• Interactive Asthma Action plan: health.state.mn.us/divs/hpcd/cdee/asthma/ActionPlan.html• tobacco prevention and Control: health.state.mn.us/tobacco • Fish Consumption Guidance: health.state.mn.us/divs/eh/fish/• mN Family environmental exposure tracking: health.state.mn.us/mnfeet

To learn more about the economic burden of the environment and see more on the data and methods referred to in this article, go to MDH’s Economic Burden of the Environment website: health.state.mn.us/tracking/projects/burden.html

Giving patients a healthy start in life

Boynton Health Service

Boynton Health Service

Welcome to Boynton Health Service

Located in the heart of the Twin Cities East Bank campus, Boynton Health Service is a vital part of the University of Minnesota community, providing ambulatory care, health education, and public health services to the University for nearly 100 years. It’s our mission to create a healthy community by working with students, staff, and faculty to achieve physical, emotional, and social well-being.

Boynton’s outstanding staff of 400 includes board certified physicians, nurse practitioners, registered nurses, CMAs/LPNs, physician assistants, dentists, dental hygienists, optometrists, physical and massage therapists, registered dietitians, pharmacists, psychiatrists, psychologists, and social workers. Our multidisciplinary health service has been continuously accredited by AAAHC since 1979, and was the first college health service to have earned this distinction.

Attending to over 100,000 patient visits each year, Boynton Health Service takes pride in meeting the health care needs of U of M students, staff, and faculty with compassion and professionalism.

Gynecologist/Clinical SupervisorBoynton Health Service is seeking a gynecologist or primary care physician with extensive experience in women’s health to serve as Assistant Director of Primary Care in charge of the Women’s Clinic. The Assistant Director will provide clinical services, ensure staff adherence to relevant regulations, assure the highest professional and ethical standards, and work with the Director of Primary Care and Chief Medical Officer to formulate long range planning and policies.

This position offers a competitive salary and a generous academic status retirement plan. Professional liability coverage is provided. Apply online at www1.umn.edu/ohr/employment, select “External Applicants” and then search for keyword: Gynecologist. Job ID#: 300363

To learn more, please contact Hosea Ojwang, Human Resources Director 612-626-1184, [email protected].

The University of Minnesota is an Equal Opportunity, Affirmative Action Educator and Employer

A Diverse and Vital Health Service

410 Church Street SE • Minneapolis, MN 55455 • 612-625-8400 • www.bhs.umn.edu


Sioux Falls VA Health Care System

Sioux Falls VA HCS, SD

(605) 333-6852 www.siouxfalls.va.gov

Applicants can apply online at www.USAJOBS.gov

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.

Cardiologist EndocrinologistENT (part-time)Emergency MedicineGeriatrician (part-time) HospitalistNeurologist

Oncologist/Hematologist Orthopedic SurgeonPrimary Care (Family Practice or Internal Medicine)PsychiatristPulmonologistUrologist (part-time)

www.lakewoodhealthsystem.com

Lakewood Health System is seeking to expand the care team for its progressive and patient-focused clinics and hospital. Located in Staples, Minnesota, Lakewood is an independent, growing healthcare system with fi ve primary care clinics, a critical access hospital and senior living facilities. Practice consists of 14 family medicine physicians and 10 advanced practice clinicians, as well as a variety of on-staff specialists. Competitive salary and benefi ts. Relocation and sign-on bonus available.

Visit www.lakewoodhealthsystem.com, or contact Brad Anderson at 218-894-8587 or [email protected].

POSITIONS AVAILABLE:INTERNAL MEDICINE– No call

EMERGENCY MEDICINEFAMILY MEDICINE– Full-scope practice avail. (ER, OB, C-Section, Hospitalist, Clinic)

SURROUNDED BY LAKESWORK-LIFE BALANCE

Erik Dovre, OB/GYN

Family Medicine

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 outpatient 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 benefi t package, paid malpractice and a commitment to providing exceptional patient-centered care.

Apply online at healthpartners.com/careers orcontact [email protected]. Call Diane at 952-883-5453; toll-free:800-472-4695 x3. EOE

healthpartners.com

© 2014 NAS(Media: delete copyright notice)

MN Physician4" x 5.25"4-color

d

Specialists in Nonsurgical Treatment of Neck and Back Pain

• 98% patient satisfaction• 71% of patients report a 50-100% reduction of headaches• 65% of patients report a 50-100% reduction in medication use• 101% increase in Lumbar Extension ROM & strength• 145% increase in Cervical Rotation ROM & strength

www.PDRclinics.com

Seeking:Occupational

Medicine Physician

We are looking for an individual to join our medical team and partner in expanding our service offerings to area employers and payor plans.

Competitive salary and benefits available. No “on-call” requirements. Voted three years in a row a “Top 100 WorkPlaces” by Star Tribune.

PDR Clinics is a spine specialty practice that is devoted to non-surgical care for neck and back pain patients. We use an active, biopsychosocial approach aimed at restoring functional goals through physical exercise and cognitive-behavioral therapies. Our outcomes support our model, and we have been recognized by several payors by winning innovation awards and recognition of our practice in meeting the triple-aim of patient satisfaction, quality outcomes, and affordability.

PDR Quality Outcomes

Interested? Contact

Candi Dolan [email protected]

or 952-908-2582


important benefits for patients, the health care system, and taxpayers, mirroring those identified in the studies dis-cussed. The state’s rate of health care claims submitted electron-ically is now over 97 percent compared with an average of 92 percent nationally. Anecdotal reports indicate increasing rates of EDI for other import-ant, high-volume transactions as well. MDH estimates that these improvements have resulted in overall cost savings across the state’s health care system of $40 to $60 million, and other related benefits that are likely to continue to accrue for years to come.

What makes Minnesota’s health care EDI transition revolutionary is not only what has been achieved to date, but where it is headed in the future. The state’s efforts not only build upon and complement federal administrative simplification

requirements under the Health Insurance Portability and Accountability Act (HIPAA) and the ACA, but extend more broadly to proactively meet new business needs and challenges.

For example, HIPAA ex-empts certain types of insurers

such as workers’ compensation, property-casualty, and auto, from administrative simplifi-cation provisions. Minnesota’s administrative simplification initiative includes those payers to assure that the benefits of EDI are achieved as broadly as possible.

Similarly, state law requires the use of EDI in areas not yet addressed by HIPAA or the

ACA. For example, prior autho-rizations for prescription drugs are frequently required as part of the prescribing process, and can be an overwhelming administrative burden when conducted manually via fax or over the phone. In response,

state law requires that prior authorizations for prescription drugs be exchanged electron-ically beginning Jan. 1, 2016. At the same time, Minnesota requires the seemingly sim-ple, yet revolutionary step of requiring the senders and receivers of business transac-tions to acknowledge that they have received them, as well as in some cases to provide

information about any prob-lems encountered along the way or next steps in the transaction processing. These and other hallmarks of Minnesota’s quiet revolution are paving the way for additional benefits and EDI improvements in the future, to continue to best meet 21st century health-care business needs while reducing health-care administrative costs.

For more information regarding Minnesota’s health care administrative simplifica-tion effort, please see the MDH website at www.health.state.mn.us/asa/ and the AUC website at www.health.state.mn.us/auc/index.html

David K. Haugen, mA, is the director of the Center for Health Care Pur-chasing Improvement at the Min-nesota Department of Health where he oversees the administration of state requirements for the standard, electronic exchange of health care administrative transactions.

Reduced administrative burdens … means that clinicians can

spend more time seeing patients.

the quiet revolution in health care from page 31

www.olmstedmedicalcenter.org

Olmsted Medical Center, a 220-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.

Opportunities available in the following specialties:

Send CV to: Olmsted Medical CenterHuman Resources/Clinician Recruitment 210 Ninth Street SE, Rochester, MN 55904

email: [email protected] • Phone: 507.529.6748 • Fax: 507.529.6622

ENTRochester Southeast Clinic

Family MedicineSpring Valley Clinic Rochester Clinics

OB/GYNHospital – New Women’s

Health Pavilion

Pain MedicineRochester Northwest Clinic

Psychiatrist – Child & Adolescence

Rochester Southeast Clinic

PsychiatristRochester Southeast Clinic

Sleep MedicineRochester Northwest Clinic

UrologyHospital


Opportunities for full-time and part-time staffare available in the following positions:

US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Education Debt Reduction Program funding may be authorized for the health professional education that was required of the position. 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

Nola Mattson, [email protected] Resources

4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

• Associate Chief of Staff, Primary Care

• Dermatologist

• Internal Medicine/ Family Practice

• Occupational Health/Compensation & Pension Physician

• Ophthalmologist

• Physician (Pain Clinic)/Outpatient Primary Care

• Psychiatrist

Applicants must be BE/BC.

St. Cloud VAHealth Care SystemBrainerd | Montevideo | Alexandria

Family Medicine & Emergency Medicine Physicians

• ImmediateOpenings• Casualweekendoreveningshiftcoverage• Setyourownhours• Competitiverates• PaidMalpractice

Great Opportunities

763-682-5906|[email protected]

www.whitesellmedstaff.com

fairview.org/physicians TTY 612-672-7300EEO/AA Employer

Sorry, no J1 opportunities.

Visit fairview.org/physicians to explore our current opportunities, then apply online, call 800‑842‑6469 or e-mail [email protected]

• Dermatology

• Emergency Medicine

• Endocrinology

• Family Medicine

• General Surgery

• Geriatric Medicine

• Hospitalist

• Hospice

• Internal Medicine

• Med/Peds

• Ob/Gyn

• Orthopedic Surgery

• Pediatrics

• Psychiatry

• Rheumatology

• Sports Medicine

• Urgent Care

• Vascular Surgery

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:

Opportunities to fit your lifeFairview Health Services

•Dermatology

•EmergencyMedicine

•FamilyMedicine

•GeneralSurgery

•GeriatricMedicine

•Hospitalist

•Hospice

•InternalMedicine

•Med/Peds

•Ob/Gyn

•OrthopedicSurgery

•PainMedicine

•Psychiatry

•Rheumatology

•UrgentCare

as possible so once the infant is born, there isn’t exposure to the newborn that may increase risk of reactive airway or other respiratory concerns.

Conclusion

In general, in people with a normal immune system, the primary health risks related to mold are allergy related. Blood testing is not recommended in individuals who are asymptom-atic who have been exposed to mold. Avoiding exposure, by moisture and water damage abatement are far more import-ant than identifying specific species or testing for mold and this is where resources should be focused.

rebecca Gardner, mD, is a board- certified emergency medicine physician with Emergency Physicians Professional Association. She is board-eligible in medical toxicology.

mold exposure concerns from page 23

• Information from the University of Minnesota for individuals who plan to mitigate indoor mold

http://enhs.umn.edu/current/5103_spring2003/indoormolds/moldcontrol.html

• Storey E., et al. (2004). Guidance for Clinicians on the Recognition and Management of Health Effects Related to Mold Exposure and Moisture Indoors. University of Connecticut Health Center

http://doem.uchc.edu/consultation_outreach/indoor_environments/pdfs/mold_guide.pdf

• World Health Organization. (2009). WHO Guidelines for indoor air quality: dampness and mould. ISBN 7989289041683. WHO regional office for Europe

http://www.who.int/indoorair/publications/7989289041683/en/

• American College of Occupational and Environmental Medicine. (2011). Adverse Health Effects Associated with Molds in the Indoor Environment

http://www.acoem.org/Login.aspx [log-in required]

• Centers for Disease Control and Prevention. (2004). Acute idiopathic pulmonary hemorrhage among infants: Recommendations from the Working Group for Investigation and Surveillance. MMWR: Morbidity and Mortality Weekly Report. 53 (RR02): 1-12

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5302a1.htm

• Robbins CA, et al. (2000). Health Effects of Mycotoxins in Indoor Air: A Critical Review. Applied Occupational and Environmental Hygiene. 15(10): 773–784

http://centerforhealthyhousing.org/portals/0/Contents/Article0277.pdf

Additional Resources


62

35W

35W

35W

35E

35E

394

94

94

494

494

69449436

36

95

212

12WAYZATA

ARDENHILLS

EDENPRAIRIE

APPLEVALLEY

NOT TO SCALE

MINNEAPOLIS

STILLWATERMAHTOMEDI

SAINTPAUL

77

51

Tickets to SPCO concerts start as low as $10! With performance venues throughout the Twin Cities, we are sure to be near you.

Visit thespco.org to view a full schedule of performances at venues throughout the metro area.

NOW ON SALE – ORDER TODAY

SPCO VENUES

Tickets start at just $10! Ticket Office:

651.291.1144Monday – Friday from 12:00 – 5:00pm Saturday from 11:00am – 3:00pm

thespco.org

is looking for primary and specialty physicians who want to help create a cure for the common coverage.

Is your health plan making you SICK?Introducing: PrimaCare Direct

++One low, monthly fee of $75.

+Unlimited primary care access

+A personal doctor, focused on your wellness

+No deductibles, copays or surprise bills

Is your health plan making you SICK?Introducing: PrimaCare Direct

+

Join Us612-444-6600

Primacaredirect.com

Physicians, are you SIcK of: Feeling like you work for insurance companies instead of patients?Declining reimbursements while your patients pay higher premiums?Hospitals dictating where you refer patients?Patients delaying or avoiding much needed care because of high deductibles?

At MMIC, we believe patients get the best care when their doctors feel calm and confi dent. So we put our energy into creating risk solutions designed to eliminate worry. 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.

Relax.Discover solutions thatput you at ease.

mn physician sept 2015

Documents