Outcomes. Endocrinology & Metabolism Institute

Outcomes 2008 Endocrinology & Metabolism Institute Institute Overview 2 To promote quality improvement, Cleveland Clinic has created a series of...
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Outcomes

2008 Endocrinology & Metabolism Institute

Institute Overview

2

To promote quality improvement, Cleveland Clinic has created a series of Outcomes books similar to this one for many of its institutes. Designed for a physician audience, the Outcomes books contain a summary of our surgical and medical trends and approaches, data on patient volume and outcomes, and a review of new technologies and innovations.

Although we are unable to report all outcomes for all treatments provided at Cleveland Clinic — omission of outcomes for a particular treatment does not mean we necessarily do not offer that treatment — our goal is to increase outcomes reporting each year. When outcomes for a specific treatment are unavailable, we often report process measures associated with improved outcomes. When process measures are unavailable, we may report volume measures; a volume/outcome relationship has been demonstrated for many treatments, particularly those involving surgical techniques.

In addition to our internal efforts to measure clinical quality, Cleveland Clinic supports transparent public reporting of healthcare quality data and participates in the following public reporting initiatives: • Joint Commission Performance Measurement Initiative (www.qualitycheck.org) • Centers for Medicare and Medicaid (CMS) Hospital Compare (www.hospitalcompare.hhs.gov)

• Leapfrog Group (www.leapfroggroup.org)

• Ohio Department of Health Service Reporting (www.odh.ohio.gov/healthStats/hlthserv/hospitaldata/hospperf.aspx)

Our commitment to providing accurate, timely information about patient care will also help patients and referring physicians make informed healthcare decisions. We hope you find these data valuable. To view all our Outcomes books, visit Cleveland Clinic’s Quality and Patient Safety website at clevelandclinic.org/quality/outcomes.

Endocrinology & Metabolism Institute

Dear Colleague, On behalf of Cleveland Clinic, I am pleased to present our 2008 Outcomes books. The primary purpose of our annual Outcomes book initiative is to promote quality improvement at Cleveland Clinic, thereby optimizing the care we provide to our patients. Measuring and reporting outcomes reflects our organizational commitment to accountability, transparency and results. Each year, external stakeholders are requiring hospitals to report more and more quality and patient safety data. We view our Outcomes books as voluntary supplements to the required public reporting and an opportunity to share selected innovations with colleagues across the country. Designed for the physician reader, each book in the annual series focuses on care provided by one of our patient-centered clinical institutes. We hope you find the content informative. Sincerely,

Delos M. Cosgrove, MD CEO and President

2

Outcomes 2008

what’s inside Chairman’s Letter

04

Institute Overview

06

Quality and Outcomes Measures

Diabetes

08



Thyroid and Parathyroid

10



Pituitary

13



Liver

15



Adrenal

16



Obesity/Metabolism

18



Surgical Quality Improvement

24



Patient Experience

28

Innovations

34

Selected Publications

40

Staff Listing

46

Contact Information

48

Institute Locations

49

Cleveland Clinic Overview

50

Resources for Physicians

51



Endocrinology & Metabolism Institute

3

Chairman’s Letter Dear Colleague, On behalf of Cleveland Clinic’s Endocrinology & Metabolism Institute, I am pleased to share our 2008 quality outcomes. Quality, transparency and outcomes measurement have always been priorities for us. The Endocrinology & Metabolism Institute formally came together on Jan. 1, 2008. It has evolved into a paradigm of what Cleveland Clinic was hoping to accomplish with its reorganization into distinct “institutes.” This particular institute comprises an eclectic group of endocrinologists, endocrine surgeons, bariatric surgeons, bariatricians, even a cardiologist, who staff three departments: Endocrinology, Diabetes and Metabolism; Endocrine Surgery; and Bariatric Surgery, which includes our Bariatric and Metabolic Institute. Full integration of these seemingly disparate units was accomplished with ease because of the spirit of Cleveland Clinic’s concept “to act as a unit.” Research projects, such as our STAMPEDE trial of bariatric surgery and best medical therapies for obesity, have profited from the multidisciplinary interaction. Academics have moved forward, with multiple joint research and education projects being developed within the institute, and patient care has clearly improved with the development of joint disease management approaches and protocols. One example emerges from our Thyroid Disease Center, where surgeons and endocrinologists manage patients in seamless fashion. Focus on pituitary and adrenal diseases has created similar results. Finally, the institute is creating a Diabetes Center with unique properties being developed in conjunction with our primary care colleagues in the Medicine Institute.

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The Endocrinology & Metabolism Institute stands ready and willing to take on all clinical challenges and offer care to patients requiring these services in truly seamless fashion. We invite our colleagues to review in detail the programs, projects and outcomes summarized in this text and to move an additional step, to truly broad-spectrum and collegial interaction with the community at large.

James B. Young, MD Professor of Medicine and Executive Dean, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University George and Linda Kaufman Chair Physician Director, Institutional Relations and Development Chairman, Endocrinology & Metabolism Institute

Endocrinology & Metabolism Institute

55

Institute Overview Cleveland Clinic’s Endocrinology & Metabolism Institute is committed to providing the highest-quality healthcare to patients with diabetes, endocrine and metabolism disorders, and obesity; to exploring ways to improve their care; and to teaching how best to treat these disorders.

6 — National ranking U.S.News & World Report gave Cleveland Clinic’s endocrinology services in 2008.

For patients with Types 1 and 2 diabetes, we provide diabetes education and nutrition services and offer an intensive insulin treatment clinic. Studies involving many new products to manage diabetes are ongoing. Our multidisciplinary diabetic care committee addresses the unique needs of inpatients throughout the hospital who have diabetes, and the ABC Club at Cleveland Clinic rewards patients with diabetes when they meet American Diabetes Association goals for A1C, blood pressure and cholesterol. Cleveland Clinic has hosted an Annual Diabetes Day for healthcare professionals for 13 years. A diabetes leadership committee has been formed to review all aspects of diabetic care and education, with a subcommittee organized to complete the business plan and vision of Cleveland Clinic’s Diabetes Center. This center has been assigned new space and will house clinical, educational and research space for our diabetic patients. We provide an array of disease-specific clinics, including pituitary, thyroid, metabolic bone and preventive cardiology clinics and a transition clinic to help children move on to adult endocrine care. For all our patients with endocrine disorders, we provide intensive weightmanagement programs and consultations. Our endocrine surgery services have seen tremendous clinical growth in the past few years. We continue to perform laparoscopic radiofrequency ablation on more patients with neuroendocrine metastatic disease to the liver than any other facility. Additionally, we are excited to offer a new program of laparoscopic liver resection. Our endocrine surgical fellowship program is the first of its kind in the country, and has been instrumental in facilitating clinical growth and educational activities within the program.

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Outcomes 2008

Thyroid and parathyroid cases have tripled in volume since 2001. Additionally, referrals of patients with complex conditions, including reoperative problems, advanced cancers and hereditary endocrine syndromes, are increasing. Our referral intake program efficiently reviews all cases before outpatient appointments, ensuring all required tests have been ordered. This streamlines appointments and has allowed for an increase in clinic-performed procedures such as ultrasound, fine needle aspiration and fiber-optic laryngoscopy. For patients with severe obesity, we provide bariatric surgery through minimally invasive approaches. Our ultimate goal for this patient population is the management of all degrees of obesity and its comorbidities. Bariatric surgeons, bariatricians, endocrinologists, psychologists, endocrine surgeons, nutritionists, gastroenterologists, cardiologists, internists, pediatricians and anesthesiologists are involved in patient care and research. We are one of only a few bariatric centers in the United States recognized by both the American Society for Metabolic and Bariatric Surgery and the American College of Surgeons as a Center of Excellence. This designation is awarded only after independent program review and demonstration of the highest quality in patient management and outcomes. Our state-of-the-art bariatric patient care facility was completely renovated in 2006 to better accommodate our patients. The facility includes an inpatient bariatric unit, an adjacent outpatient clinic, patient waiting rooms, a patient conference room, physician and support staff administrative offices and a new surgical endoscopy unit.

Endocrinology Total Patient Visits

19,143

New Patient Visits

738

Total Fine Needle Aspirations

575

Endocrine Surgery Total Surgeries

1,697

Total Major Surgeries: Thyroid / Parathyroid

1,047

Complex / Reoperative Surgeries

389

Bariatric Surgery Total Bariatric Cases

558

Bypass Surgeries

306

Lap Band Surgeries

89

Lap Sleeve Surgeries

86

Lap Gastric Bypass Mean Length of Stay (LOS)

3.5 days

Lap Adjustable Gastric Band Mean LOS

1.4 days

Research at our Bariatric and Metabolic Institute includes 26 active clinical and basic science studies that address a broad range of topics related to obesity and associated diseases. Educational highlights include our third annual Obesity Summit, with attendance of more than 300 physicians from throughout the United States.

Endocrinology & Metabolism Institute

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DiabetesOverview Surgical Patients’ HbA1c, LDL and Blood Pressure Rates Compared with NCQA* Averages (N = 1,055)





Q4 2005

Q4 2006

Q4 2007

Q4 2008

2007 NCQA Average(**)

HbA1c ≤ 7%

42%

43%

34%

38%

N/A(***)

HbA1c ≤ 8%

70%

68%

61%

63%

HbA1c > 9%

14%

14%

24%

22%

29%(****)

LDL Rate ≤ 100

67%

68%

60%

55%

47%

BP Control < 130/80

38%

39%

41%

45%

32%

Mean HbA1c dropped to normal in patients with diabetes after bariatric surgery.

* National Committee for Quality Assurance.

Figures show the percentages of diabetes patients at given levels of HbA1c, LDL cholesterol and blood pressure, compared with NCQA averages. Included are patients with diagnoses of diabetes mellitus of any type in our electronic medical records who were seen at least twice within the 12 months preceding the calendar quarter listed. Measures are their latest for each quarter.

Mean HbA1c in Patients with Type 2 Diabetes Mellitus before and after Bariatric Surgery (N = 37) 2007 – 2008 Percent 8 6

** http://www.ncqa.org/Portals/0/Newsroom/SOHC/SOHC_08.pdf. *** HbA1c < 7% is the recommended American Diabetes Association target for good glucose control. NCQA opted to remove this measure from public reporting in 2008. **** Lower rates are better for this measure.

4 2 0

Presurgery

Postsurgery

Thirty-seven percent of patients undergoing bariatric surgery had Type 2 diabetes mellitus. Among patients who had surgery in 2007 and follow-up visits in 2008 (N = 37), we compared means of the earliest HbA1c in 2007 and the last HbA1c in 2008.

8

Outcomes 2008

Diabetes Education Patients who received diabetes education (e.g., diabetes self-management education, nutrition counseling, survival skills and/or comprehensive group classes) in the Department of Endocrinology, Diabetes and Metabolism were evaluated for improvement in HbA1c at three and six months following their education sessions. They were compared with patients who were referred for education but did not attend. Mean Change in HbA1c in Diabetes Patients Who Attended Educational Sessions (N = 99)

Mean Change in HbA1c in Diabetes Patients Who Did Not Attend Educational Sessions (N = 52)

2008

2008

Percent Change - 0.0

Percent Change - 0.0

- 0.2

- 0.2

- 0.4

- 0.4

- 0.6

- 0.6

- 0.8

- 0.8

- 1.0

- 1.0

- 1.2

Baseline to 3 Months N = 81

Baseline to 6 Months N = 55

Patients who took the class had an average improvement of approximately 1.1 HbA1c percentage point from mean baseline, which was 8 percent. Most of those who participated in educational offerings attended one session. The majority of these patients had no diabetes medication changes or had their doses decreased during this period. Some were even taken off their diabetes medications completely because of improved blood glucose control. Nearly all of the patients reported high levels of satisfaction.

Endocrinology & Metabolism Institute

- 1.2

Baseline to 3 Months N = 37

Baseline to 6 Months N = 33

Patients who chose not to participate in educational offerings had an average HbA1c decrease of 0.5 percentage point from a mean baseline of 8.7 percent.

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Thyroid and Parathyroid Percent of Patients with Thyroid Cancer by Categories of Serum TSH* Values (N = 527) 2008 Percent of Total 80 60 40 20 0

< 0.4

0.4 - 0.99 1 - 2.49 Serum TSH Values

> 2.5

Of 930 established patients with thyroid cancer, 527 had at least one serum TSH value taken in 2008. The lowest TSH value achieved is shown. Our target for TSH suppression is less than 0.4 microunit/mL (normal range = 0.4-5.5). * Thyroid-stimulating hormone.

Cytology of Thyroid, Parathyroid and Cervical Lymph Node FNA Procedures (N = 575) 2008 Percent of Total 80 60 40 20 0

Benign

Limited Cellularity

Follicular Nondiagnostic Suspicious Neoplasm

Papillary Cancer

Fine Needle Aspiration (FNA) of Neck Masses 10

Outcomes 2008

Cleveland Clinic’s Endocrinology & Metabolism Institute performed 575 fine needle aspirations of neck masses in 2008. Some patients had FNA of more than one nodule at the same session. Twenty-eight patients had FNA of lymph nodes, and three patients had FNA of parathyroid masses. Of the total procedures, 4.3 percent were nondiagnostic. Likelihood of Confirming PTC* on Pathology when FNA was Positive for PTC (N = 20)

Likelihood of Finding Cancer on Pathology when FNA was Suspicious (N = 12)

2008

2008

Percent of Total 100

Percent of Total 80

80

60

60

40

40

20

20 0

PTC

No PTC Pathology Results

0

No Cancer Cancer Pathology Results

* Papillary thyroid cancer

* Papillary thyroid cancer.

All 20 patients with PTC cytology underwent thyroid surgery. The likelihood of confirming PTC on pathology when FNA was positive for PTC was 95 percent.

Endocrinology & Metabolism Institute

Twelve patients had suspicious cytology and underwent thyroid surgery. The probability of finding cancer on pathology when FNA was suspicious was 58 percent.

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Thyroid and Parathyroid Likelihood of Finding Cancer on Pathology when FNA Was Consistent with Follicular Neoplasm (N = 21) 2008 Percent of Patients 80 60 40 20 0

FTC*

PTC

No Cancer

Pathology Results * Follicular thyroid cancer.

Twenty-four patients had cytology consistent with follicular neoplasm, and 21 of them underwent surgery with final pathology. The likelihood of finding PTC and FTC on pathology when FNA was consistent with follicular neoplasm was 10 percent and 14 percent, respectively. Increase in Major, Complex and Reoperative Surgeries Number of Surgeries 1,200 Total Major Surgeries Thyroid and Parathyroid 1,000 Complex / Reoperative Surgeries 800 600 400 200 0

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

Referrals for major thyroid and parathyroid surgeries have been increasing, as have referrals for complex/reoperative surgeries. 12

Outcomes 2008

Pituitary Acromegaly Forty-nine patients with acromegaly were seen in the pituitary clinic in 2008.

Backgrounds of Radiation or No Radiation in Patients with Acromegaly (N = 49) 2008 Patients 30 25 20 15 10 5 0

No Radiation

Radiation

Twenty-three of the patients with acromegaly had histories of either conventional or Gamma Knife® radiation. All but three had pituitary surgery.

Endocrinology & Metabolism Institute

13

Pituitary Breakdown of Pharmacological Therapy for Patients with Acromegaly (N = 49)

Patients with Acromegaly Achieving Target GH* and IGF-1** (N = 36)

2008

2008

Number of Patients 25

Number of Patients 40

20

High IGF-1 Normal IGF-1

30

15

20

10 10

5 0

No Rx

SMS Analogues*

Pegvisomant

Combo

0

GH < 2.5 ng/mL GH > 2.5 ng/mL Growth Hormone Value

* Somatostatin analogues * Growth Hormone Twenty-nine patients were on SMS analogues, Pegvisomant or a combination of the two. ** Insulin-like growth factor-1 * Somatostatin analogues.

Twenty-nine patients were on SMS analogues, Pegvisomant or a combination of the two.

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* Growth hormone. ** Insulin-like growth factor 1.

Thirty-six patients were tested for serum GH and IGF-1. As a result of treatment, 21 patients achieved a target GH value of less than 2.5 ng/mL and a normal IGF-1. Serum GH values were not measured for patients treated with Pegvisomant.

Outcomes 2008

Liver Survival after Radiofrequency Ablation (RFA) of Colorectal Liver Metastases (N = 234) 1997 – 2006 Percent Survival 100 80 60 40 20 0

0

20

40 60 80 Months from Radiofrequency Ablation

100

A Kaplan-Meier survival curve of 234 patients undergoing radiofrequency ablation, with a median survival of 24 months.

Endocrine surgeons in Cleveland Clinic’s Endocrinology & Metabolism Institute assessed the factors affecting long-term survival of patients who had undergone RFA of colorectal hepatic metastases, with attention to evolving chemotherapy regimens. The results of this study comparing overall survival and median disease-free survival are encouraging. RFA demonstrates clear survival benefit for patients who are deemed inoperable and/or do not respond to systemic chemotherapy. Before local therapies, this subgroup of patients had virtually no survivors at five years, whereas our study demonstrates an 18.4 percent five-year survival rate. This study strongly suggests that control of local disease increases long-term survival.

Endocrinology & Metabolism Institute

15

Adrenal Comparison of Laparoscopic Transabdominal Lateral Vs. Posterior Retroperitoneal Adrenalectomy Since 1994, our surgeons have been performing laparoscopic adrenalectomies via the lateral transabdominal as well as the posterior retroperitoneal approach. Endocrine surgeons assessed patient selection criteria for each approach with comparison of perioperative outcomes. In patients with smaller tumors, low body mass index, history of previous abdominal operations, appropriate body habitus and bilateral pathology, the posterior approach was preferentially performed. Data regarding clinical pathology, tumor size, body mass index, estimated blood loss, operating time, morbidity, mortality and length of stay (LOS) were analyzed retrospectively. Our data shows that the lateral and posterior techniques have similar perioperative outcomes when patients are selected for each option based on certain criteria.

Adrenalectomy Approaches (N = 159) 1994 – 2008 Percent of Patients 60 50

Bilateral Unilateral

40 30 20 10 0

Lateral

Posterior Surgical Approach

Between 1994 and 2008, we performed 172 laparoscopic adrenalectomies on 159 patients, using both lateral and posterior surgical approaches. Bilateral Adrenalectomy Approaches (N = 13) 1994 – 2008 Percent of Patients 80 60 40 20 0

Lateral

Posterior Surgical Approach

In bilateral adrenalectomies performed on 13 patients, surgeons in the Endocrinology & Metabolism Institute used the posterior approach more than twice as often as the lateral approach. 16

Outcomes 2008

Adrenalectomy Approach by Average Body Mass Index (BMI) (N = 172 adrenals in 159 patients)

Laparoscopic Adrenalectomy Average LOS by Surgical Approach (N = 159)

1994 – 2008

1994 – 2008

BMI (kg/m2) 34

100

Percent of Patients >2 days 2 days 1 day

80

32

60 30

40

28 26

20 Lateral Posterior Surgical Approach

The lateral approach was preferred for patients with higher BMI. Adrenalectomy Approaches for Tumor Size > 6 cm (N = 12)

0

Lateral Posterior Surgical Approach

Average lengths of stay were shorter for patients who underwent posterior procedures. Two patients who had lateral adrenalectomies died postoperatively of cardiac or pulmonary causes. Two patients in the posterior group developed temporary neuralgia.

1994 – 2008 Percent of Procedures 20 15 10 5 0

Lateral

N = 11

Posterior N=1

Surgical Approach

Sixteen percent of the 172 adrenalectomies involved tumors larger than 6 centimeters in diameter. The lateral approach was preferred for patients with tumors of this size.

Endocrinology & Metabolism Institute

17

Obesity/Metabolism Number of High-Risk and Super-Obese Patients and Revisional Procedures (N = 523)

Cleveland Clinic Bariatric and Metabolic Institute (BMI) has been designated a Bariatric Surgery Center of Excellence by the American Society for Metabolic and Bariatric Surgery and the American College of Surgeons. This designation is awarded to programs that meet high-quality standards and perform a minimum of 125 procedures annually. In 2008, BMI case volume was more than four times the Center of Excellence volume requirement.

2008 Number of Patients 600 500 400 300

Bariatric Cases by Type

200

Number of Procedures

100

600

0

Other Revisions Sleeve Band Bypass

500 400 300 200 100 0

2004

2005

2006

2007

2008

N = 111

N = 248

N = 326

N = 409

N = 558

Laparoscopic Roux-en-Y gastric bypass, revisional procedures, laparoscopic adjustable gastric banding and laparoscopic sleeve gastrectomy are the most common bariatric operations performed at Cleveland Clinic.

18

35%

31% 8%

High Risk

Super Obese

Revisional Surgeries

Cleveland Clinic continues to be a referral center for high-risk bariatric patients requiring specialty care. The average preoperative body mass index for all patients in our surgical program in 2008 was 47.9 kg/m2. Thirty-five percent of our primary bariatric surgical cases involved high-risk patients (body mass index greater than 55 or age 60 and over), and 31 percent were super-obese (body mass index greater than 50). Referrals for revisional bariatric surgery represented about 8 percent of bariatric cases in 2008. Occasionally, bariatric operations require revisions due to surgical complications such as fistulas, obstructions, ulcers, severe reflux, band slippage and weight regain related to gastric pouch dilation or ineffective gastric bands.

Outcomes 2008

Bariatric Procedures Requiring ICU Stays

16 – 77 —

2008

Age range of bariatric patients in 2008.

Percent 5 4

122 — Highest body mass

3 2

index in a patient treated in 2008. N = 7 Patients N = 1 Patient

1 0

More than 98 — Lap Gastric Bypass N = 283

Lap Adjustable Gastric Band N = 81

Approximately 2 percent of laparoscopic Roux-en-Y gastric bypass and 1 percent of gastric band patients required postoperative ICU stays, despite the relatively high-risk patient population.

Percentage of bariatric surgeries performed at Cleveland Clinic using minimally invasive techniques.

Procedure Length of Stay 2008 Days 5 4 3 2

N = 7 Patients N = 1 Patient

1 0

Lap Gastric Bypass N = 283

Lap Adjustable Gastric Band N = 81

More than 98 percent of bariatric cases are performed laparoscopically. The mean length of stay for Roux-en-Y gastric bypass procedures is 3.5 days; and for the adjustable gastric band, 1.4 days. Endocrinology & Metabolism Institute

19

Obesity/Metabolism Laparoscopic Procedure 30-Day Mortality 2008 Days 5 4 3 2 1 0

0%

Lap Adjustable Gastric Band N = 89

Lap Gastric Bypass N = 306

Lap Sleeve Gastrectomy

Revisions N = 42

N = 86

Postoperative mortality at 30 days was 0 percent for gastric band procedures, 0.3 percent for primary laparoscopic Roux-en-Y gastric bypass procedures, 1.1 percent for laparoscopic sleeve gastrectomies and 2.4 percent for revisional bariatric procedures. Major Complications 2008 Percent of Procedures 10 8 6 4 2 0

Lap Gastric Bypass (N = 306)

Lap Adjustable Gastric Band (N = 89)

Overall major complication rates were less than 9 percent for laparoscopic Roux-en-Y gastric bypass and approximately 1 percent for laparoscopic adjustable gastric banding. Approximately 35 percent of patients were considered high risk due to advanced age, high body mass index and high comorbidity burden. Major complications include any complication resulting in increased hospital stay by two or more days, rehospitalization or surgical intervention. 20

Outcomes 2008

Roux-en-Y Gastric Bypass Patients with Major Complications (N = 306) 2008 Percent of Cases 5 4 3 2 1 0

Wound Infections

Bleed (Requiring Transfusion)

Anastomotic Anastomotic Stricture Leak

Bowel Obstruction

Abscess

DVT

Pulmonary Embolism

Complications of gastric bypass were relatively low, considering approximately 35 percent of these patients were high risk. Leapfrog Survey - Bariatric Surgery Quality of Care January – December 2007 Progress towards meeting Leapfrog Standards* One bar = willing to report data Two bars = some progress Three bars = substantial progress Four bars = fully meets standards

The Leapfrog Group aims to reduce preventable medical mistakes and improve the quality and affordability of health care. Participation in the annual Leapfrog Quality and Safety Survey is voluntary. Cleveland Clinic’s bariatric surgery rating appears above. *Source http://www.leapfroggroup.org/

Endocrinology & Metabolism Institute

21

Obesity/Metabolism Weight Loss 18 Months or Greater Post-Bariatric Surgery (N = 198)

Binge Eating

2008

The Binge Eating Group is conducted by the BMI Behavioral Health. It is designed for bariatric surgery patients who reported behaviors consistent with Binge Eating Disorder (BED). BED has been associated with poorer surgery outcomes, including weight regain, and is thus an important factor to assess and treat for , bariatric surgery patients.* ** Patients are routinely given the Binge Eating Scale (BES)*** at their initial assessment by their BMI psychologist. Patients with elevated scores, those who meet criteria for BED or those who demonstrate other binge eating behaviors are referred to the Binge Eating Group. The Binge Eating Group is a cognitive behavioral treatment including elements of self-monitoring, stimulus control, cognitive restructuring, body image processing, stress management and relaxation training, and group support. The BES and the number of binges per week are then routinely assessed at the end of the four-week group to determine treatment progress.

Percent 100 50% Excess Weight Loss

Excess Weight Loss

Approximately 60 percent of patients who are approximately two years and greater postoperatively lost at least 50 percent of their excess weight (based on normal body mass index of 25 kg/m2).

22

Outcomes 2008

Patient Binge Eating before and after Binge Eating Therapy (N = 168) 2008 Number 25 Before Treatment After Treatment

20 15 10 5 0

Average BES

Average Number of Binge Eating Episodes

From 2007 to 2008, participation in the group doubled, going from 81 patients to 170 patients. Of participants, 82 percent were female. The graph shows that among 168 patients for whom data is available, the average score on the BES was significantly reduced following the group treatment (P < .001). The average number of binge eating episodes per week also decreased following group treatment (P < .001). Average patient satisfaction was 4.34 on a scale of 1 (extremely dissatisfied) to 5 (extremely satisfied). * Guisado Macias JA, Vaz Leal FJ. Psychopathological differences between morbidly obese binge eaters and non-binge eaters after bariatric surgery. Eat Weight Disord. 2003 Dec;8(4):315-318.

60 – Percentage of patients who achieved more than 50% excess weight loss in 18 months or longer after bariatric surgery.

** Hsu LK, Benotti PN, Dwyer J, Roberts SB, Saltzman E, Shikora S, Rolls BJ, Rand W. Nonsurgical factors that influence the outcome of bariatric surgery: a review. Psychosom Med. 1998 MayJun;60(3):338-346. *** Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55.

Endocrinology & Metabolism Institute

23

Surgical Quality Improvement Hospital Compare is a consumer-oriented website hosted by the Centers for Medicare & Medicaid Services (CMS) in collaboration with the Hospital Quality Alliance (HQA). Hospitals that have agreed to public reporting submit process-of-care data showing how consistently they provide recommended care to adult patients, irrespective of payer. (These results also are posted on The Joint Commission’s website.) Thirty-day risk-adjusted all-cause mortality rates are outcomes based on Medicare claims and enrollment information. Cleveland Clinic’s 2008 surgical care performance appears below. SCIP - Prophylactic Antibiotic Received within 1 Hour Prior to Surgical Incision (N = 902) Discharges January – December 2008

National Average*

86

Cleveland Clinic

95

0

20

40

60

80

100

Percent of Patients * Source: www.hospitalcompare.hhs.gov, discharges July 2007- June 2008

24

Outcomes 2008

SCIP - Prophylactic Antibiotic Discontinued within 24 Hours After Surgery End Time (N = 813) Discharges January – December 2008

National Average*

84

Cleveland Clinic

82

0

20

40

60

80

100

Percent of Patients * Source: www.hospitalcompare.hhs.gov, discharges July 2007- June 2008

SCIP - Appropriate Prophylactic Antibiotic Selection for Surgical Patients (N = 937) Discharges January – December 2008

National Average*

92

Cleveland Clinic

95

0

20

40

60

80

100

Percent of Patients * Source: www.hospitalcompare.hhs.gov, discharges July 2007- June 2008

Endocrinology & Metabolism Institute

25

Surgical Quality Improvement SCIP - Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered (N = 677) Discharges January – December 2008

National Average*

84

Cleveland Clinic

96

0

20

40

60

80

100

Percent of Patients * Source: www.hospitalcompare.hhs.gov, discharges July 2007- June 2008

SCIP - Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis within 24 Hours Prior to Surgery to 24 Hours after Surgery (N = 677) Discharges January – December 2008

National Average*

81

Cleveland Clinic

95

0

20

40

60

80

100

Percent of Patients * Source: www.hospitalcompare.hhs.gov, discharges July 2007- June 2008

26

Outcomes 2008

SCIP - Surgery Patients with Appropriate Hair Removal (N = 1,386) Discharges January – December 2008

National Average*

95

Cleveland Clinic

94

0

20

40

60

80

100

Percent of Patients * Source: www.hospitalcompare.hhs.gov, discharges January - June 2008

Endocrinology & Metabolism Institute

27

Patient Experience Cleveland Clinic has placed a renewed emphasis on improving the patient experience by establishing the role of Chief Experience Officer. Recognizing that patients seek more than solely a successful clinical outcome, the mission of the Office of Patient Experience is to create an environment that enhances the well-being of our patients, families and employees in a way that elevates Cleveland Clinic’s reputation as one of the world’s best hospitals. In 2008, the Office of Patient Experience dedicated teams within the institutes to research and implement innovative patient- and family-based programs that support this mission.

Outpatient – Endocrinology & Metabolism Institute Overall Rating of Outpatient Care and Services 2007 – 2008 Percent 100 2007 (N = 761) 2008 (N = 931)

80 60 40 20 0

Excellent

Very Good

Good

Fair

Poor

Source: Quality Data Management, a national hospital survey vendor

28

Outcomes 2008

Rating of Outpatient Provider 2007 – 2008 Percent 100 2007 (N = 761) 2008 (N = 931)

80 60 40 20 0

Excellent

Very Good

Good

Fair

Poor

Source: Quality Data Management, a national hospital survey vendor

Recommend Outpatient Provider 2007 – 2008 Percent 100 2007 (N = 761) 2008 (N = 931)

80 60 40 20 0

Extremely Likely

Very Likely

Somewhat Likely

Somewhat Unlikely

Very Unlikely

Source: Quality Data Management, a national hospital survey vendor

Endocrinology & Metabolism Institute

29

Patient Experience Inpatient – Endocrinology & Metabolism Institute With the support of the Centers for Medicare and Medicaid Services (CMS) and its partner organizations, the first national standard patient experience hospital survey (HCAHPS) was implemented in late 2006. Results collected for reporting are available at www.hospitalcompare.hhs.gov.

HCAHPS Overall Assessment 2007 – 2008 Percent 100

2007 total survey respondents = 223 2008 total survey respondents = 313

80 60

59%

64%

67%

73%

40 20 0

Rate Hospital

Would Recommend

% respondents choosing 9 or 10

% respondents choosing 'definitely yes'

Source: Quality Data Management and Press Ganey, national hospital survey vendors For comparison purposes, 2007 and Q1 2008 HCAHPS scores have been adjusted to account for a survey mode administration change as recommended by CMS.

30

Outcomes 2008

80

2008 (n=316)

60 40 20 0

Discharge Information

Nurse Communication Doctor Pain Communication Management

Room Clean

Responsiveness to Needs

Communication New Medications

Quiet at Night

Source: Quality Data Management and Press Ganey, national hospital survey vendors. For comparison purposes, 2007 and Q1 2008 HCAHPS scores have been adjusted to account for a survey mode administration change as recommended by CMS.

HCAHPS Domains of Care 2007 – 2008 Respondents choosing 'always' or 'yes'

Percent 100

2007 total survey respondents = 223 2008 total survey respondents = 313

80 60 40 20 0

Discharge Information

Doctor Communication

Nurse Communication

Pain Management

Room Clean

Communication Responsiveness New Medications to Needs

Quiet at Night

Source: Quality Data Management and Press Ganey, national hospital survey vendors For comparison purposes, 2007 and Q1 2008 HCAHPS scores have been adjusted to account for a survey mode administration change as recommended by CMS.

Endocrinology & Metabolism Institute

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Patient Experience Patient Total Time in Clinic Decreases for Bariatric and Metabolic Institute The Bariatric and Metabolic Institute, named a Center of Excellence in 2006 (a three-year designation) by the American Society for Metabolic and Bariatric Surgery and the American College of Surgeons, saw its caseload quintuple — from 100 patients in 2004 to more than 500 in 2008. But with only 35 percent of outpatients spending less than two hours per visit in early 2008, the institute resolved to do better. A team of surgeons, nurses, managers, analysts and researchers set about increasing the number of patients spending less than two hours total in the outpatient clinic. Using the FasTrac™ collaborative problem-solving tool, the team reduced patients’ total time in the clinic from an average of two hours and 40 minutes to one hour and 49 minutes at the end of the year — a drop of 32 percent. From June through December, the improvements made through FasTrac enabled the physicians to improve their efficiency in clinic by 27 percent. Patients noticed the change: Results from a national patient experience survey vendor showed 77 percent felt the wait time was excellent or very good in the fourth quarter, compared with 41 percent who felt that way in the second quarter.

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Average Patient Time in Bariatric and Metabolic Institute Outpatient Clinic (N = 573) 2008 Hours:Minutes 4:19 3:50 3:21 2:52 2:24 1:55 1:26 0:57 0:28 0:00 June July

Physician A Physician B Physician C

September October November December

Average time patients spent in the Bariatric and Metabolic Institute outpatient clinic dropped from two hours and 40 minutes to one hour and 49 minutes. (Data not available for August.)

Outcomes 2008

Bariatric Surgery Anesthesia Patient Satisfaction with Anesthesia Care for Bariatric Surgery (N = 260 )

77 — Percentage of patients who

2008

reported the wait time was Percent 100

excellent or very good in the fourth quarter, compared with 41 percent in second quarter.

95 90 85 80 Q1 N = 69

Q2 N = 71

Q3 N = 68

Q4 N = 52

Representatives of the Anesthesiology Institute visit each bariatric surgery inpatient on his or her second postoperative day in the hospital to evaluate the early postoperative period. A question in the interview during these postoperative rounds asks for the patient’s response to the statement, “I was satisfied with my anesthesia care.” The percentages by calendar quarter of bariatric surgery patients responding “Agree very much,” the highest rating, or “Agree moderately” are shown.

Endocrinology & Metabolism Institute

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Innovations Liver

Adrenal

Laparoscopic Liver Resection

Laparoscopic Radiofrequency Ablation (RFA) of Adrenal Tumors

Over the last year, Cleveland Clinic Endocrinology & Metabolism Institute (EMI) surgeons have developed techniques for laparoscopic liver resection, a procedure that enables removal of liver tumors through small incisions in the abdomen. The initial results of a study of this procedure were presented nationally in 2008 and published in a distinguished journal. In this study, EMI surgeons reported that the laparoscopic technique, in appropriate patients, results in less operative blood loss, fewer analgesic requirements, quicker advance to a regular diet, and decreased hospital stay and overall cost compared with conventional open liver resection.

Some patients are not candidates for adrenalectomy due to unresectable cancer or medical comorbidities that preclude a long anesthesia time. The endocrine surgery team has applied laparoscopic RFA for the management of such patients. To date, three patients with adrenal malignancies and one patient with an enlarging benign adenoma have received this new treatment, without complications. This is the first laparoscopic RFA experience in the world for managing adrenal tumors.

Cleveland Clinic’s Robotic Liver Resection In line with the laparoscopic liver resection program, the EMI surgeons have started a robotic liver resection program. The use of the robot increases dexterity and versatility in laparoscopic procedures. Four patients have undergone robotic liver resection to date, all with good results.

endocrine surgery team pioneered the use of laparoscopic RFA for managing adrenal tumors.



Adrenal gland before (left) and after laparoscopic RFA

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Outcomes 2008

Thyroid Thyroid-Stimulating Hormone Receptor (TSHR) mRNA Assay Steps Since 2001, we have studied the clinical applications of detecting TSHR mRNA in circulation. This marker was developed at Cleveland Clinic, and represents a novel diagnostic tool in that it detects circulating thyroid cancer cells, rather than thyroidrelated proteins or hormones. It is undetectable in people who have normal thyroids and can distinguish among patients who have benign thyroid disease and initial and recurrent thyroid cancer. After multiple clinical studies, TSHR mRNA became a routinely available clinical test in 2008, offered to patients locally, nationally and internationally. Cleveland Clinic has the only specialized reference lab to provide this test. In a new series of more than 250 patients, we were able to validate that (1) TSHR mRNA is a useful marker of thyroid cancer, (2) it complements neck ultrasound in determining which patients with follicular neoplasms have malignancy and which can potentially avoid surgery and (3) TSHR mRNA becomes an important marker, particularly when other modalities fail, in long-term surveillance to detect thyroid cancer recurrences. Peripheral blood-based reverse transcriptase PCR. Thyroid-stimulating hormone receptor. Cleveland Clinic has the only specialized reference lab that offers a clinical test for detecting the cancer marker TSHR mRNA in circulation.

*Barbosa GF, Milas M. Peripheral thyrotropin receptor mRNA as a novel marker for differentiated thyroid cancer diagnosis and surveillance. Expert Rev Anticancer Ther. 2008 Sep;8(9):1415-1424.

Endocrinology & Metabolism Institute

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Innovations Parathyroid/Calcium/Osteoporosis

Increase in Number of Men with Preoperative DXA* Scans

Osteoporosis in Men

N = 81

Primary hyperparathyroidism is a strong risk factor for bone disease. Results of a study undertaken by endocrine surgeons at Cleveland Clinic indicated that this association has been underappreciated in men. The surgeons found that men were much less likely than women to undergo bone density screening, even when diagnosed with primary hyperparathyroidism. The endocrine surgeons instituted a protocol to require bone density screening as part of the initial evaluations of their patients with hyperparathyroidism, and followed bone density results after parathyroid surgery. After several years of this practice improvement, data show valuable outcomes. With these improved screening practices, the surgeons were able to determine that the prevalence of osteoporosis in this population of men with primary hyperparathyroidism was very similar to that of women, a finding not previously recognized. The research also showed bone density improved substantially more in men than in women following parathyroid surgery. This research was important because it improved the clinical care of patients with hyperparathyroidism and highlighted newly recognized benefits of surgery for hyperparathyroidism in men.

Patients 30

36

20

10

0

2000

2001

2002

2003

2004

2005

2006

*Dual energy x-ray absorptiometry The number of men referred for parathyroidectomy who underwent DXA screening increased over a seven-year period. This increase reflects, in part, a deliberate attempt to screen men more aggressively for bone disease, following a trend already set forth in women.

Outcomes 2008

Comparison of DXA Screening and Bone Disease Prevalence among Women and Men N = 1,000 (757 Women and 243 Men) Percent 100 80 60 40 20 0

Women

Men

Women

2000

Men 2005

Percentage of patients in total cohort given DXA scan Detection of bone disease among patients screened Detection of bone disease within total cohort

Among both sexes referred for parathyroidectomy, the percentage of patients with DXA scans rose from 2000 to 2005, with a substantial increase in the percentage of men undergoing DXA scanning. Aggressive screening increased the apparent prevalence of bone disease among men from deceptively low levels in 2000 to levels approaching those observed in the female cohort in 2005.

Endocrinology & Metabolism Institute

Obesity/Metabolism BLIS Surgical Complication Insurance In 2008, the Bariatric and Metabolic Institute started offering a financial guarantee for bariatric (weight loss) procedures. Because our surgeons have favorable track records with clinical outcomes, we are able to provide BLIS surgical complication insurance, or a financial guarantee, to all self-pay patients. The BLIS insurance product financially protects both the patient and the hospital from unforeseen bariatric complications that can lead to unexpected medical bills. BLIS offers peace of mind regarding additional medical costs in the event complications occur. Bariatric Multidisciplinary Rounds Occasionally, patients seeking bariatric surgery have both high-risk medical comorbidities and psychological concerns. Bariatric and Metabolic Institute surgeons, psychologists, nurses, registered dietitians and other support staff hold monthly multidisciplinary rounds, during which they review each patient’s medical history and psychosocial background, along with the risks and benefits of bariatric surgery. The team then determines whether the patient should pursue a surgical or behavioral therapeutic pathway.

37

Innovations Preliminary results

Gastric Plication Procedure for Severe Obesity

suggest that gastric

Bariatric and Metabolic Institute surgeons have been developing a less invasive surgical procedure for longterm weight loss. Like other bariatric operations, gastric plication causes weight loss by reducing stomach capacity, which causes earlier satiety and thus limits calorie intake. The procedure specifically involves invagination of the anterior or lateral wall of the stomach inside the gastric lumen to reduce gastric volume. This is accomplished by suturing the gastric wall together, using a laparoscopic approach.

plication produces weight loss comparable to that achieved with more invasive procedures.

Gastric plication offers important advantages over other bariatric procedures in that it involves no stapling, cutting or removal of tissue. Therefore, it is minimally invasive and can be performed in an outpatient setting. It also can be easily reversed. Preliminary results suggest that weight loss is comparable to the loss experienced in existing, more invasive procedures, while the procedure offers minimal risk and quick recovery. Gastric plication is a promising concept that will be under further development at Cleveland Clinic and may be available to patients in the next few years.

Gastric volume reduction by vertical gastric plication

38

Outcomes 2008

Determining Candidacy for Bariatric Surgery: Moving Beyond Dichotomous Psychological Evaluation Most bariatric programs and insurers require presurgical psychological evaluations. The criteria for such decision-making and acceptance rates have been well described; however, most programs make dichotomous distinctions or include a “waiting” category. Cleveland Clinic Behavioral Health Services Psychology developed and explored the feasibility of an empirically based multidimensional psychological determination process. Bariatric surgery candidates (N = 464) were evaluated across eight domains drawn from the psychosocial bariatric literature: 1) capacity to consent, 2) expectations, 3) mental health, 4) eating behaviors/disorders, 5) substance use/abuse/ dependence, 6) social support, 7) adherence and 8) coping and stressors. Each domain was graded on a five-point scale ranging from poor to excellent. A summary assessment of poor, guarded, fair, good or excellent was also given. Most candidates were deemed acceptable, but 25.7 percent were initially considered guarded or poor candidates. Only 2.6 percent of the sample was unable to achieve goals to improve their candidacies and have surgery. Hierarchical regression analyses on summary assessments were conducted to identify factors that may predict poorer candidacy ratings. The model proposed explained 30 percent of the variance in candidacy scores. Variables most strongly associated with lower assessments were: unemployment, less education, higher body mass index, current smoking and number of psychiatric medications. Such variables are being further evaluated for predictive validity and may be important in screening candidates.

Endocrinology & Metabolism Institute

39

Selected Publications

The Endocrinology & Metabolism Institute staff authored

84 publications in 2008 — one book, four book chapters and 79 journal articles.

Abraham WT, Fonarow GC, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O’Connor CM, Sun JL, Yancy CW, Young JB. Predictors of in-hospital mortality in patients hospitalized for heart failure: insights from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). J Am Coll Cardiol. 2008 Jul 29;52(5):347-356. Ahmed A, Young JB, Love TE, Levesque R, Pitt B. A propensity-matched study of the effects of chronic diuretic therapy on mortality and hospitalization in older adults with heart failure. Int J Cardiol. 2008 Apr 10;125(2):246-253. Angheloiu GO, Rahaby M, Starling RC, Angheloiu V, McNamara DM, Yamani MH, Young JB. Myocardial degradation and left bundle branch block predict conversion to low ejection fraction in heart failure with preserved systolic function. Congest Heart Fail. 2008 Jul;14(4):192-196. Baliga RR, Young JB. “Stiff central arteries” syndrome: does a weak heart really stiff the kidney? Heart Fail Clin. 2008 Oct;4(4):ix-xii. Baliga RR, Young JB. Editorial: The concertina pump. Heart Fail Clin. 2008 Jul;4(3):xiii-xix. Baliga RR, Young JB. Energizing diastole. Heart Fail Clin. 2008 Jan;4(1):ix-xiii. Baliga RR, Young JB. Statins or status quo? Heart Fail Clin. 2008 Apr;4(2):ix-xii. Ballem N, Greene AB, Parikh RT, Berber E, Siperstein A, Milas M. Appreciation of osteoporosis among men with hyperparathyroidism. Endocr Pract. 2008 Oct;14(7):820-831. Ballem N, Berber E, Pitt T, Siperstein A. Laparoscopic radiofrequency ablation of unresectable hepatocellular carcinoma: long-term follow-up. HPB (Oxford). 2008;10(5):315-320.

40

Outcomes 2008

Ballem N, Parikh R, Berber E, Siperstein A. Laparoscopic versus open ventral hernia repairs: 5 year recurrence rates. Surg Endosc. 2008 Sep;22(9):1935-1940.

Canes D, Aron M, Nguyen MM, Winans C, Chand B, Gill IS. Common bile duct injury during urologic laparoscopy. J Endourol. 2008 Jul;22(7):1483-1484.

Bantle JP, Wylie-Rosett J, Albright AL, Apovian CM, Clark NG, Franz MJ, Hoogwerf BJ, Lichtenstein AH, Mayer-Davis E, Mooradian AD, Wheeler ML. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008 Jan;31 Suppl 1:S61-S78.

Cho L, Hoogwerf B, Huang J, Brennan DM, Hazen SL. Gender differences in utilization of effective cardiovascular secondary prevention: a Cleveland Clinic prevention database study. J Womens Health (Larchmt ). 2008 May;17(4):515-521.

Barbosa GF, Milas M. Peripheral thyrotropin receptor mRNA as a novel marker for differentiated thyroid cancer diagnosis and surveillance. Expert Rev Anticancer Ther. 2008 Sep;8(9):1415-1424. Berber E, Parikh RT, Ballem N, Garner CN, Milas M, Siperstein AE. Factors contributing to negative parathyroid localization: an analysis of 1000 patients. Surgery. 2008 Jul;144(1):74-79. Berber E, Siperstein A. Local recurrence after laparoscopic radiofrequency ablation of liver tumors: an analysis of 1032 tumors. Ann Surg Oncol. 2008 Oct;15(10):2757-2764. Berber E, Siperstein A. Radiofrequency (RF)-assisted hepatectomy may induce severe liver damage. World J Surg. 2008 Aug;32(8):1897-1898. Berber E, Tsinberg M, Tellioglu G, Simpfendorfer CH, Siperstein AE. Resection versus laparoscopic radiofrequency thermal ablation of solitary colorectal liver metastasis. J Gastrointest Surg. 2008 Nov;12(11):1967-1972. Brethauer SA, Chao A, Chambers LW, Green DJ, Brown C, Rhee P, Bohman HR. Invasion vs insurgency: US Navy/Marine Corps forward surgical care during Operation Iraqi Freedom. Arch Surg. 2008 Jun;143(6):564-569. Callahan TD, Khokhar U, Pozuelo L, Young JB. Case study in heart-brain interplay: a 53-year-old woman recovering from mitral valve repair. Cleve Clin J Med. 2008 Mar;75 Suppl 2:S10-S14.

Endocrinology & Metabolism Institute

Coletta DK, Balas B, Chavez AO, Baig M, Abdul-Ghani M, Kashyap SR, Folli F, Tripathy D, Mandarino LJ, Cornell JE, Defronzo RA, Jenkinson CP. Effect of acute physiological hyperinsulinemia on gene expression in human skeletal muscle in vivo. Am J Physiol Endocrinol Metab. 2008 May;294(5):E910-E917. Cooley DA, Fung JJ, Young JB, Starzl TE, Siegler M, Chen PW. Transplant innovation and ethical challenges: what have we learned? A collection of perspectives and panel discussion. Cleve Clin J Med. 2008 Nov;75 Suppl 6:S24-S29. Cooper JD, Clayman RV, Krummel TM, Schauer PR, Thompson C, Moreno JD. Inside the operating room— balancing the risks and benefits of new surgical procedures: a collection of perspectives and panel discussion. Cleve Clin J Med. 2008 Nov;75 Suppl 6:S37-S48. Crouzet S, Haber GP, Kamoi K, Berger A, Brethauer S, Gatmaitan P, Gill IS, Kaouk JH. Natural orifice translumenal endoscopic surgery (NOTES) renal cryoablation in a porcine model. BJU Int. 2008 Dec;102(11):1715-1718. Davidson MB, Wong A, Hamrahian AH, Stevens M, Siraj ES. Effect of spironolactone therapy on albuminuria in patients with type 2 diabetes treated with Angiotensin-converting enzyme inhibitors. Endocr Pract. 2008 Nov;14(8):985-992.

41

Selected Publications Diab DL, Yerian L, Schauer P, Kashyap SR, Lopez R, Hazen SL, Feldstein AE. Cytokeratin 18 fragment levels as a noninvasive biomarker for nonalcoholic steatohepatitis in bariatric surgery patients. Clin Gastroenterol Hepatol. 2008 Nov;6(11):1249-1254. Diab DL, Faiman C, Siperstein AE, Zhou M, Zimmerman RS. Virilizing adrenal ganglioneuroma in a woman with subclinical Cushing syndrome. Endocr Pract. 2008 Jul;14(5):584-587. Diab DL, Faiman C, Siperstein AE, Grossman WF, Rabinowitz LO, Hamrahian AH. Virilizing ovarian Leydig cell tumor in a woman with subclinical Cushing syndrome. Endocr Pract. 2008 Apr;14(3):358-361. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O’Connor CM, Nunez E, Yancy CW, Young JB. A smoker’s paradox in patients hospitalized for heart failure: findings from OPTIMIZE-HF. Eur Heart J. 2008 Aug;29(16):1983-1991. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O’Connor CM, Sun JL, Yancy CW, Young JB. Dosing of beta-blocker therapy before, during, and after hospitalization for heart failure (from Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure). Am J Cardiol. 2008 Dec 1;102(11):1524-1529. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O’Connor CM, Pieper K, Sun JL, Yancy CW, Young JB. Factors identified as precipitating hospital admissions for heart failure and clinical outcomes: findings from OPTIMIZE-HF. Arch Intern Med. 2008 Apr 28;168(8):847-854.

42

Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O’Connor CM, Sun JL, Yancy CW, Young JB. Influence of beta-blocker continuation or withdrawal on outcomes in patients hospitalized with heart failure: findings from the OPTIMIZE-HF program. J Am Coll Cardiol. 2008 Jul 15;52(3):190-199. Giamouzis G, Sui X, Love TE, Butler J, Young JB, Ahmed A. A propensity-matched study of the association of cardiothoracic ratio with morbidity and mortality in chronic heart failure. Am J Cardiol. 2008 Feb 1;101(3):343-347. Hadji P, Minne H, Pfeifer M, Bourgeois P, Fardellone P, Licata A, Devas V, Masanauskaite D, Barrett-Connor E. Treatment preference for monthly oral ibandronate and weekly oral alendronate in women with postmenopausal osteoporosis: A randomized, crossover study (BALTO II). Joint Bone Spine. 2008 May;75(3):303-310. Hoercher KJ, Nowicki ER, Blackstone EH, Singh G, Alster JM, Gonzalez-Stawinski GV, Starling RC, Young JB, Smedira NG. Prognosis of patients removed from a transplant waiting list for medical improvement: implications for organ allocation and transplantation for status 2 patients. J Thorac Cardiovasc Surg. 2008 May;135(5):1159-1166. Hoogwerf BJ, Doshi KB, Diab D. Pramlintide, the synthetic analogue of amylin: physiology, pathophysiology, and effects on glycemic control, body weight, and selected biomarkers of vascular risk. Vasc Health Risk Manag. 2008;4(2):355-362. Ioachimescu AG, Bauer TW, Licata A. Active Crohn disease and hypercalcemia treated with infliximab: case report and literature review. Endocr Pract. 2008 Jan;14(1):87-92. Ioachimescu AG, Hoogwerf BJ. Comments on the letter by Pitocco et al. (Serum uric acid, mortality and glucose control in patients with Type 2 diabetes mellitus: a PreCIS database study). Diabet Med. 2008 Apr;25(4):509.

Outcomes 2008

Ioachimescu AG, Brennan DM, Hoogwerf BJ. Reply [Serum uric acid level reduction, cardiovascular outcome, and mortality]. Arthritis Rheum. 2008 Aug;58(8):2586. Ioachimescu AG, Brennan DM, Hoar BM, Hazen SL, Hoogwerf BJ. Serum uric acid is an independent predictor of all-cause mortality in patients at high risk of cardiovascular disease: a preventive cardiology information system (PreCIS) database cohort study. Arthritis Rheum. 2008 Feb;58(2):623-630. Kashyap SR, Lara A, Zhang R, Park YM, Defronzo RA. Insulin reduces plasma arginase activity in type 2 diabetic patients. Diabetes Care. 2008 Jan;31(1):134-139. Kaw R, Aboussouan L, Auckley D, Bae C, Gugliotti D, Grant P, Jaber W, Schauer P, Sessler D. Challenges in pulmonary risk assessment and perioperative management in bariatric surgery patients. Obes Surg. 2008 Jan;18(1):134-138. Kirklin JK, Naftel DC, Stevenson LW, Kormos RL, Pagani FD, Miller MA, Ulisney K, Young JB. INTERMACS database for durable devices for circulatory support: first annual report. J Heart Lung Transplant. 2008 Oct;27(10):1065-1072. Kroh M, Chand B. Choledocholithiasis, endoscopic retrograde cholangiopancreatography, and laparoscopic common bile duct exploration. Surg Clin North Am. 2008 Oct;88(5):1019-1031. Kroh M, Hall R, Udomsawaengsup S, Smith A, Yerian L, Chand B. Endoscopic water jets used to ablate Barrett’s esophagus: Preliminary results of a new technique. Surg Endosc. 2008 Nov;22(11):2498-2502. Licata AA. Biochemical markers of bone turnover: useful but underused. Cleve Clin J Med. 2008 Oct;75(10):751-752. Lo HW, Stephenson L, Cao X, Milas M, Pollock R, Ali-Osman F. Identification and functional characterization of the human glutathione S-transferase P1 gene as a novel transcriptional target of the p53 tumor suppressor gene. Mol Cancer Res. 2008 May;6(5):843-850.

Endocrinology & Metabolism Institute

MacDonald MR, Petrie MC, Varyani F, Ostergren J, Michelson EL, Young JB, Solomon SD, Granger CB, Swedberg K, Yusuf S, Pfeffer MA, McMurray JJV. Impact of diabetes on outcomes in patients with low and preserved ejection fraction heart failure: an analysis of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme. Eur Heart J. 2008 Jun;29(11):1377-1385. Mascaro-Blanco A, Alvarez K, Yu X, Lindenfeld J, Olansky L, Lyons T, Duvall D, Heuser JS, Gosmanova A, Rubenstein CJ, Cooper LT, Kem DC, Cunningham MW. Consequences of unlocking the cardiac myosin molecule in human myocarditis and cardiomyopathies. Autoimmunity. 2008 Sep;41(6):442-453. Mazzaglia PJ, Berber E, Kovach A, Milas M, Esselstyn C, Siperstein AE. The changing presentation of hyperparathyroidism over 3 decades. Arch Surg. 2008 Mar;143(3):260-266. Meyer P, White M, Mujib M, Nozza A, Love TE, Aban I, Young JB, Wehrmacher WH, Ahmed A. Digoxin and reduction of heart failure hospitalization in chronic systolic and diastolic heart failure. Am J Cardiol. 2008 Dec 15;102(12):1681-1686. Mirza B, Chand B. Laparoscopic repair of ileal conduit parastomal hernia using the sling technique. JSLS. 2008 Apr-Jun;12(2):173-179. Mitchell J, Milas M, Barbosa G, Sutton J, Berber E, Siperstein A. Avoidable reoperations for thyroid and parathyroid surgery: Effect of hospital volume. Surgery. 2008 Dec;144(6):899-907. Mullens W, Abrahams Z, Sokos G, Francis GS, Starling RC, Young JB, Taylor DO, Tang WHW. Gender differences in patients admitted with advanced decompensated heart failure. Am J Cardiol. 2008 Aug 15;102(4):454-458. Mullens W, Abrahams Z, Skouri HN, Taylor DO, Starling RC, Francis GS, Young JB, Tang WHW. Prognostic evaluation of ambulatory patients with advanced heart failure. Am J Cardiol. 2008 May 1;101(9):1297-1302. 43

Selected Publications Mullens W, Abrahams Z, Francis GS, Skouri HN, Starling RC, Young JB, Taylor DO, Tang WHW. Sodium nitroprusside for advanced low-output heart failure. J Am Coll Cardiol. 2008 Jul 15;52(3):200-207. Nfonsam V, Chand B, Rosenblatt S, Turner R, Luciano M. Laparoscopic management of distal ventriculoperitoneal shunt complications. Surg Endosc. 2008 Aug;22(8):1866-1870. O’Connor CM, Abraham WT, Albert NM, Clare R, Gattis Stough W, Gheorghiade M, Greenberg BH, Yancy CW, Young JB, Fonarow GC. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008 Oct;156(4):662-673. Pineyro MM, Makdissi A, Faiman C, Prayson RA, Reddy SK, Mayberg MC, Weil RJ, Hamrahian AH. Poor correlation of serum alpha-subunit concentration and magnetic resonance imaging following pituitary surgery in patients with nonfunctional pituitary macroadenomas. Endocr Pract. 2008 May;14(4):452-457. Pitt T, Brethauer S, Sherman V, Udomsawaengsup S, Metz M, Chikunguwo S, Chand B, Schauer P. Diagnostic laparoscopy for chronic abdominal pain after gastric bypass. Surg Obes Relat Dis. 2008 May-Jun;4(3):394-398. Rogers D. Final diagnosis: transient pseudohypoaldosteronism (TPH) caused by UTI without concordant obstructive uropathy. Clin Pediatr (Phila). 2008 May;47(4):405-408. Rossi JS, Flaherty JD, Fonarow GC, Nunez E, Gattis SW, Abraham WT, Albert NM, Greenberg BH, O’Connor CM, Yancy CW, Young JB, Davidson CJ, Gheorghiade M. Influence of coronary artery disease and coronary revascularization status on outcomes in patients with acute heart failure syndromes: A report from OPTIMIZEHF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure). Eur J Heart Fail. 2008 Dec;10(12):1215-1223. 44

Schocken DD, Benjamin EJ, Fonarow GC, Krumholz HM, Levy D, Mensah GA, Narula J, Shor ES, Young JB, Hong Y. Prevention of heart failure: a scientific statement from the American Heart Association Councils on Epidemiology and Prevention, Clinical Cardiology, Cardiovascular Nursing, and High Blood Pressure Research; Quality of Care and Outcomes Research Interdisciplinary Working Group; and Functional Genomics and Translational Biology Interdisciplinary Working Group. Circulation. 2008 May 13;117(19):2544-2565. Serhal D, Weil RJ, Hamrahian AH. Evaluation and management of pituitary incidentalomas. Cleve Clin J Med. 2008 Nov;75(11):793-801. Sharma J, Milas M, Berber E, Mazzaglia P, Siperstein A, Weber CJ. Value of intraoperative parathyroid hormone monitoring. Ann Surg Oncol. 2008 Feb;15(2):493-498. Shishehbor MH, Oliveira LPJ, Lauer MS, Sprecher DL, Wolski K, Cho L, Hoogwerf BJ, Hazen SL. Emerging cardiovascular risk factors that account for a significant portion of attributable mortality risk in chronic kidney disease. Am J Cardiol. 2008 Jun 15;101(12):1741-1746. Siperstein A, Berber E, Barbosa GF, Tsinberg M, Greene AB, Mitchell J, Milas M. Predicting the success of limited exploration for primary hyperparathyroidism using ultrasound, sestamibi, and intraoperative parathyroid hormone: analysis of 1158 cases. Ann Surg. 2008 Sep;248(3):420-428. Smith BR, Schauer P, Nguyen NT. Surgical approaches to the treatment of obesity: bariatric surgery. Endocrinol Metab Clin North Am. 2008 Dec;37(4):943-964. Stolar MW, Hoogwerf BJ, Gorshow SM, Boyle PJ, Wales DO. Managing type 2 diabetes: going beyond glycemic control. J Manag Care Pharm. 2008 Jun;14(5 Suppl B):s2-s19. Sui X, Gheorghiade M, Zannad F, Young JB, Ahmed A. A propensity matched study of the association of education and outcomes in chronic heart failure. Int J Cardiol. 2008 Sep 16;129(1):93-99.

Outcomes 2008

Tang WHW, Tong W, Jain A, Francis GS, Harris CM, Young JB. Evaluation and long-term prognosis of new-onset, transient, and persistent anemia in ambulatory patients with chronic heart failure. J Am Coll Cardiol. 2008 Feb 5;51(5):569-576. Thodiyil PA, Yenumula P, Rogula T, Gorecki P, Fahoum B, Gourash W, Ramanathan R, Mattar SG, Shinde D, Arena VC, Wise L, Schauer P. Selective nonoperative management of leaks after gastric bypass: lessons learned from 2675 consecutive patients. Ann Surg. 2008 Nov;248(5):782-792. Torre-Amione G, Anker SD, Bourge RC, Colucci WS, Greenberg BH, Hildebrandt P, Keren A, Motro M, Moye LA, Otterstad JE, Pratt CM, Ponikowski P, Rouleau JL, Sestier F, Winkelmann BR, Young JB. Results of a nonspecific immunomodulation therapy in chronic heart failure (ACCLAIM trial): a placebo-controlled randomised trial. Lancet. 2008 Jan 19;371(9608):228-236. Udomsawaengsup S, Brethauer S, Kroh M, Chand B. Percutaneous transesophageal gastrostomy (PTEG): a safe and effective technique for gastrointestinal decompression in malignant obstruction and massive ascites. Surg Endosc. 2008 Oct;22(10):2314-2318.

Young JB, Abraham WT, Albert NM, Gattis Stough W, Gheorghiade M, Greenberg BH, O’Connor CM, She L, Sun JL, Yancy CW, Fonarow GC. Relation of low hemoglobin and anemia to morbidity and mortality in patients hospitalized with heart failure (Insight from the OPTIMIZEHF registry). Am J Cardiol. 2008 Jan 15;101(2):223-230. Young JB, Abraham WT, Bourge RC, Konstam MA, Stevenson LW. Task force 8: Training in heart failure: endorsed by the Heart Failure Society of America. J Am Coll Cardiol. 2008 Jan 22;51(3):383-389. Young JB. A medical center is not a hospital. Cleve Clin J Med. 2008 Nov;75(11):762. Emergency Services Institute Glauser SR, Glauser J, Hatem SF. Diabetic muscle infarction: a rare complication of advanced diabetes mellitus. Emerg Radiol. 2008 Jan;15(1):61-65.

Williams SE, Cooper K, Richmond B, Schauer P. Perioperative management of bariatric surgery patients: focus on metabolic bone disease. Cleve Clin J Med. 2008 May;75(5):333-349. Yancy CW, Abraham WT, Albert NM, Clare R, Stough WG, Gheorghiade M, Greenberg BH, O’Connor CM, She L, Sun JL, Young JB, Fonarow GC. Quality of care of and outcomes for African Americans hospitalized with heart failure: findings from the OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) registry. J Am Coll Cardiol. 2008 Apr 29;51(17):1675-1684.

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Staff Listing Institute Chairman

Department of Endocrine Surgery

James Young, MD

Allan Siperstein, MD Chairman

Institute Quality Review Officer Christian Nasr, MD

Eren Berber, MD Quality Review Officer

Institute Patient Experience Officer Kresimira Milas, MD Institute Director of Clinical Research Amir Hamrahian, MD Bariatric and Metabolic Institute

Kresimira Milas, MD Jamie Mitchell, MD Department of Endocrinology, Diabetes and Metabolism Robert Zimmerman, MD Interim Chairman

Philip Schauer, MD Department Chairman, Advanced Laparoscopic and Bariatric Surgery

Laurence Kennedy, MD Chairman

Kathleen Ashton, PhD

Krupa Doshi, MD

Stacy Brethauer, MD Department Quality Review Officer

Marwan Hamaty, MD, MBA Amir Hamrahian, MD Betul Hatipoglu, MD

Bipan Chand, MD Karen Cooper, DO Leslie Heinberg, PhD Tomasz Rogula, MD, PhD Amy Windover, PhD

Sangeeta Kashyap, MD Adi E. Mehta, MD Christian Nasr, MD Leann Olansky, MD Mario Skugor, MD Mariam Stevens, MD Jennifer Wojtowicz, DO

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Outcomes 2008

Consultant Staff, Department of Endocrinology, Diabetes and Metabolism Charles Faiman, MD Angelo Licata, MD, PhD

Samuel Irefin, MD Tatyana Kopyeva, MD Brian Parker, MD R. Michael Ritchey, MD

S. Sethu K. Reddy, MD, MBA Pediatric Endocrinology Ajuah Davis, MD

Some physicians may practice in multiple locations. For a detailed list including staff photos, please visit clevelandclinic.org/staff.

Anzar Haider, MD Douglas Rogers, MD Scientist Manjula Gupta, PhD Endocrinology & Metabolism Institute Anesthesiology Karen Steckner, MD Section Head, Endocrine and Metabolic Surgery Anesthesiology Alexandru Gottlieb, MD Tatyana Kopyeva, MD Associate Section Head, Endocrine and Metabolic Surgery Anesthesiology Karen Steckner, MD Section Head, Bariatric Surgery Anesthesiology Maged Argalious, MD Alexandru Gottlieb, MD

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Contact Information General Patient Referral

Additional Contact Information

24/7 hospital transfers or physician consults

General Information

800.553.5056

216.444.2200

Endocrinology, Diabetes and Metabolism

Hospital Patient Information

Appointments/Referrals

216.444.2000

216.444.6568 or 800.223.2273, ext. 46568 Patient Appointments Bariatric Surgery Appointments/Referrals

216.444.2273 or 800.223.2273

216.445.2224 or 800.223.2273, ext. 52224 Medical Concierge Endocrine Surgery Appointments/Referrals

Complimentary assistance for out-of-state patients

216.444.5664 or 800.223.2273, ext. 45664

and families

On the Web at clevelandclinic.org/endo

800.223.2273, ext. 55580, or email [email protected] Global Patient Services/International Center Complimentary assistance for international patients and families 001.216.444.8184 or visit clevelandclinic.org/gps Cleveland Clinic in Florida 866.293.7866 For address corrections or changes, please call 800.890.2467

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Outcomes 2008

Institute Locations Main Campus 9500 Euclid Ave./A53 Cleveland, OH 44195 Huron Hospital 13951 Terrace Road East Cleveland, OH 44112 216.761.3300 Independence Family Health Center 5001 Rockside Road Crown Center II Independence, OH 44131 216.986.4000 Lorain Family Health and Surgery Center 5700 Cooper Foster Park Road Lorain, OH 44053 440.204.7400 Strongsville Family Health and Surgery Center 16761 SouthPark Center Strongsville, OH 44136 440.878.2500

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Cleveland Clinic Overview In 2007, Cleveland Clinic restructured its practice, bundling all clinical specialties into integrated practice units called institutes. An institute combines all the specialties surrounding a specific organ or disease system under a single roof. Each institute has a single leadership and focuses the energies of multiple professionals onto the patient. From access and communication to billing and point-of-care service, institutes will improve the patient experience at Cleveland Clinic. Cleveland Clinic’s main campus, with 50 buildings on 166 acres in Cleveland, Ohio, includes a 1,000-bed hospital, outpatient clinic, specialty institutes and supporting labs and facilities. Cleveland Clinic also operates 15 family health centers; eight community hospitals; one affiliate hospital; a rehabilitation hospital for children; a 150-bed hospital and clinic in Weston, Fla.; and health and wellness centers in Palm Beach, Fla., and Toronto, Canada. Cleveland Clinic Abu Dhabi (United Arab Emirates), a multispecialty care hospital and clinic, is scheduled to open in late 2012.

Now in its fifth year of existence, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University offers all students full tuition scholarships. The program will graduate its first 29 students as physician-scientists in 2009. Cleveland Clinic is consistently ranked among the top hospitals in America by U.S.News & World Report, and our heart and heart surgery program has been ranked No. 1 since 1995. For more information about Cleveland Clinic, please visit clevelandclinic.org

At the Cleveland Clinic Lerner Research Institute, hundreds of principal investigators, project scientists, research associates and postdoctoral fellows are involved in laboratory-based, translational and clinical research. Total annual research expenditures exceed $244 million from federal agencies, non-federal societies and associations, endowment funds and other sources. In an effort to bring research from bench to bedside, Cleveland Clinic physicians are involved in more than 2,400 clinical studies at any given time.

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Outcomes 2008

Services Resources for Physicians Cleveland Clinic Secure Online Services

Critical Care Transport: Anywhere in the world

Cleveland Clinic uses state-of-the-art digital information systems to offer secure online services such as online medical second opinions, medical record access, patient treatment progress for referring physicians (see below), and imaging interpretations by our subspecialty trained radiologists. For more information, please visit eclevelandclinic.org.

Cleveland Clinic’s critical care transport team serves critically ill and highly complex patients across the globe. The transport fleet comprises mobile ICU vehicles, helicopters and fixed-wing aircraft. The transport teams are staffed by physicians, critical care nurse practitioners, critical care nurses, paramedics and ancillary staff, and are customized to meet the needs of the patient. Critical care transport is available for children and adults.

MyChart This secure online tool connects patients to their own health information from the privacy of their home any time, day or night. Some features include renewing prescriptions, reviewing test results and viewing medications, all online. For the convenience of physicians and patients across the country, MyChart now offers a secure connection to GoogleTM Health. Google Health users can securely share personal health information with Cleveland Clinic, and record and share the details of their Cleveland Clinic treatment with the physicians and healthcare providers of their choice. To establish a MyChart account, visit clevelandclinic.org/mychart. DrConnect Whether you are referring from near or far, DrConnect streamlines communication from Cleveland Clinic physicians to your office. This complimentary online tool offers secure access to your patient’s treatment progress at Cleveland Clinic. With one-click convenience, you can track your patient’s care using the secure DrConnect website. To establish a DrConnect account, visit clevelandclinic.org/ drconnect or email [email protected]. MyConsult Online Medical Second Opinion This secure online service provides specialist consultations from our Cleveland Clinic experts and remote medical second opinions for more than 1,000 life-threatening and lifealtering diagnoses. MyConsult is particularly valuable for people who wish to avoid the time and expense of travel. For more information, visit clevelandclinic.org/myconsult, email [email protected] or call 800.223.2273, ext 43223.

Endocrinology & Metabolism Institute

To arrange a transfer for STEMI (ST elevated myocardial infarction), acute stroke, ICH (intracerebral hemorrhage), SAH (subarachnoid hemorrhage) or aortic syndromes, call 877.279.CODE (2633). For all other transfers, call 216.444.8302 or 800.553.5056.

CME Opportunities: Live and Online Cleveland Clinic’s Center for Continuing Education’s website, clevelandclinicmeded.com, offers hundreds of convenient, complimentary learning opportunities, from webcasts and podcasts to a host of medical publications including the Disease Management Project Online Medical Textbook, with more than 150 chapters. The site also offers a schedule of live CME courses, including international summits that focus on key areas of translational research. Many live CME courses are hosted in Cleveland, an economical option for business travel. Physicians can manage their CME credits by using the myCME Web Portal. Available 24/7, the site offers CME opportunities to medical professionals across the globe.

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9500 Euclid Avenue, Cleveland, OH, 44195 Cleveland Clinic is a nonprofit multispecialty academic medical center. Founded in 1921, it is dedicated to providing quality specialized care and includes an outpatient clinic, a hospital with more than 1,000 staffed beds, an education institute and a research institute. © The Cleveland Clinic Foundation 2009 Please visit us on the Web at clevelandclinic.org.

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