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NewsJune/July2016

INSIDE THIS ISSUE: PAGE 1

MESSAGE FROM THE EXECUTIVE DIRECTOR

PAGE 2–3

FEATURE STORIES

PAGE 4

UPCOMING EVENTS

PAGES 4–6

SELECT PUBLICATIONS

The DCRI at ACC 2016

DCRI faculty members and fellows presented some of their latest research at the 2016 American College of Cardiology’s Scientific Sessions. If you missed us in Chicago, visit acc.dcri.org for news stories, interviews, photos, and more.

Message from the Executive Director

As I write this newsletter, the somewhat unseasonably cool Durham spring has now given way to the heat of a Southern summer. This change in the weather also marks other changes. Children finish school and are off to camps or other adventures; families take vacation time; and even our fellows at the DCRI turn over, with some leaving for new jobs while others take their place. For me, summer brings my son and daughter home from college to spend a bit of precious time with us before going off to summer internships. Summer is also a time that I enjoy my annual pilgrim-age to Connecticut to enjoy some downtime at the lake. I hope each of you have similar plans and opportunities to get away, reflect, and recharge.

This issue of the DCRI Newsletter highlights how the DCRI is leading the way in opening access to data and promoting science. Recently, we partnered with SAS Institute to allow researchers from around the globe to access data from the Duke Databank for Cardiovascular Disease (DDCD). The DDCE was the brainchild of Dr. Eugene Stead, Duke’s first chair of the Department of Medicine in the 1960s. It was his vision that doctors could routinely collect data and follow-up information on heart patients treated at Duke to learn how to treat future patients better. This process of data collection and analysis spawned hundreds of papers and shaped a generation of physicians, biostatisticians, and operations personal devoted to evidence-based medicine.

Today, the DDCD is the oldest and largest compilation of detailed clinical data on heart patients with comprehensive, long-term records on more than 200,000 people. Opening access to this data reflects our commitment to open science and is part of the DCRI’s mission to develop and share knowledge that improves the care of patients around the world. We hope this example will encourage other academic organizations to open access to their data in the spirit of improving patient care.

Thank you for your collaboration and ongoing support of the DCRI. I look forward to working with you in the months and years ahead.

Eric D. Peterson, MD, MPH, FAHA, FACC

Executive Director Duke Clinical Research InstituteProfessor of Medicine, CardiologyFred Cobb Distinguished Professor of Medicine

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News June/July 2016

FEATURE

Data Detectives Early use of platforms designed to provide access to individual patient data and developed to increase transparency of clinical trial data has been limited, according to a study by DCRI researchers. Ann Marie Navar, MD, PhD, and her colleagues explored three open access platforms – ClinicalStudyDataRequest.com, the Yale University Open Data Access Project (YODA), and the Supporting Open Access for Researchers (SOAR) initiative – to determine how many clinical trials were publicly available to investigators and how these open trial data were being used. Although more than 3,000 trials are currently available, only 15.5 percent of these had been requested.

Open Book A new collaboration will give more researchers access to the larg-est and oldest cardiovascular database in the world. The DCRI and analytics leader SAS will provide researchers worldwide with data management and analytics tools to explore 45 years of cardiovas-cular patient data collected by the Duke University Health System. The data set is part of the Duke Databank for Cardiovascular Disease (DDCD). The databank includes de-identified records for patients treated at Duke between 1969 and 2013, and data from more than 100,000 procedures on more than 50,000 unique patients.

“While many support open science in theory, to date, few aca-demics have been willing to actually share their own data. This is among the first examples where academic leaders are actually opening their clinical research data to others. This initiative

“We found that researchers are accessing data mainly to conduct secondary analyses, as opposed to validation studies of the initial trial results,” Navar said. “While the science currently being con-ducted with these data reflects the wealth of information in the databases, it may not be meeting the goals of proponents of open access.” Read more here.

provides a prototype for the field and is an incredibly important step toward greater data access for researchers everywhere,” said Michael Pencina, PhD, director of biostatistics at the DCRI. Read more here.

Ann Marie Navar, MD, PhD DCRI Research Fellow Cardiology

Michael Pencina, PhD Director of Biostatistics

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News June/July 2016

FEATURE

Growing Epidemic The alarming increase in U.S. childhood obesity rates that began nearly 30 years ago continues unabated, with the biggest increases in severe obesity, according to a study led by a DCRI researcher.

“Despite some other recent reports, we found no indication of a decline in obesity prevalence in the United States in any group of children aged 2 through 19,” said lead author Asheley Skinner, PhD. “This is particularly true with severe obesity, which remains high, especially among adolescents.”

Skinner, along with colleagues at the University of North Carolina at Chapel Hill and Wake Forest University, analyzed data from a large, ongoing compilation of health information that has spanned decades. They found that for 2013-2014, 33.4 percent of children

Practice Makes Perfect A new study conducted by DCRI researchers suggests that patients who need to have their thyroid gland removed should seek surgeons who perform 25 or more thyroidectomies a year for the least risk of complications.

Thyroidectomy is one of the most common operations performed in the United States, often due to cancer, over-activity, or enlarge-ment of the gland, which is located at the base of the throat and produces hormones that regulate metabolism. But only about half (51 percent) of surgeons who perform thyroidectomy do so just once a year, according to the study published in the Annals of Surgery.

“This is a very technical operation, and patients should feel empowered to ask their surgeons how many procedures they do each year, on average,” said the DCRI’s Julie A. Sosa, MD, senior

between the ages of 2 through 19 were overweight. Among those, 17.4 percent had obesity, which includes a range from the lower end of the designation criteria to the higher end. “An estimated 4.5 million children and adolescents have severe obesity and they will require new and intensive efforts to steer them toward a healthier course,” Skinner said. “Studies have repeatedly shown that obesity in childhood is associated with worse health and shortened lifespans as adults.” Read more here.

author and chief of endocrine surgery at Duke. “Surgeons have an ethical responsibility to report their case numbers. While this is not a guarantee of a positive outcome, choosing a more experienced surgeon certainly can improve the odds that the patient will do well.” Read more here.

Asheley Skinner, PhD Instructor, Department of Medicine

Julie A. Sosa, MD Chief of Endocrine Surgery

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News June/July 2016

Visit the DCRI at Upcoming Conferences

Drug Information Association 2016 Annual Meeting

June 26-30

Philadelphia, PA

SELECTED PUBLICATIONS

Gait speed predicts 30-day mortality after transcatheter aortic valve replacement: Results from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

Alfredsson J, Stebbins A, Brennan JM, Matsouaka R, Afilalo J, Peterson ED, Vemulapalli S, Rumsfeld JS, Shahian D, Mack MJ, Alexander K. Circulation. 2016 Apr 5;133(14):1351-9.

Training and capacity building in LMIC for research in heart and lung diseases: The NHLBI-UnitedHealth Global Health Centers of Excellence Program

Bloomfield GS, Xavier D, Belis D, Alam D, Davis P, Dorairaj P, Ghannem H, Gilman RH, Kamath D, Kimaiyo S, Levitt N, Martinez H, Mejicano G, Miranda JJ, Koehlmoos TP, Rabadan-Diehl C, Ramirez-Zea M, Rubinstein A, Sacksteder KA, Steyn K, Tandon N, Vedanthan. Glob Heart. 2016 Mar;11(1):17-25.

Practical telemedicine for veterans with persistently poor diabetes control: A randomized pilot trial

Crowley MJ, Edelman D, McAndrew AT, Kistler S, Danus S, Webb JA, Zanga J, Sanders LL, Coffman CJ, Jackson GL, Bosworth H. Telemed J E Health. 2016 May;22(5):376-84.

Polymorphisms in HLA class II genes are associated with susceptibility to staphylococcus aureus infection in a white population

DeLorenze GN, Nelson CL, Scott WK, Allen AS, Ray GT, Tsai AL, Quesenberry CP, Jr., Fowler VG, Jr. J Infect Dis. 2016 Mar 1;213(5):816-23.

Has public reporting of hospital readmission rates affected patient outcomes?: Analysis of Medicare claims data

DeVore AD, Hammill BG, Hardy NC, Eapen ZJ, Peterson ED, Hernandez A. J Am Coll Cardiol. 2016 Mar 1;67(8):963-72.

Slow gait speed and risk of mortality or hospital readmission after myocardial infarction in the translational research investigating underlying disparities in recovery from acute myocardial infarction: Patients’ Health Status Registry

Dodson JA, Arnold SV, Gosch KL, Gill TM, Spertus JA, Krumholz HM, Rich MW, Chaudhry SI, Forman DE, Masoudi FA, Alexander K. J Am Geriatr Soc. 2016 Mar;64(3):596-601.

Racial/ethnic differences in atrial fibrillation symptoms, treatment patterns, and outcomes: Insights from Outcomes Registry for Better Informed Treatment for Atrial Fibrillation Registry

Golwala H, Jackson LR, Simon DN, Piccini JP, Gersh B, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas L, Fonarow GC, Peterson ED, Thomas K. Am Heart J. 2016 Apr;174:29-36.

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News June/July 2016

SELECTED PUBLICATIONS

Enteral feeding with human milk decreases time to discharge in infants following gastroschisis repair

Gulack BC, Laughon MM, Clark RH, Burgess T, Robinson S, Muhammad A, Zhang A, Davis A, Morton R, Chu VH, Arnold CJ, Hornik CP, Smith P. J Pediatr. 2016 Mar;170:85-9.

Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial

Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Ohman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez A. Am Heart J. 2016 Apr;174:103-10.

Insulin, hyperglycemia, and severe retinopathy of prematurity in extremely low-birth-weight infants

Lee JH, Hornik CP, Testoni D, Laughon MM, Cotten CM, Maldonado RS, Belcastro MR, Clark RH, Smith P. Am J Perinatol. 2016 Mar;33(4):393-400.

Spontaneous MI after non-ST-segment elevation acute coronary syndrome managed without revascularization: The TRILOGY ACS trial

Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe M. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97.

Assessment of device-related thrombus and associated clinical outcomes with the WATCHMAN left atrial appendage closure device for embolic protection in patients with atrial fibrillation (from the PROTECT-AF Trial

Main ML, Fan D, Reddy VY, Holmes DR, Gordon NT, Coggins TR, House JA, Liao L, Rabineau D, Latus GG, Huber KC, Sievert H, Wright RF, Doshi SK, Douglas P. Am J Cardiol. 2016 Apr 1;117(7):1127-34.

Quality-of-life outcomes with anatomic versus functional diagnostic testing strategies in symptomatic patients with suspected coronary artery disease: Results from the PROMISE randomized trial

Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas P. Circulation. 2016 May 24;133(21):1995-2007.

Good clinical practice guidance and pragmatic clinical trials: Balancing the best of both worlds

Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O’Brien EC, Ibarra JC, Curtis LH, Peterson E. Circulation. 2016 Mar 1;133(9):872-80.

Patient preferences for features of health care delivery systems: A Discrete choice experiment

Muhlbacher AC, Bethge S, Reed SD, Schulman K. Health Serv Res. 2016 Apr;51(2):704-27.

Use of open access platforms for clinical trial data

Navar AM, Pencina MJ, Rymer JA, Louzao DM, Peterson E. JAMA. 2016 Mar 22-29;315(12):1283-4.

A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study

Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson C. Am Heart J. 2016 Apr;174:120-8.

Increased in vitro phenol-soluble modulin production is associated with soft tissue infection source in clinical isolates of methicillin-susceptible Staphylococcus aureus

Qi R, Joo HS, Sharma-Kuinkel B, Berlon NR, Park L, Fu CL, Messina JA, Thaden JT, Yan Q, Ruffin F, Maskarinec S, Warren B, Chu VH, Fortes CQ, Giannitsioti E, Durante-Mangoni E, Kanafani ZA, Otto M, Fowler VG, Jr. J Infect. 2016 Mar;72(3):302-8.

Neighborhood clustering of non-communicable diseases: Results from a community-based study in Northern Tanzania

Stanifer JW, Egger JR, Turner EL, Thielman N, Patel U. BMC Public Health. 2016 Mar 5;16(1):226.

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News June/July 2016

SELECTED PUBLICATIONS

Potential cost-effectiveness of early identification of hospital-acquired infection in critically ill patients

Tsalik EL, Li Y, Hudson LL, Chu VH, Himmel T, Limkakeng AT, Katz JN, Glickman SW, McClain MT, Welty-Wolf KE, Fowler VG, Ginsburg GS, Woods CW, Reed S. Ann Am Thorac Soc. 2016 Mar;13(3):401-13.

Coronary-artery bypass surgery in patients with ischemic cardiomyopathy

Velazquez EJ, Lee KL, Jones RH, Al-Khalidi HR, Hill JA, Panza JA, Michler RE, Bonow RO, Doenst T, Petrie MC, Oh JK, She L, Moore VL, svigne-Nickens P, Sopko G, Rouleau J. N Engl J Med. 2016 Apr 21;374(16):1511-20.

Pharmacometabolomics meets genetics: A “natural” clinical trial of statin effects

Voora D, Shah S. J Am Coll Cardiol. 2016 Mar 15;67(10):1211-3.

Temporal trends in the risk profile of patients undergoing outpatient percutaneous coronary intervention: A report from the National Cardiovascular Data Registry’s CathPCI Registry

Vora AN, Dai D, Gurm H, Amin AP, Messenger JC, Mahmud E, Mauri L, Wang TY, Roe MT, Curtis J, Patel MR, Dauerman HL, Peterson ED, Rao S. Circ Cardiovasc Interv. 2016 Mar;9(3):e003070.

Validation of BARC bleeding criteria in patients with acute coronary syndromes: The TRACER trial

Vranckx P, White HD, Huang Z, Mahaffey KW, Armstrong PW, Van de WF, Moliterno DJ, Wallentin L, Held C, Aylward PE, Cornel JH, Bode C, Huber K, Nicolau JC, Ruzyllo W, Harrington RA, Tricoci. J Am Coll Cardiol. 2016 May 10;67(18):2135-44.

Women in interventional cardiology: Update in percutaneous coronary intervention practice patterns and outcomes of female operators from the National Cardiovascular Data Registry

Wang TY, Grines C, Ortega R, Dai D, Jacobs AK, Skelding KA, Mauri L, Mehran. Catheter Cardiovasc Interv. 2016 Mar;87(4):663-8.

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News June/July 2016

Publication Information:This newsletter is published periodically as a service to the DCRI’s investigational sites and collaborators. The purpose is to provide information of interest to individuals involved in clinical trials and outcomes

studies managed by the Duke Clinical Research Institute.

Duke Clinical Research Institute2400 Pratt Street

Durham, NC 27705919.668.8700

dcri.news@duke.edu

Learn more: Visit DCRI.org

Editor: Mark SlagleDesigner: Wally Lamb

Faculty Advisor: Adam DeVore