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Message from the Executive Director

Let me begin by wishing all of you a happy and prosperous 2016. I hope you had a chance to reflect on past accomplishments and enjoy time with your friends and family. At the DCRI we are excited about the upcoming year and the opportunities to improve the practice of medicine through innovative clinical research.

In this issue of the DCRI Newsletter, we demonstrate how our research covers multiple disciplines in medicine and surgery. In addition to highlighting some of our accomplishments at the 2015 American Heart Association Scientific Sessions, we describe analyses on breast cancer screening, clinical trials aimed at reducing drug-resistant pathogens in hospitals, and a new registry for idiopathic pulmonary fibrosis. In 2016 and the years ahead, we are committed to expanding our research capabilities across a variety of therapeutic areas.

Finally, I want to note that February is National Heart Month. To find out what the DCRI is doing to promote good heart health, please visit our new Heart Month website at heart.dcri.org.

Thank you for your continued collaboration and support of our mission. I look forward to working with you in 2016 to improve the care of patients around the world.

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

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

FEATURE

The DCRI in the News

DCRI faculty have been weighing in on the ideas and topics that are transforming the world of clinical research. In Applied Clinical Trials, Executive Director Eric Peterson, MD, MPH, discussed the promise of pragmatic clinical trials for improving clinical care. Director of Health Services

and Outcomes Research Adrian Hernandez, MD, MHS, penned an editorial about the benefits and challenges of using real-world data for clinical research in Clinical Leader. For the latest from the DCRI’s top thinkers, visit www.dcri.org/research.

NewsFeb/Mar2016

INSIDE THIS ISSUE: PAGE 1

MESSAGE FROM THE EXECUTIVE DIRECTOR

PAGE 1–3

FEATURE STORIES

PAGE 4

UPCOMING EVENTS

PAGES 5–7

SELECT PUBLICATIONS

The DCRI at AHA 2015

The DCRI was well-represented at the 2015 American Heart Association Scientific Sessions. If you missed us in Orlando, visit aha.dcri.org for news stories, interviews, photos, and more.

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News February/March 2016

Walk Hard

Traditionally, physicians have focused on five vital signs to determine a patient’s health: blood pressure, body temperature, breathing rate, heart rate, and pain. However, there is a sixth vital sign that can also provide important clues about your body’s wellbeing: walking speed.

The DCRI’s Janet Bettger, ScD, leads the 6th Vital Sign, a global research study powered by Apple’s ResearchKit. The study is designed to gather data on both walking speed and physical activity to create better markers of health and well-being. Bettger discussed the study’s aims and methods at a Duke Forward event in Denver last November. To learn more about the 6th Vital Sign, visit sixthvitalsign.dcri.org.

To Screen or Not to Screen

Women at average risk for breast cancer in the United States can benefit from mammographic screening, but the extent of that benefit—as well as that of the associated risks—remains unclear, according to a study by DCRI and Duke researchers.

The researchers conducted an analysis of studies on mammographic screening, clinical breast examination (CBE), and clinical outcomes in women considered to be at average risk for breast cancer (no genetic susceptibility, family history, previous breast neoplasia, or chest irradiation).

They found that for women of all ages, mammographic screening was associated with an approximately 20 percent reduction in

mortality. However, the study authors cautioned that many studies used different strategies to quantify the association between screening and patient outcomes, something doctors should consider when choosing a strategy for their patients.

The study was conducted as part of the American Cancer Society’s new guidelines development process.

Read more here.

Bug Hunt

Healthcare facilities continue to battle drug-resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA) that loiter on surfaces even after patient rooms have been cleaned and can cause new, sometimes-deadly infections.

But a study from DCRI and Duke researchers has found that using a combination of chemicals and UV light to clean patient rooms cut transmission of four major superbugs by a cumulative 30 percent among a specific group of patients -- those who stay overnight in a room where someone with a known positive culture or infection of a drug-resistant organism had previously been treated.

The randomized trial was conducted at nine hospitals in the Southeast from 2012 to 2014, including three Duke University Health System hospitals, a Veterans Affairs hospital, and

several smaller community healthcare centers. The trial studied how three cleaning methods affected the transmission of four drug-resistant pathogens: MRSA, vancomycin-resistant enterococci (VRE), C. difficile and Acinetobacter.

Read more here.

FEATURE

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News February/March 2016

FEATURE

Registry Results

The initial results of the first 49 people enrolled in the Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry, which shed light on characteristics of people with idiopathic pulmonary fibrosis (IPF) at the time of diagnosis, were released this fall.

The IPF-PRO Registry is an academic-industry alliance between Boehringer Ingelheim and the DCRI to better understand outcomes and disease progression for people with IPF, a rare and fatal lung disease.

“We are very excited to share this first look at real-world patients with IPF across 18 IPF academic centers in the United States,” said

the DCRI’s Michael Durheim, MD, the study’s lead author. “Over time, we look forward to helping the IPF community learn more about disease progression, quality of life and other outcomes that are important to patients. As this alliance continues, our objective is to advance the understanding of this devastating disease, through additional findings about diagnosis, treatment patterns and whether blood or genetic markers may impact patient outcomes.”

Read more here.

Model Behavior

Scientists at the DCRI and Duke Medicine are using transparent fish to watch in real time as Cryptococcal meningitis takes over the brain. The resulting images are worthy of a sci-fi movie teaser, but could be valuable in disrupting the real, crippling brain infection that kills more than 600,000 people worldwide each year.

Airborne cells of Cryptococcus make their way into our lungs practically every day — unwelcome guests, but of little consequence for those with healthy immune systems. But for those with compromised immunities, whether by HIV infection or cancer treatment, a resulting Cryptococcal meningitis infection can quickly become deadly.

To be able to target the infection with medications in the future, researchers need to know more about how the organism (technically a yeast), moves from the lungs into the blood

stream and through the blood-brain barrier. So they injected the organism into microscopic zebrafish larvae, which have clear bodies, and watched the infection take hold.

“What’s impressive is that, unlike in a mouse or rabbit, you can actually see the organism producing disease in the live animal,” said the DCRI’s John R. Perfect, MD, chief of the division of infectious diseases at Duke University School of Medicine. “Day-by-day, it’s growing and moving throughout the body. You can’t see this anywhere else.”

Read more here.

New Faculty Advisor

The DCRI Newsletter has a new faculty advisor. Dr. Adam DeVore is a new addition to the DCRI with expertise in outcomes research and clinical trials. He previously completed a residency in internal medicine at Brigham and Women’s Hospital and a fellowship in general cardiovascular medicine at Duke University. He is currently an Instructor in Medicine in the Division of Cardiology and is completing additional clinical training in advanced heart failure, specializing in the clinical care of patients requiring cardiac transplantation and left ventricular assist devices.

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News February/March 2016

CED Life Sciences Conference

March 1–2Raleigh, NC

American Society for Clinical Pharmacology and Therapeutics

March 8–12San Diego, CA

American College of Cardiology Annual Scientific Session and Expo

April 2–4Chicago, IL

American Academy of Neurology Annual Meeting

April 15–21Vancouver, BC

Pediatric Academic Societies Meeting

April 30–May 3Baltimore, MD

DIA Annual Meeting

June 26–30Philadelphia, PA

Association of Clinical Research Professionals Meeting and Expo

April 16–19Atlanta, GA

Visit the DCRI at Upcoming Conferences

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News February/March 2016

SELECTED PUBLICATIONS

Direct transfer from the referring hospitals to the catheterization laboratory to minimize reperfusion delays for primary percutaneous coronary intervention: Insights from the National Cardiovascular Data Registry

Anderson LL, French WJ, Peng SA, Vora AN, Henry TD, Roe MT, Kontos MC, Granger CB, Bates ER, Hellkamp A, Wang T. Circ Cardiovasc Interv. 2015 Sep;8(9):e002477.

Neonatal escherichia coli bloodstream infections: Clinical outcomes and impact of initial antibiotic therapy

Bergin SP, Thaden JT, Ericson JE, Cross H, Messina J, Clark RH, Fowler VG, Jr., Benjamin DK, Jr., Hornik CP, Smith P. Pediatr Infect Dis J. 2015 Sep;34(9):933-6.

Clinical MRSA isolates from skin and soft tissue infections show increased in vitro production of phenol soluble modulins

Berlon NR, Qi R, Sharma-Kuinkel BK, Joo HS, Park LP, George D, Thaden JT, Messina JA, Maskarinec SA, Mueller-Premru M, Athan E, Tattevin P, Pericas JM, Woods CW, Otto M, Fowler VG, Jr. J Infect. 2015 Oct;71(4):447-57.

Consistency of laboratory monitoring during initiation of mineralocorticoid receptor antagonist therapy in patients with heart failure

Cooper LB, Hammill BG, Peterson ED, Pitt B, Maciejewski ML, Curtis LH, Hernandez A. JAMA. 2015 Nov 10;314(18):1973-5.

Association between use of the 21-gene recurrence score assayand receipt of chemotherapyamong Medicare beneficiarieswith early-stage breast cancer,2005-2009

Dinan MA, Mi X, Reed SD, Lyman GH, Curtis L. JAMA Oncol. 2015 Nov 1;1(8):1098-109.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: Results from the ROADMAP study

Estep JD, Starling RC, Horstmanshof DA, Milano CA, Selzman CH, Shah KB, Loebe M, Moazami N, Long JW, Stehlik J, Kasirajan V, Haas DC, O’Connell JB, Boyle AJ, Farrar DJ, Rogers J. J Am Coll Cardiol. 2015 Oct 20;66(16):1747-61.

Serial high sensitivity cardiac troponin T measurement in acute heart failure: Insights from the RELAX-AHF study

Felker GM, Mentz RJ, Teerlink JR, Voors AA, Pang PS, Ponikowski P, Greenberg BH, Filippatos G, Davison BA, Cotter G, Prescott MF, Hua TA, Lopez-Pintado S, Severin T, Metra . Eur J Heart Fail. 2015 Dec;17(12):1262-70.

Development and validation of a single-item screener for self-reporting sexual problems in U.S. adults

Flynn KE, Lindau ST, Lin L, Reese JB, Jeffery DD, Carter J, Baron SR, Abramsohn E, Weinfurt K. J Gen Intern Med. 2015 Oct;30(10):1468-75.

Contemporary considerations for constructing a genetic risk score: An empirical approach

Goldstein BA, Yang L, Salfati E, Assimes T. Genet Epidemiol. 2015 Sep;39(6):439-45.

Association of patient enrollment in Medicare part D with outcomes after acute myocardial infarction

Goyal A, de Lemos JA, Peng SA, Thomas L, Amsterdam EA, Hockenberry JM, Peterson ED, Wang T. Circ Cardiovasc Qual Outcomes.2015 Dec;8(6):567-75.

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News February/March 2016

SELECTED PUBLICATIONS

Quality-of-life and economic outcomes of assessing fractional flow reserve with computed tomography angiography: PLATFORM

Hlatky MA, de BB, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas P. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-23.

Usability and acceptability of the QDACT-PC, an electronic point-of-care system for standardized quality monitoring in palliative care

Kamal AH, Kavalieratos D, Bull J, Stinson CS, Nicolla J, Abernethy A. J Pain Symptom Manage. 2015 Nov;50(5):615-21.

Psoriasis patients’ willingness to accept side-effect risks for improved treatment efficacy

Kauf TL, Yang JC, Kimball AB, Sundaram M, Bao Y, Okun M, Mulani P, Hauber AB, Johnson F. J Dermatolog Treat. 2015 Dec;26(6):507-13.

Metabolomic quantitative trait loci (mQTL) mapping implicates the ubiquitin proteasome system in cardiovascular disease pathogenesis

Kraus WE, Muoio DM, Stevens R, Craig D, Bain JR, Grass E, Haynes C, Kwee L, Qin X, Slentz DH, Krupp D, Muehlbauer M, Hauser ER, Gregory SG, Newgard CB, Shah S. PLoS Genet. 2015 Nov 5;11(11):e1005553.

Bridging unmet medical device ecosystem needs with strategically coordinated registries networks

Krucoff MW, Sedrakyan A, Normand S. JAMA. 2015 Oct 27;314(16):1691-2.

Hepatitis C virus treatment: Is It possible to cure all Hepatitis C virus patients?

Muir AJ, Naggie S. Clin Gastroenterol Hepatol. 2015 Nov;13(12):2166-72.

Benefits and harms of breast cancer screening: A systematic review

Myers ER, Moorman P, Gierisch JM, Havrilesky LJ, Grimm LJ, Ghate S, Davidson B, Mongtomery RC, Crowley MJ, McCrory DC, Kendrick A, Sanders G. JAMA. 2015 Oct 20;314(15):1615-34.

Biomarkers: Troponin testing-risk stratification to stratified medicine

Newby LK, Ohman E. Nat Rev Cardiol. 2015 Nov;12(11):625-6.

Clinical effectiveness of statin therapy after ischemic stroke: Primary results from the Statin Therapeutic Area of the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study

O’Brien EC, Greiner MA, Xian Y, Fonarow GC, Olson DM, Schwamm LH, Bhatt DL, Smith EE, Maisch L, Hannah D, Lindholm B, Peterson ED, Pencina MJ, Hernandez A. Circulation. 2015 Oct 13;132(15):1404-13.

The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation

O’Brien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson E. Eur Heart J. 2015 Dec 7;36(46):3258-64.

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SELECTED PUBLICATIONS

The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model: Part 1-Statistical methodology

O’Brien SM, Jacobs JP, Pasquali SK, Gaynor JW, Karamlou T, Welke KF, Filardo G, Han JM, Kim S, Shahian DM, Jacobs M. Ann Thorac Surg. 2015 Sep;100(3):1054-62.

Evaluating discrimination of risk prediction models: The C statistic

Pencina MJ, D’Agostino RB, Sr. JAMA. 2015 Sep 8;314(10):1063-4.

Use of implantable cardioverter-defibrillators among Medicare patients—Reply

Pokorney SD, Peterson ED, Wang T. JAMA. 2015 Nov 3;314(17):1874-5.

Measuring the quality of Barrett’s esophagus management with measures that are high quality

Rubenstein JH, Lieberman D, Fennerty B, Gellad Z. Gastroenterology. 2015 Nov;149(6):1298-301.

Management and outcomes in patients with moderate or severe functional mitral regurgitation and severe left ventricular dysfunction

Samad Z, Shaw LK, Phelan M, Ersboll M, Risum N, Al-Khalidi HR, Glower DD, Milano CA, Alexander JH, O’Connor CM, Wang A, Velazquez E. Eur Heart J. 2015 Oct 21;36(40):2733-41.

Specialty pharmaceuticals for hyperlipidemia--Impact on insurance premiums

Schulman KA, Balu S, Reed S. N Engl J Med. 2015 Oct 22;373(17):1591-3.

Gastrointestinal bleeding in patients with atrial fibrillation treated with rivaroxaban or warfarin: ROCKET AF trial

Sherwood MW, Nessel CC, Hellkamp AS, Mahaffey KW, Piccini JP, Suh EY, Becker RC, Singer DE, Halperin JL, Hankey GJ, Berkowitz SD, Fox KA, Patel M. J Am Coll Cardiol. 2015 Dec 1;66(21):2271-81.

Cardiovascular health knowledge and preventive practices in people living with HIV in Kenya

Temu TM, Kirui N, Wanjalla C, Ndungu AM, Kamano JH, Inui TS, Bloomfield G. BMC Infect Dis. 2015 Oct 14;15(1):421.

Strategies for treating chronic HCV infection in patients with cirrhosis: latest evidence and clinical outcomes

Wilder JM, Muir A. Ther Adv Chronic Dis. 2015 Nov;6(6):314-27.

Options to promote competitive generics markets in the United States

Wiske CP, Ogbechie OA, Schulman K. JAMA. 2015 Nov 24;314(20):2129-30.

Symptom burden of chronic lung disease compared with lung cancer at time of referral for palliative care consultation

Wysham NG, Cox CE, Wolf SP, Kamal A. Ann Am Thorac Soc. 2015 Sep;12(9):1294-301.

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News February/March 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 InstituteRoom 0311 Terrace Level

2400 Pratt StreetDurham, NC 27705

Reception Desk: 919.668.8700DCRI-info@dm.duke.edu

Learn more: Visit DCRI.org

Editor: Mark SlagleDesigner: Kim Best

Faculty Advisor: Adam DeVore