Quick Hits Newsletter – Fall 2017
Recognition of the unique attributes of childhood that merit a special research focus is relatively new to the field of child health research. The Pediatric Collaborative Research Group (CRG) is dedicated to supporting the development of multi-network research projects for children and adolescents while advancing the sustainability of PCORnet as a research consortium.
The Pediatric CRG includes five Research Interest Groups (RIGs): Autism, Cerebral Palsy, Epilepsy, Hypertension, and Sickle Cell Disease. Starting September 15, each RIG will host an activity involving the prioritization of condition-specific research questions. The activity will be conducted through an online platform that allows researchers and clinicians to rank and edit the list of research questions to set an agenda for future research. If you are interested in participating, please email email@example.com.
During the past year, OneFlorida has partnered with Accelerating Data Value Across a National Community Health Center Network (ADVANCE), a CDRN based in Portland, Oregon, on a PCORI-funded project called “The Impact of Patient Complexity on Healthcare Utilization.” Health Choice Network, a participating member of both ADVANCE and OneFlorida, also collaborated on this project. In this 12-month study, ADVANCE, the coordinating site, and OneFlorida collaborated with patient, provider and health-system stakeholders to determine whether quality outcomes could be better explained when accounting for patients’ social determinants of health (SDH). Research suggests that SDH – the economic, social, and environmental characteristics of our lives— may contribute as much or even more to health outcomes than medical care. However, care quality metrics typically emphasize disease-specific clinical outcomes and do not include SDH measures.
Stakeholders selected clinical and social measures to analyze relationships between clinical complexity (using the Charlson Comorbidity Index), social complexity (using community-level SDH variables), and quality of care. As expected, patients in our sample live in more socially vulnerable communities than the average U.S. population, and accounting for social and clinical complexity explained more of the variation in clinic-level care quality – such as diabetes control or emergency department utilization – than did accounting for clinical complexity alone. Although the effect of SHD on quality of care was lower than stakeholders expected, even the slight decrease that occurred when social complexity was factored in resulted in improved performance metrics.
Stakeholders recommended practice and policy approaches to effectively integrate social complexity into quality assessment models. Detailed study findings are in preparation for peer-reviewed publication and presentation at local and national meetings. A toolkit that other data networks can use to replicate these analyses and assess their own populations will be available shortly.
A team of University of Florida (UF) researchers and staff will present a new citizen-scientist teaching curriculum at the Association for Educational Communications and Technology’s (AECT’s) annual convention in November 2017. The AECT is a professional association of thousands of educators and others whose activities focus on improving instruction through technology. This year’s convention, “Leading Learning for Change,” takes place in Jacksonville, Fla. from Nov. 6-11.
The UF team developed the curriculum for the UF Clinical and Translational Science Institute (UF CTSI) Citizen Scientist Program, in which citizens from the community serve as collaborators on clinical research teams at UF. The 11 citizen scientists in the program, administered jointly by the UF CTSI and the OneFlorida Clinical Research Consortium, work closely with UF researchers, offering lay perspectives on everything from proposal reviews to patient recruitment strategies, and in other areas where stakeholder engagement may be needed. In 2016, a separate teen citizen scientist group formed to provide advice and feedback on pediatric-oriented research studies.
Throughout history, ordinary citizens with little or no formal training in the sciences have played important roles in fields such as archaeology, astronomy and natural history. Thomas Edison was a citizen scientist, as was Gregor Mendel, the 19th Century priest whose experiments on heredity in pea plants helped establish the field of genetics. However, the idea of engaging stakeholders from the community to help inform clinical research is new — so new, in fact, that when the UF CTSI Citizen Scientist Program got started, instructional materials for program participants were scarce.
To address the need for citizen-scientist instructional materials at UF and elsewhere, the UF team developed an online, self-paced curriculum to train new program participants using a web-based platform. The curriculum contains modules on research ethics, sponsored research, clinical and translational science, stakeholder engagement, cultural diversity in research, and biomedical informatics. Each module contains videos presented by subject matter experts, case studies, footage of citizen scientists in action, and resources to aid learning. The curriculum offers three levels of citizen scientist certification based on the levels of participant engagement: minimal, moderate and sustained.
The curriculum can be easily customized to suit the needs of citizen scientist groups at other institutions. In keeping with the institution goals of involving community stakeholders in research and supporting socially responsible practices in clinical research, the training materials will be available as an open educational resource (OER), which means they can be accessed by anyone for free. To access the curriculum, visit http://ctsi-citizen-scientist-program.sites.medinfo.ufl.edu.
UF team members involved in developing the citizen scientist curriculum include Janet Brishke, MPH, research coordinator III at the OneFlorida Clinical Research Consortium; Christy Evans, a UF citizen scientist; Albert Dieter Ritzhaupt, Ph.D., PMP, associate professor of educational technology in UF’s College of Education; Eileen Handberg, Ph.D., ARNP, associate professor in the Department of Cardiology; Natercia Valle, a graduate assistant in curriculum development and instructional design in UF’s College of Education; Betsy Shenkman, Ph.D., chair of the Department of Health Outcomes & Policy, director of UF’s Institute for Child Health Policy, co-chair of the UF CTSI and director of the OneFlorida Clinical Research Consortium; and David Nelson, M.D., director of the UF CTSI, assistant vice president for research and associate dean of the College of Medicine.
The UF team also was invited to participate in the AECT’s premier “Formative Design in Learning” symposium to be held in Jacksonville on July 22-23. The symposium, held in conjunction with the AECT’s Summer Leadership Meetings, brings together participants to share in a peer-review process expected to help them with manuscript submissions to the Journal of Formative Design in Learning. The UF team is preparing a journal article about the curriculum’s creation and design process for publication in the peer-reviewed journal, which publishes papers on research-based design and development in the field of teaching and learning.
The UF CTSI Citizen Scientist Program is one of many ways in which UF researchers have begun moving toward a model of patient-centered research. By engaging stakeholders throughout the research process, scientists hope to ensure that clinical trials address questions that are important to the end-users, and that patients enrolled in the studies reflect the diversity of real communities. To learn more about the UF CTSI Citizen Scientist Program, visit the UF CTSI website (https://www.ctsi.ufl.edu).
Two OneFlorida Minority Education Program (MEP) mentees—Danyell Wilson, Ph.D., and Rima Tawk, Ph.D.—attended the American Association for Cancer Research’s 2017 annual meeting in Washington, D.C. last spring. Wilson also received a Minority and Minority-Serving Institution Faculty Scholar in Cancer Research Award at the meeting.
Wilson, an associate professor in the department of natural sciences at Bethune-Cookman University in Daytona Beach, was one of 17 recipients of the 2017 Minority and Minority-Serving Institution Faculty Scholar in Cancer Research Awards. The awards are given to full time graduate students, medical students, residents or clinical or postdoctoral fellows belonging to minority groups that have been defined by the National Cancer Institute as being traditionally underrepresented in cancer and biomedical research, including African-Americans, Alaskan Natives, Hispanics, Native Americans and Native Pacific Islanders.
Wilson received the award for her abstract, “Gender and Racial Disparities in Incidence Trends of Tobacco-Related Cancers from 2010 to 2013.” Wilson’s study identified cancer prevention resources, including smoking cessation programs, community outreach organizations that promote cancer prevention and education, and local events including health fairs and festivals, workshops and campaigns in the 29-county catchment area around the University of Florida Cancer Center in Gainesville. Wilson, who has ten years of laboratory experience in the fields of biochemistry, nanotechnology, polymer science and electrophysiology, plans to analyze organizations and events (O&E) in the catchment area that occurred between Jan. 2010-Dec. 2016 and look for correlations in O&E interventions and cancer incidence and mortality hot spots.
Tawk is an assistant professor of health policy and management at Florida A&M University’s Institute of Public Health in Tallahassee. Her research focuses on health disparities in cancer outcomes, mental health and quality of care. Tawk received her doctorate in health policy and administration from the University of Illinois at Chicago (UIC) in 2010. Her dissertation work converged around understanding why patients fail to comply with treatment and leave the hospital against medical advice. She holds a master’s degree in health policy and administration from the University of Illinois at Chicago and a master’s degree in biology from the American University of Beirut, Lebanon. In 2012, she completed two years of post-doctoral training at the UIC Center for Pharmacoeconomic research /Takeda Pharmaceuticals International. The focus of her fellowship experience has been on evaluating economic, humanistic and clinical outcomes of drug therapy in several therapeutic areas.
Both Wilson and Tawk are working with mentor Yi Guo, Ph.D., assistant professor in the Department of Health Outcomes & Policy in the College of Medicine at UF, on a project related to characterization of the UF Health Cancer Center’s catchment area.
The OneFlorida MEP program provides a mentored research experience wherein minority junior faculty members receive hands-on research experience by partnering with faculty members affiliated with the OneFlorida Clinical Research Consortium.
Jiang Bian, Ph.D., and Ravi Bhosale represented the OneFlorida Clinical Research Consortium at the AMIA 2017 Joint Summits on Translational Science held in San Francisco in March.
Bian, assistant professor in the University of Florida’s Department of Health Outcomes & Policy, organized the “Implementing Record Linkage Solutions in the PCORnet Clinical Data Research Networks” panel, which featured representatives from each of PCORnet’s Clinical Data Research Networks. Together, panelists shared and described their experiences with implementing record linkage solutions within their respective CDRNs and discussed lessons learned along the way.
Bhosale, a citizen scientist with the UF Clinical and Translational Science Institute and the OneFlorida Core Data Trust Infrastructure Workgroup, co-authored a presented paper, “Strategic Assessment and Planning for the PCORnet Common Data Model,” which proposes additional data elements for inclusion in the Common Data Model (CDM).
“The Joint Summits provide a rare opportunity for informatics professionals across different disciplines to convene and discuss industry developments and challenges,” said Bian. “We look forward to exploring ways that the OneFlorida informatics team can leverage some of the ideas and new developments discussed at the meeting.”
The Obesity Research Alliance (ORA), sponsored by the OneFlorida Clinical Research Consortium, wrapped up a successful first year for its annual seminar series, bringing to campus a variety of renowned obesity researchers to discuss findings, exchange ideas, and keep UF’s diverse, multidisciplinary community of obesity researchers informed about current topics and trends.
“We were very pleased with the outstanding caliber of speakers and the broad range of topics we were able to bring to UF during the first year of this seminar series,” said Michelle Cardel, Ph.D., an assistant professor in the Department of Health Outcomes and Policy and one of the founding members of the alliance. “We had an excellent turnout of faculty, students and staff from all over campus, and the greatest benefit has been the increase in collaborations of UF obesity scientists across campus and with the seminar speakers, resulting in increased grants and scientific publications submitted together.”
Established in 2016, UF’s ORA serves as an interdisciplinary umbrella to foster a multidisciplinary approach to basic, clinical, and translational obesity research across disciplines on UF’s campus. Other founding members are Janet Silverstein, M.D., professor and chief of pediatric endocrinology in the College of Medicine’s Department of Pediatrics, and David Janicke, Ph.D., professor in the Department of Clinical and Health Psychology in the College of Public Health and Health Professions.
The seminar series was sponsored by the Department of Health Outcomes and Policy, UF’s Institute for Child Health Policy, the OneFlorida Clinical Research Consortium, the UF Clinical and Translational Science Institute and the UF Diabetes Institute.
Speakers for the 2016-17 ORA seminar series included David Allison, Ph.D., endowed professor and director of the NIH-funded Nutrition and Obesity Research Center at the University of Alabama at Birmingham; Michael Goran, Ph.D., director of the University of Southern California’s (USC’s) Diabetes and Obesity Research Institute; Barbara Hansen, Ph.D., director of the Obesity, Diabetes and Aging Research Center at the University of South Florida in Tampa; Corby Martin, Ph.D., director of the Ingestive Behavior Laboratory at Louisiana State University’s Pennington Biomedical Research Center; and Vasiliki Michopoulos, Ph.D., assistant professor in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine in Atlanta. Links to the entire series of seminars are available below.
Obesity is a disease that can impact an individual’s physical, social, emotional, and financial health. Thus, there is a great deal of research on UF’s campus in a variety of disciplines. Cardel said one of the alliance’s main objectives is to facilitate collaboration and sharing among obesity researchers across the UF campus, bringing together various disciplines and diverse experiences to enrich and expand our strategies for combatting obesity. Additionally, the ORA seeks to provide mentoring and opportunities to early-career investigators, including a trainee luncheon with all speakers.
The ORA currently has 56 members consisting of faculty, staff and trainees in several colleges, institutes, centers and departments, including IFAS and the Colleges of Medicine; Nursing; Public Health and Health Professions; Health and Human Performance; and the Departments of Health Outcomes and Policy; Clinical and Health Psychology; Endocrinology; Food Science and Human Nutrition; Pediatrics; Aging and Geriatrics; Epidemiology; Behavioral Science and Community Health; Food and Resource Economics; Health Services Research, Management and Policy; Gastroenterology; and Health Education and Behavior.
Plans for the 2017-18 series of ORA seminars are already underway and include the following speakers:
- Carmen Isasi, M.D., Ph.D., at Albert Einstein College of Medicine in New York (Tuesday, October 24)
- Meghan Butryn, Ph.D., associate professor in the Department of Psychology at Drexel University in Philadelphia (Tuesday, December 5)
- Anthony Comuzzie, Ph.D., FTOS, Executive Director of The Obesity Society (Tuesday, January 23)
For more information about upcoming speakers or to learn more about the UF Obesity Research Alliance, contact Darci Miller at firstname.lastname@example.org. Anyone with an interest in obesity research is welcome to join.
UF ORA 2016-17 Seminar Series
Click on the links below to view each speaker’s presentation. PLEASE NOTE: For optimal streaming, please use the most recent version of Firefox, Internet Explorer, or Safari web browsers. The current hosting system is not compatible with Google Chrome.
David Allison, Ph.D., endowed professor and director of the NIH-funded Nutrition and Obesity Research Center at the University of Alabama, Birmingham: “Obesity, Energetics, & Longevity: Social, Experimental, Evolutionary, & Epidemiologic Perspectives” (May 16, 2017) https://mediasite.video.ufl.edu/Mediasite/Play/5170563596b54430b732b433495b82111d
Michael Goran, Ph.D., director of the University of Southern California’s (USC’s) Diabetes and Obesity Research Institute: “Secondhand Sugars: Role of Dietary Sugars in the Early Development of Obesity and Metabolic Risk” (March 7, 2017) https://mediasite.video.ufl.edu/Mediasite/Play/7bfcc6a3c3b84a88b59304ee611d79271d
Barbara Hansen, Ph.D., director of the Obesity, Diabetes and Aging Research Center at the University of South Florida, Tampa: “A Longitudinal Study of Obesity & Type II Diabetes: Lessons Regarding the New Dietary & Obesity Guidelines” (September 20, 2016) https://mediasite.video.ufl.edu/Mediasite/Play/b7d64c08cbe14c31b20db32fef7452df1d
Corby Martin, Ph.D., director of the Ingestive Behavior Laboratory at LSU’s Pennington Biomedical Research Center: “Attempts to Address the Fundamental Flaw in Obesity Research with New (and Old) Technology” (December 6, 2016) https://mediasite.video.ufl.edu/Mediasite/Play/d8763b235958428f81c3f71760553d821d
Vasiliki Michopoulos, Ph.D., assistant professor in the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine: “Effects of Obesogenic Dietary Environment & Adverse Psychosocial Experience on Food Intake & the Brain in Non-Human Primates” (June 20, 2017) https://mediasite.video.ufl.edu/Mediasite/Play/09fd6a6203134337bed630c835ac3a301d
OneFlorida Child Health Alliance Leader Receives Local Hero Award from American Academy of Pediatrics
Lindsay Thompson, M.D., M.S., received the American Academy of Pediatrics’ (AAP’s) 2017 Local Hero Award, which recognizes recipients for their outstanding community action and advocacy for children in local communities. Thompson, associate professor of pediatrics and health policy at UF and assistant director of clinical research at UF’s Institute for Child Health Policy (ICHP), is one of only two pediatricians in the United States and Canada to receive the award.
The AAP is the professional organization representing some 64,000 pediatricians and child health specialists nationwide. The group selects award recipients from its members via a competitive nominations process that includes letters of support from individuals who are familiar with the nominees’ work in community pediatrics.
Nominator Erik W. Black, Ph.D., associate professor of pediatrics and education in the Division of General Pediatrics at UF, cited Thompson’s capacity as continuity clinic preceptor and faculty leader at UF, her role as assistant director of research at ICHP, and her work with the University of Florida Early Learning Coalition as examples of her exceptional community involvement. Thompson provides guidance and expertise to the Early Learning Coalition as the group considers statewide initiatives related to early childhood education in Florida.
“She is a practitioner who understands and role-models the value of community resources, interprofessional approaches to problem-solving and partnership while balancing a dynamic, diverse work life for future pediatricians, researchers and child advocates,” Black wrote.
Gainesville Attorney Daniel Glassman, whose children were patients of Thompson’s for 11 years, commended Thompson for her dedication to improving children’s health through community involvement, engagement and advocacy.
“Whether it is helping with school-age children exercising before school, helping fund-raise for cancer and Duchenne Muscular Dystrophy, or providing examinations for school sports, I have never seen any physician give so much of herself to her community,” Glassman wrote in a letter nominating her for the award.
Nominators praised Thompson for being an outstanding pediatrician, as well.
“My wife, who was the mother of my two children, passed away in 2008 from brain cancer,” Glassman wrote. “From the moment of diagnosis, Dr. Thompson made sure that my children, aged 5 and 8, not only received necessary well checks, but also ensured that their emotional and psychological treatment was constantly evaluated and made a focal point of their care. Based on large part on the kindness and care that Dr. Thompson provided, ten years later, my daughter is graduating near the top of her class and just received admission to the University of Florida. My son is a thriving high school student and athlete.”
Stephanie Staras, Ph.D., assistant professor in the Department of Health Outcomes & Policy, wrote, “Dr. Thompson is amazing with my two living children. She delights in their accomplishments, knowledgably discusses their ailments, and truly loves them.”
Black pointed out that Thompson also is widely respected as an educator and mentor for medical students and residents at UF.
“Lindsay is a consummate teacher; it is a natural extension of her,” Black wrote. “She has had a tremendous impact on our community in Alachua County, Florida and an extraordinarily positive impact on innumerate students, residents, fellows and colleagues. I can’t count the number of medical students and residents who idolize her. She is who they think about when they look forward ten to twenty years and think about what is possible.”
Staras wrote, “I am certain there is no better person to have trained 30 residents. These doctors bring [Thompson’s] same joy, compassion, knowledge and grace into the community. I know because I have recruited them to participate in my studies and they can’t wait to tell me that Lindsay trained them.”
Thompson will accept the award at the 2017 AAP National Conference and Exhibition in Chicago on Saturday, September 16.
“I am humbled and honored to have been recognized by the American Academy of Pediatrics,” Thompson said. “What I most appreciate is how students, peers and colleagues came together to support me for this nomination. That in itself made me feel overwhelmed and supported.”
The OneFlorida Clinical Research Consortium will serve as the recruitment center for the WARRIOR (Women’s Ischemia Trial to Reduce Events In Non-Obstructive CAD) trial and the research team is currently seeking interested OneFlorida partners to establish clinic sites to recruit patients.
The three-year multicenter study funded by the Department of Defense will investigate health outcomes of women with non-obstructive coronary artery disease (CAD) who are randomized to receive either intensive medical therapy (IMT) or usual care. The researchers plan to recruit 4,422 women with non-obstructive CAD across 50 sites, including VA and active duty military hospitals and clinics, and the OneFlorida Clinical Research Consortium Practice Network. The study will focus recruitment efforts on active duty and retired service women as well military dependents, but all women in the state of Florida who meet the criteria are eligible. Each center is asked to enroll 80 participants over a 15-month period and follow them for up to three years. Data will be collected using a web-based data capture system.
Co-principal investigators Carl Pepine, M.D., Professor of Medicine, and Eileen Handberg, Ph.D., ANP, Research Professor of Medicine in UF’s Division of Cardiology, hypothesize that IMT will reduce major adverse cardiac events by 20 percent compared to usual care. The primary outcomes are first occurrence of death, myocardial infarction, stroke/TIA, hospitalization for chest pain, or heart failure. Secondary outcomes include quality of life, health resource consumption, angina, cardiovascular death and primary outcome components.
To participate in the study, women must be at least 18 years old, clinically stable, with angina or equivalent symptoms severe enough to seek or have sought referral for coronary angiography or a coronary CT angiogram within the previous two years.
- Signs and symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization or coronary CT angiogram.
- Willing to provide written informed consent.
- Age ≥18 yrs.
- Non-obstructive CAD defined as <50% diameter reduction of a major epicardial vessel on invasive angiography within 2 years.
- History of noncompliance (with medical therapy, protocol, or follow-up).
- History of non-ischemic dilated or hypertrophic cardiomyopathy.
Documented ACS within previous 30 days.
- LVEF <40%, NYHA HF class III-IV, or hospitalization for HFrEF within 180 days.
- Stroke within previous 180 ds. or intracranial hemorrhage at any time.
- End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) <30 ml/min.
- Severe valvular disease or likely to require surgery/TVAR within 5 yrs.
- Life expectancy <3-yrs. due to non-cardiovascular comorbidity.
- Enrolled in a competing clinical trial.
- Prior intolerance to both an ACE-I and ARB.
- Pregnancy (all pre-menopausal females must have negative serum pregnancy test).
This trial will be one of the first major tests of OneFlorida’s ability to act as an independent research consortium for a large-scale medical intervention trial. We are looking forward to working with all of our clinical practice sites.
For more information, contact
Carl J. Pepine, M.D., Professor of Medicine (email@example.com), or Eileen Handberg, Ph.D., ANP, Research Professor of Medicine (Eileen.firstname.lastname@example.org), in the Division of Cardiovascular Medicine at the University of Florida. Phone: 352-273-9082
OneFlorida partners are encouraged to get SMART before January 28, 2018.
By joining the SMART IRB Reliance Platform now, OneFlorida partners will have more flexibility in complying with a new National Institutes of Health (NIH) policy that requires the designation of a single IRB of record for all NIH-funded multisite studies involving human subjects. The new policy takes effect on January 28, 2018.
The National Center for Advancing Translational Sciences (NCATS) developed the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB to give researchers a flexible option for setting up a single IRB of record for their multisite studies. The SMART IRB includes
- A reliance agreement enabling eligible institutions that join the SMART IRB to cede review of human subjects research to the single IRB of record.
- A standard operating procedures (SOP) guide to implementation among the institutions.
- A network of regional ambassadors to provide support for researchers and/or institutions that join the SMART IRB reliance agreement.
- A centralized online reliance system to support the review of protocols and agreements to cede review of the study.
What does the SMART IRB reliance agreement (aka joinder agreement) cover?
- Each participating institution elects whether to cede IRB review for a research study on a case-by-case basis. (Any collaborating institutions on an NIH-funded grant can serve as the IRB of record for the study provided the institution has an active IRB.)
- Participating institutions must consult with other collaborating institutions regarding the designation of a single IRB of record. Alternatively, at the time of an NIH grant submission, the lead PI should contact his or her local IRB to decide which IRB will be the single IRB of record.
OneFlorida will continue to offer its current central IRB model for researchers conducting human subjects research within the consortium. However, OneFlorida requests that all partners sign the SMART IRB master reliance agreement, a deliverable for the CDRN, before the NIH policy takes effect next January. Partners can review the SMART IRB website for information about the reliance agreement and download a copy of the agreement (https://smartirb.org).
Jane-Ann Norton, the IRB coordinator for the OneFlorida Clinical Research Consortium, will be available to answer questions for OneFlorida partners. She may be reached at email@example.com.
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