Quick Hits Newsletter – Fall 2016
Research & Infrastructure Updates
OneFlorida Study Updates
PCORI Funds Three Projects to Address Concerns of Health System Leaders, Patients through CDRN Collaborations
The OneFlorida Clinical Research Consortium received funding from the Patient-Centered Outcomes Research Institute (PCORI) to collaborate on three projects that seek to address a variety of pressing concerns among health systems leaders.
The projects aim to impact the quality of care that patients receive and will be led by three different Clinical Data Research Networks, or CDRNs, which bring together health systems, patients, clinicians, researchers and others to develop data infrastructure that supports patient-centered research. Together, they are part of a national research data network called PCORnet, funded by PCORI.
The projects include:
- Automating Quality and Safety Benchmarking for Children: Meeting the Needs of Health Systems and Patients – led by Kathleen Walsh, M.D., of Cincinnati Children’s Hospital Medical Center, a network member of PEDSnet.
- Identifying and Predicting Patients with Preventable High Utilization – led by Rainu Kaushal, M.D., M.P.H., chair of healthcare policy & research at Weill Cornell Medicine, a network member of the New York City CDRN.
- The Impact of Patient Complexity on Healthcare Utilizations – led by Scott Fields, M.D., MHA, chief medical officer of the Oregon Community Health Information Network, a network member of the ADVANCE CDRN.
“The OneFlorida Clinical Research Consortium is excited to participate in these three important projects, which aim to serve our health system partners and provide better care for patients nationwide,” said Betsy Shenkman, Ph.D., co-director of the OneFlorida Clinical Research Consortium, who will serve as the site principal investigator on the three projects.
OneFlorida partners who will participate in these projects as part of the OneFlorida Data Trust include UF Health, Orlando Health, Tallahassee Memorial Hospital, Health Choice Network and Florida Hospital. The OneFlorida Data Trust also houses Florida Medicaid Pediatric Claims Data.
Learn more about each project here.
OneFlorida CRC Participates in First Wave of PCORnet Observational Studies – Focuses on Addressing Questions About Obesity Treatment and Prevention
In February 2016, the National Patient-Centered Clinical Research Network launched its first wave of observational studies, focusing on obesity treatment and prevention. The OneFlorida Clinical Research Consortium is a participant in both of the obesity observational studies, which will look at currently existing patient records in the OneFlorida Data Trust to observe a specific set of outcomes.
One study, the Antibiotic Use in Infants and Obesity Study, will examine the relationship between antibiotic dosages in the first two years of a patient’s life and weight gain at later stages in life. The OneFlorida site principal investigator (PI) for the Antibiotic Study is David Janicke, Ph.D., ABPP, co-leader of the OneFlorida Clinical Research Consortium Obesity Work Group and professor at the University of Florida in the Department of Clinical and Health Psychology. The PI for the nationwide study is Jason Block, M.D., MPH, assistant professor in the Department of Population Science at Harvard Medical School.
The second study, the Bariatric Surgery Study, will look at three common methods of bariatric surgery and compare their risks and benefits by monitoring the outcomes of patients who have had one of the three procedures. The OneFlorida site PI for the Bariatric Surgery Study is Steven Smith, M.D., co-leader of the OneFlorida Clinical Research Consortium Obesity Work Group and chief scientific officer for Florida Hospital. The program manager is Rebecca Essner, Ph.D., M.S., CCDM, who is also a member of the OneFlorida Clinical Research Consortium Obesity Work Group and a research scientist for Data and Development at Florida Hospital. he PI for the nationwide study is David E. Arterburn, M.D., MPH, of Group Health Research Institute.
Both of these studies will utilize data from three OneFlorida partners: UF Health, Tallahassee Memorial Hospital and Orlando Health, and they have been approved by the OneFlorida IRB. The Antibiotic Study is waiting for the results of study-specific data characterization queries from its PCORnet Coordinating Centers Harvard Pilgrim Healthcare Institute. The consortium passed the study characterization query from the study’s PCORnet Coordinating Center, Group Health Research Institute, for the Bariatric Surgery Study. The study specific characterization queries are unique queries designed to test the PCORI Common Data Model tables that will be needed for the study. This process will ensure that all participating sites will contribute data in a standardized format. Once The OneFlorida Clinical Research Consortium passes the characterization for both studies, data contribution can begin. These studies will be conducted over a two-year period, with conclusion scheduled for January 31, 2018. The research results will be disseminated shortly afterwards.
The OneFlorida Clinical Research Consortium Invited to Participate in Two PCORnet National Clinical Trials
The National Patient-Centered Clinical Research Network (PCORnet) has selected the OneFlorida Clinical Research Consortium as a participant in two large-scale national clinical trials, ADAPTABLE and INVESTED. These trials are longitudinal trials, meaning the same patients contribute data over a long period of time, and are designed to both monitor cardiovascular outcomes and test the infrastructure of the PCORnet network. PCORnet is an initiative started by the Patient-Centered Outcomes Research Institute (PCORI), designed to make conducting clinical research easier, more efficient, and less costly. It is able to accomplish these goals by establishing collaborations between multiple partner networks, with each partner contributing large amounts of health care data.
The Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) trial seeks to determine the ideal dosage of aspirin for patients to prevent heart attacks. While aspirin has long been prescribed to prevent heart attacks, this is the first clinical trial that aims to identify the best dose. The trial will randomly assign patients to two common aspirin dosages, 81mg or 325mg, and will focus on monitoring the changes in patient outcome measures over a two-year period. A total of eight Clinical Data Research Networks (CDRNs) have been invited to participate, and PCORnet has set an enrollment target of 20,000 participants. The OneFlorida Clinical Research Consortium has been tasked with enrolling 2,200 participants.
Eileen Handberg, Ph.D., ARNP, member of the OneFlorida Hypertension Team, states that “We are excited to initiate this study at OneFlorida. We have a history of successful recruitment for large cardiovascular disease studies and are looking to try and enroll well beyond the goal of 2,200 participants. Our patients want to be a part of the answer.”
The second trial, entitled Influenza Vaccine to Effectively Stop CardioThoracic Events and Decompensated Heart Failure (INVESTED) investigates the role of high-dose influenza vaccine in reducing cardiovascular events, since several analyses have shown that the vaccine provides cardiovascular benefits, particularly at high doses. The trial aims to enroll participants into either a high-dose or standard-dose group for the influenza vaccine and monitor their outcomes over a three-year period. This trial will test the hypothesis that the high-dose vaccination will reduce cardiopulmonary hospitalizations or composite death when compared with the standard-dose recipients. The OneFlorida Clinical Research Consortium has been assigned to recruit 20 patients, but according to Dr. Handberg, “I’m hoping that we can exceed this goal as well.”
The ADAPTABLE study was approved by the OneFlorida IRB. INVESTED is being submitted to the NCATS SMART IRB. Recruitment for both studies will be coordinated by the OneFlorida Integrated Clinical Research Program.
To learn more about the NCTS SMART IRB, please click here.
The OneFlorida Clinical Data Research Network is officially “Approved for Research,” after a rigorous review and data characterization cycle by PCORnet, the Patient-Centered Outcomes Research Institute’s national research data network.
With this status, the OneFlorida Clinical Research Consortium is now eligible for additional funding and to participate in studies through PCORnet. In addition, it enables Floridians to engage in national research studies that they previously would not have had access to and on a much larger scale than before, which could ultimately impact the health of the state’s communities.
The OneFlorida Data Trust, which serves as the statewide data repository for the OneFlorida Clinical Data Research Network (CDRN), currently includes the de-identified data of more than 8.2 million Floridians from UF Health in Gainesville and Jacksonville, Tallahassee Memorial Healthcare, Orlando Health, Health Choice Network, Florida Medicaid and Florida Hospital. The Data Trust will allow researchers nationwide to conduct studies on de-identified patient data to identify trends and procedures that improve individuals’ health as well as contact patients who have consented for engaging in research that could improve their health.
“This incredible accomplishment was only possible due to the hard work and perseverance of multiple partners across this network,” said Bill Hogan, M.D., M.S., co-principal investigator of the OneFlorida Clinical Data Research Network and director of biomedical informatics at the University of Florida Clinical and Translational Science Institute. “I would especially like to acknowledge the leadership of many individuals across the state who believed that a centralized data repository was not only possible but also vital for speeding data-driven research insights to the patients who need them.”
Read more about this statewide accomplishment here.
In September, the Patient-Centered Outcomes Research Institute (PCORI) contacted all stakeholders with a call for research questions that address difficulties faced by patients with cardiovascular disease. The OneFlorida Clinical Research Consortium Hypertension Team forwarded the call on the OneFlorida listserv with the hopes of working with clinicians, patients, and researchers across the consortium to submit entries to PCORI.
The team received five entries:
- Francois Modave, University of Florida: Can we develop an effective mHealth strategy to help such patients undertake an exercise regimen, under physician supervision, in order to improve cardiac rehabilitation, or lower symptoms of autoimmune conditions, and thus improve quality of life in general?
- Brian Johnson, Bond Community Healthcare: Are there disparities in stroke prevention treatment plans between Florida’s insured and uninsured/underserved high-risk patients? Are there disparities in antithrombotic therapies prescribed for Florida’s high-risk insured vs. uninsured/underserved patients?
- Claudia Harris, Citizen Scientist Program: I would love to see comparative data on various medications used to control BP by history, weight, age, diet, environment, demographics, etc.
- Charlene Krueger and Michael Weiss, University of Florida: In newborns that have suffered a stroke or severe hypoxic-ischemic brain injury at birth, is there an association between spectral heart rate variability and positive response to therapeutic hypothermia treatment as indicated by occurrence of minimal to no brain injury based on Magnetic Resonance Imaging?
- Allison Siegel, Florida Hospital: How should physicians frame informed consent to parents of infants with hypoplastic left heart syndrome? Which subspecialty should offer informed consent: perinatologist, neonatologist, cardiologist, surgeon? As Norwood has been attended by improved results, is it anachronistic to include compassionate care?
The Hypertension Team, led by Dr. Rhonda Cooper-DeHoff, reviewed the entries and hosted a meeting where they were discussed and refined. Feedback was provided by Cooper-DeHoff, Eileen Handberg, Ph.D., ARNP, and Katie Eddleton, MPH. The team will work with the entrants to send the submissions to PCORI on Thursday, Oct. 6.
We are excited to engage partners throughout the consortium in generating these questions. For more information on the “Call for Research Questions” please click here. If you have any questions about the Hypertension Team, contact Damian Alderman at firstname.lastname@example.org.
The OneFlorida Clinical Research Consortium has been named a sponsor in the American Board of Medical Specialties (ABMS) Multi-Specialty Portfolio Program. This designation allows the consortium to support physician involvement in quality improvement (QI) initiatives by offering Maintenance of Certification (MOC) credit.
MOC is composed of four components that physicians need to maintain board certification: professionalism; lifelong learning; assessment of knowledge, skills and judgment; and improvement in medical practice. The OneFlorida MOC program will enable physicians to earn Improvement in Medical Practice (Part IV) credit.
As a sponsor, the consortium will be able to award MOC Part IV credit to a variety of physician specialties through different research and physician-initiated QI projects. The first project to be offered will be for pediatricians and family physicians and will focus on incorporating discussions about tobacco use into routine clinical visits for adolescents.
The OneFlorida Clinical Research Consortium and the University of Florida Department of Pediatrics MOC program launched this fall and is open only to intervention practices in the tobacco research study at this time. The course will be open to any interested participants once the intervention phase of the study ends in Spring 2017.
For more information about the OneFlorida MOC program, please contact MOC Manager Janet Brishke at email@example.com.
The OneFlorida Minority Education Project mentees were at the University of Florida in Gainesville for the week of July 11-15. This on-campus experience allowed time for face-to-face meetings between trainees and their OneFlorida faculty mentors in addition to a special series of lectures and workshops.
The week’s activities kicked off with a powerful roundtable discussion featuring UF leaders in health research who come from minority backgrounds and featured advice regarding professional development and overcoming academic and research obstacles. MEP participants were joined by undergrad scholars in the Florida Prostate Cancer ReTOOL (Research Training Opportunities for Outstanding Leaders) Program. Other lectures focused on strategies for obtaining grant funding and on the meaning and power of big data in health systems research. In the afternoons, MEP trainees participated in the University of Florida’s CTSA-sponsored course Introduction to Clinical/Translational Research.
MEP trainees are working on year-long research projects in conjunction with OneFlorida faculty members. The program is funded by the James and Esther King Biomedical Research Program #4KB16. Learn more about the Minority Education Program here.
The OneFlorida Clinical Research Consortium is engaging stakeholders in a unique way through the Citizen Scientist Program. This program, a collaboration between the consortium and the UF Clinical and Translational Science Institute (CTSI), helps bridge the gap between researchers and community members. Citizen Scientists generally represent their own lay perspective rather than speak on behalf of a certain patient, community, or sociodemographic group. Some of the ways Citizen Scientists have assisted in furthering the mission of the consortium are:
- reviewing research proposals
- offering feedback on patient recruitment strategies
- serving on research study teams to give continued feedback
- participating in Translational and Implementation Science Studios, which are multidisciplinary roundtable discussions that aim to strengthen researchers’ proposals and ideas related to implementation science and pragmatic clinical trials.
- serving on Patient-Centered Outcomes Research Institute (PCORI) national committees
- representing the lay perspective on OneFlorida and CTSI oversight committees
The Citizen Scientist Program recently recruited three teens to serve on a separate Teen Citizen Scientist group, which will give feedback and advice on pediatric-oriented research studies. The teens have given feedback on a forthcoming iPad-based survey for teens on the intent to quit smoking and look forward to offering their perspectives on additional projects.
For more information on the program, including how to engage Citizen Scientists in your work, please contact program manager Janet Brishke at firstname.lastname@example.org.
Policies & Procedures
Read the approved policy here.
Read the approved policy here.
The UF Health Science Center Institutional Review Board (UF-HSC IRB) developed the OneFlorida IRB to streamline the submission process and facilitate the conduct of central review for research in multiple sites. Central IRBs have the obvious advantage of providing protocol review to multiple sites and\or investigators. Cooperative research conducted at all the facilities comprising OneFlorida could require the approval of up to 15 IRBs, which might take more than a year. The UF-HSC IRB developed a Co-Op IRB process, to enjoy the efficiencies of a central IRB while addressing the special needs of a local review. The Co-Op IRB consists of the UF-HSC IRB, with input from the non-UF IRB’s participating in the research. Under the Co-Op IRB there will only be one IRB submission; however, each local study site’s IRB will have input into the review and can insert local regulatory language. The OneFlorida IRB is built upon this Co-Op Model and all partners have agreed to participate.
The OneFlorida IRB has received eight new studies as well as revisions of existing studies, which has helped refine the process for approving the ancillary review. Thank you to all partners and investigators in the consortium for helping to develop this key aspect of our infrastructure!
Here are some helpful tips when performing the ancillary review:
The OneFlorida IRB now requires an approved Executive Committee Letter to be uploaded on the first page in question 4. In addition, the OneFlorida IRB coordinator, Jane-Ann Norton, must be added to the study as a coordinator. The function of the OneFlorida IRB coordinator is to review the submissions for the OneFlorida IRB required documents.
Ancillary review updates
1. What is the difference between “Approved” and “Not Approved” in the ancillary review?
- Approved – indicates that the site IRB does not have any issues with the study being performed at this location.
- Not Approved – indicates that the site IRB cannot approve the study being performed at the site for whatever reason.
2. How should I handle clarifications that arise with the submission?
- Contact the OneFlorida IRB coordinator, Jane-Ann Norton, at email@example.com or 352-294-5981 to assist with clarifications in the submission, OR
- The “Joint Review Form” features several questions that can be used to clarify the submission. The form is sent to you in your MOU package, or you can request the form from Jane-Ann.
3. What if a revision is needed to the site addendum?
- When the site addendum needs to have a revision the following steps are required:
- Save the addendum from the myIRB site,
- Turn on track changes,
- Make the changes in the addendum,
- Upload the tracked version of the addendum in the ancillary review.
4. What is needed to submit the ancillary review?
- Approval of the ancillary is required to have the study performed at the site.
- The ancillary will need to be approved even if the site has not yet submitted any data to the Data Trust.
- The site has a main PI for the study.
- The “Joint Review Form” is uploaded into the ancillary review
- The Addendum is uploaded into the ancillary review if any tracked changes have been done.
We look forward to facilitating the use of the OneFlorida IRB for partners state- and nationwide. Check the OneFlorida Quick Hits Newsletter regularly for tips and updates on the OneFlorida IRB.
The OneFlorida Clinical Research Consortium to Attend American Medical Informatics Association (AMIA) Annual Symposium
Several representatives from the OneFlorida Clinical Research Consortium will attend AMIA’s annual conference Nov. 12-16 in Chicago. The consortium will present a Learning Showcase on the OneFlorida Clinical Data Research Network as well as a presence in the exhibition hall. If you plan to attend, please email the Coordinating Center at OneFloridaOperations@health.ufl.edu, so we send you more details about the booth and event plans.
The OneFlorida Clinical Research Consortium will hold its third Annual Stakeholder Meeting this January at the Harrell Medical Education Building in Gainesville, Florida. We are pleased to announce that the executive director of the Patient-Centered Outcomes Research Institute (PCORI), Joe Selby, M.D., MPH, will be joining us. A networking event with research posters will be held on the evening of Wednesday, January 25, and the official meeting will occur on Thursday, January 26.
Please contact TaJuana Chisholm, Administrative Director of Operations, with any questions at OneFloridaOperations@health.ufl.edu.
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