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Multi-institutional Workshop Identifies the "Known Unknowns" of Opioid Crisis

In a quote that has been repeated so often that it has almost become cliché, Secretary of State Donald Rumsfeld once answered a question about weapons of mass destruction by saying, "There are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns – the ones we don't know we don't know."

workshop graphic

The concepts of known knowns, known unknowns, and unknown unknowns apply not only to intelligence and politics, but to any discipline where the gathering of knowledge is paramount. So it was fitting that a workshop on the devastating opioid crisis began by invoking this quote from Rumsfeld.

The all-day event, called "Developing a Research Agenda for Addressing the Opioid Epidemic in NC," was held on May 16, 2018 at the Research Triangle Park (RTP) Conference Center in Durham. To kick off the discussion, Aaron McKethan, PhD, Chief Data Officer at the N.C. Department of Health and Human Services (NC DHHS), explained that the meeting was unconventional, by design.

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The ABCs of DSMBs: CTSA Program hubs work together to produce much-needed training manual

"By combining expertise from so many different organizations, we were able to truly address universal concepts and make a resource that's applicable to a wide range of scientists and researchers"
- Tamsin Knox, associate director of Regulatory Affairs at Tufts Clinical and Translational Science Institute and DSMB Training Manual editor.

cover of DSMB manual

Monitoring patient safety and protecting patient data is without question one of the most important aspects of clinical research. One of the ways researchers look to do this is through the use of a Data and Safety Monitoring Board (DSMB) – a group of people who monitor the progress of a trial and review safety data in an ongoing manner. However, until recently, there's been little guidance related to DSMB practices. In response, a group of cross-hub Clinical and Translational Science Award (CTSA) Program members have produced an online DSMB Training Manual.

The manual, which is the work of the CTSA Program Collaborative DSMB Workgroup, provides training, resources and information for Principal Investigators, DSMB members, IRB members, biostatisticians and research staff alike on how to work effectively with DSMBs.

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TraCS-funded research: lung cancer screening

Doctor-patient discussions neglect potential harms of lung cancer screening, study finds

UNC Lineberger researchers led by Daniel Reuland, MD, MPH, report in JAMA Internal Medicine that their analysis of 14 audio-recorded office visit discussions between doctors and patients found the quality of the conversation about lung cancer screening was "poor" and discussion of the potential harms of screening was "virtually nonexistent." In addition, the doctors spent less than a minute, on average, discussing the issue.

UNC Lineberger's Daniel Reuland, MD, MPH
UNC Lineberger's Daniel Reuland, MD, MPH

Although national guidelines advise doctors to discuss the benefits and harms of lung cancer screening with high-risk patients because of a high rate of false positives and other factors, those conversations aren't happening the way they should be, according to a study by researchers from the University of North Carolina Lineberger Comprehensive Cancer Center.

Lung cancer screening is recommended for high-risk current and former smokers, but because of the potential harms of screening, the U.S. Preventive Services Task Force and other organizations advise physicians and patients to discuss the potential risks and benefits of screening. UNC Lineberger researchers report in JAMA Internal Medicine that their analysis of 14 audio-recorded office visit discussions between doctors and patients found the quality of the conversation about lung cancer screening was "poor" and discussion of the potential harms of screening was "virtually nonexistent." In addition, the doctors spent less than a minute, on average, discussing the issue.

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UNC Health Care site of Adaptable study exceeds enrollment target

Enrollment of UNC Health Care System (UNCHCS) patients into the multi-site Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study has reached 581 participants, exceeding the UNCHCS site's original enrollment target of 500 participants.

The ADAPTABLE study is a three-year pragmatic clinical trial comparing two different doses of daily aspirin to evaluate which dose is more effective at preventing heart attacks and strokes for patients with cardiovascular disease. The study is being conducted at sites across the United States, with a recruitment goal of 15,000 participants.

“Darren
Darren DeWalt, MD, MPH

At UNCHCS, the ADAPTABLE study is led by Darren DeWalt, MD, MPH, Chief of the Division of General Medicine & Clinical Epidemiology at the University of North Carolina at Chapel Hill School of Medicine and the site PI.

"Recruitment is one of the most challenging aspects of many studies," said DeWalt. "Our ADAPTABLE team worked closely with TraCS to streamline recruitment processes through email and MyUNCChart. These methods enabled us to exceed our goal with modest resources."

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Michelle Maclay, Communications Director