PCORI is an independent organization authorized by the U.S. Congress in 2010 as part of the Patient Protection and Affordable Care Act.
“These three projects are all outstanding examples of how translational research can benefit patients and health care providers by coming up with new and innovative ways to address some of our society’s most important health issues,” said Richard J. Barohn, M.D., chair of KU Medical Center’s Department of Neurology and director of Frontiers: The Heartland Institute for Clinical and Translational Research, a KU Medical Center-based institute that will support each project.
Projects approved for funding include:
- $7 million for a project that will establish a new network of nine medical centers in seven states committed to building a data set from electronic medical records that will be used to contribute to new research in the fields of breast cancer, obesity and amyotrophic lateral sclerosis (also known as ALS, or Lou Gehrig’s disease).
- $1.5 million for a new clinical trial that will evaluate four different drugs for the treatment of pain associated with neuropathy – a disabling condition in which a patient complains of pain, numbness and tingling in the arms and legs.
- $1.5 million for a trial that will examine the effectiveness of long-term nicotine replacement therapy for patients with chronic obstructive pulmonary disease (COPD).
Building the Greater Plains Collaborative
The largest of the awards will allow a KU Medical Center-led team of 10 different medical centers to spend the next 18 months developing a network to connect electronic medical record systems and building tools that can use patient data to answer specific research questions.
We’ll be able to see in real time if what’s working for breast cancer patients in Minnesota is leading to better results than what’s working for breast cancer patients in Texas,” said L. Russell Waitman, Ph.D., director of medical informatics and assistant vice chancellor for Enterprise Analytics at KU Medical Center, who is the principal investigator on the project.
The team includes Children’s Mercy, the Medical College of Wisconsin, the University of Nebraska Medical Center, the University of Iowa, the University of Wisconsin, the University of Texas-San Antonio, the University of Texas-Southwestern, the University of Minnesota and the Marshfield Clinic Research Foundation.
The universities, as part of a group called the Greater Plains Collaborative, will focus specifically on breast cancer, obesity and ALS. It will be part of a larger national network that has plans to reach millions of patients.
“This project is a huge step forward,” Waitman said. “We’re looking forward to helping to lead the national conversation about ways to advance scientific knowledge faster by creating better studies, analyzing data more quickly and helping to answer questions that come from patients themselves.”
Helping patients manage pain
The $1.5 million award from PCORI will test four different drugs to see which is the most effective for a specific group of peripheral neuropathy patients.
The three-year study, led by Barohn, will focus on patients whose neuropathy has no known cause.
Though diabetes is a common cause of the condition, for about 25 to 50 percent of patients with peripheral neuropathy – estimated to be 5 to 10 million patients in the United States – no cause is identified.
“This will help address a big unmet medical need,” Barohn said. “We asked neuropathy patients in our clinic about the symptoms they would most like help with, and pain was their most consistent answer. The results of this study will give patients and doctors important and practical information to help them select the drug that is most effective and has the fewest side effects.”
Evaluating long-term nicotine replacement for high-risk smokers
For smokers with chronic obstructive pulmonary disease (COPD) – a condition that includes both emphysema and chronic bronchitis – continued smoking can make the condition worse.
Most of these smokers realize this and try to quit, said Edward Ellerbeck, M.D., MPH, professor and chair of KU Medical Center’s Department of Preventive Medicine and Public Health, who is leading the three-year study that will involve 400 patients.
Researchers will try to see if using long-term nicotine replacement therapy with a nicotine patch and the patient’s choice of nicotine gum or a lozenge combined with counseling can help increase quit rates for patients with COPD.
“Most smokers who try to quit ‘cold turkey’ aren’t successful,” Ellerbeck said. “We want to evaluate the effectiveness of long-term nicotine replacement therapies to see if it can be more successful in helping patients cut back on the amount they smoke.”
All awards, including proposed amounts and project periods, are approved by PCORI’s Board pending a business and programmatic review by PCORI staff and completion of a formal award contract.