Wednesday, August 20, 2014

KU School of Medicine approved for $2 million funding award by the Patient-Centered Outcomes Research Institute

KANSAS CITY, Kan. —  A research team at the University of Kansas School of Medicine has been approved for a $2 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to address tobacco use among African-Americans who do not smoke on a daily basis.

The study is one of 33 proposals PCORI approved for funding on July 29 to advance the field of patient-centered comparative effectiveness research (CER) and provide patients, health care providers and other clinical decision makers with information that will help them make better-informed choices.

Nikki Nollen, Ph.D., associate professor of preventive medicine and public health, will lead the research project at KU. To date, no studies have explored treatment options for non-daily smokers and, as a result, treatment guidelines are not available to guide patients or health care providers.

The study calls for 384 African-American nondaily smokers to receive either five sessions of quit-smoking counseling or five sessions of counseling in combination with 12 weeks of the participant’s choice of nicotine patch, gum, or lozenge.

At 12 and 26 weeks, Nollen and her colleagues will compare the two treatments on their effects on quitting smoking, exposure to nicotine and cancer-causing agents, number of days abstinent and side effects.

“The program will be the first to examine treatment options for non-daily smokers and could directly contribute to the first evidence-based guidelines for treating the 9.7 million U.S. adult non-daily smokers for whom no guidelines currently exist,” Nollen said.

One out of four African-Americans is a nondaily smoker. Research has shown that African-Americans have higher rates of disease and death at lower levels of smoking than other groups.

Nollen said that African-American nondaily smokers have “surprisingly high” levels of nicotine and cancer-causing agents in their bodies, making them a priority group for study. Nollen and her colleagues will work with the participants, health care providers and other stakeholders in the design of the materials and the interpretation of the results.

The award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract to KU. “PCORI grants are focused specifically on research that can have an immediate effect on how we treat patients,” said Edward Ellerbeck, M.D., M.P.H., the Sosland Family Professor and Chair of Preventive Medicine and Public Health at KU. “Dr. Nollen’s research will have important implications for how doctors right here in Kansas approach the treatment of non-daily smokers.”

PCORI is an independent, non-profit organization authorized by Congress in 2010 to fund CER that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed health and healthcare decisions. PCORI is committed to seeking input from a broad range of stakeholders to guide its work.

“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Joe Selby, M.D., M.P.H. “We look forward to following the study’s progress and working with KU to share the results.”

Nollen's study and the other projects approved for funding by PCORI’s Board of Governors on July 29 were selected from 325 applications submitted to PCORI's funding announcements issued in September 2013.

They were selected through a highly competitive review process in which patients, clinicians, and other stakeholders joined clinical scientists to evaluate the proposals.

Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria.

PCORI has approved nearly $549 million to support 313 research studies and initiatives since it began funding research in 2012. For more information about PCORI funding, visit