PCORI approves Group Health for $4.5 million obesity study

Study leader Dr. David Arterburn will use PCORnet, new national clinical research network, to speed results

The Patient-Centered Outcomes Research Institute (PCORI) has approved David Arterburn, MD, MPH; Kathleen McTigue, MD, MPH, MS; and Neely Williams, MDiv, for a two-year $4.5 million funding award to study bariatric (weight-loss) surgery for obesity. Dr. Arterburn is a senior investigator at Group Health Research Institute and a Group Health Physician; Dr. McTigue is a physician and associate professor of medicine and epidemiology at the University of Pittsburgh; and Ms. Williams is a bariatric patient and community engagement consultant in Nashville, Tenn. The study aims to produce results faster and more efficiently by using PCORnet, the National Patient-Centered Clinical Research Network.

This study will compare the health benefits and safety associated with the three main methods of bariatric surgery: Roux-en-Y gastric bypass, adjustable gastric banding, and sleeve gastrectomy. The goal is to give patients and their health care providers the information they need to choose which type of surgery is best for them.

Large study can answer questions definitively

This is important because, although use of bariatric surgery to treat severe obesity has increased over the past 20 years, evidence is inadequate about the benefits, potential risks, and other outcomes associated with each procedure—particularly in teens, and for sleeve gastrectomy.

“This will be one of the largest studies of bariatric surgery ever conducted, including data from more than 60,000 bariatric patients at more than 53 health care organizations, including Group Health,” said Dr. Arterburn, who is also an affiliate associate professor in the University of Washington (UW) Department of Medicine. Included will be more than 17,000 people with diabetes and 900 adolescents: the largest-ever cohort of teens getting this surgery.

Engaging patients and their priorities

 “We will address questions that really matter to patients and their providers,” Dr. Arterburn said. “We’ll compare the most common bariatric procedures head-to-head to find out how they rank in weight loss, weight regain, diabetes control, and major complications or harms.”

As with other PCORI-supported projects, patients and other stakeholders have been fully engaged in developing this study and will be engaged in all of its stages, including selecting outcomes that patients care about most. And a series of focus groups involving adults and children with severe obesity are planned to identify their preferences and opinions about whether to have bariatric surgery, which procedure to use, and delivery of follow-up care after the surgery.

“We’ll look closely at important patient subgroups—including teens and older adults, men and women, and all major racial/ethnic groups—to find out which procedures work best for which patients,” Dr. Arterburn said.

This study award continues PCORI’s efforts to develop PCORnet, a large, collaborative research initiative designed to link researchers, patient communities, clinicians, and health systems in productive research partnerships that leverage the power of large volumes of health data maintained by the partner networks. PCORnet will enable the nation to conduct clinical research more quickly and less expensively than is now possible and will ensure that research focuses on the questions and outcomes that matter most to patients and those who care for them. PCORnet has established 11 Clinical Data Research Networks or CDRNs, which have been developing the PCORnet infrastructure. Group Health is part of the Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) CDRN.

Companion study

At the same time, PCORI also approved a PCORnet study on childhood obesity that is being led by Harvard Pilgrim Health Care, and Group Health will also contribute data to that study. It will look at the relationship between the antibiotics often given to babies and toddlers and the risk for obesity later in childhood.

To date, PCORI has approved or awarded over $260 million to develop PCORnet and conduct demonstration research studies using its resources. The funding award to Dr. Arterburn has been approved by PCORI’s Board pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.   

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.4 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.