JANUARY 20, 2017 BY MOLLY SKUBAK

What We're Learning: PCORnet Bariatric Study

Jeanne M. Clark, MD, MPH, FACP, is the lead PaTH Protocol Principal Investigator for the PCORnet Bariatric Study.

Obesity is a significant problem in the United States, affecting more than one third of adults and about 12.7 million children and adolescents. It is connected to a myriad of other health issues including heart disease, stroke, type 2 diabetes, and certain types of cancer. Bariatric surgery is sometimes used to treat severe obesity, but there have been few high-quality, long-term studies conducted to compare the benefits and risks of different bariatric procedures.

The National Patient-Centered Clinical Research Network (PCORnet) is hoping to change that with the PCORnet Bariatric Study. One of the network’s first observational studies, the PCORnet Bariatric Study, or PBS, will involve 11 of PCORnet’s Clinical Data Research Networks, including PaTH. PBS will compare data from 56 healthcare organizations. The study team expects to analyze data from more than 60,000 bariatric patients, 900 adolescent bariatric patients, and 17,000 patients with diabetes. This large patient base will allow researchers to consider outcomes in general as well as in respect to specific patient groups, such as adults over 65 and individuals of minority racial/ethnic backgrounds.

Julie Tice is a PaTH Patient Partner with the PCORnet Bariatric Study.

"This is a broader population than we’ve seen and more representative," says Jeanne M. Clark, MD, MPH, FACP, Professor of Medicine and Epidemiology and Director of the Division of General Internal Medicine at Johns Hopkins University. Dr. Clark is the lead PaTH Protocol Principal Investigator for PBS.

The study is looking into the one-, three-, and five-year benefits and risks of the three most common bariatric surgeries – Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy – with a focus on changes in weight, rates of remission and relapse of diabetes, and risk of major adverse events.

"This is a way to look at a much more representative group of people who undergo bariatric surgery under modern care and see how they do both in terms of benefits and some of the downsides we see with complications," says Dr. Clark.

PBS will include a series of focus groups involving adults and adolescents with severe obesity to identify patient preferences and opinions about whether to undergo bariatric surgery, which bariatric procedure to have, and the delivery of follow-up care after bariatric surgery.

"Patients have been very involved since the beginning," says Kathleen McTigue, MD, a co-Principal Investigator for the PCORnet Bariatric Study. "They were part of the initial planning group, and we have a patient co-principal investigator." Julie Tice, a patient partner from the Penn State site, represents PaTH on the study.

PBS also aims to help develop processes and procedures to support future comparative effectiveness studies using the PCORnet research network.

This will pave the way for a lot of future research in terms of methodology," says Dr. Clark.

The study’s first analytic data was returned to PCORnet recently, including data from Pitt, Penn State, Temple, University of Utah, and Geisinger.

The PBS research team released its first findings at a scientific meeting this past summer and presented three posters at the Obesity Week conference in early November. Poster topics to date include patient engagement and the use of health record data to assess bariatric outcomes.

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