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New obesity studies

Studies to examine bariatric surgery and childhood obesity

US$9 million for research on bariatric surgery and childhood obesity

The Patient-Centered Outcomes Research Institute (PCORI) has approved US$9 million to fund two research studies focused on the treatment and prevention of obesity in children and adults. The first study, the PCORnet bariatric study, will compare the health benefits and safety associated with gastric bypass, adjustable gastric banding and sleeve gastrectomy to provide patients and their healthcare providers the information they need to choose which is best for them. The second study will compare the effects of different types of antibiotics on young children's weight and risk for obesity in later childhood.

The bariatric study will review data from records of 60,000 patients who had one of the three procedures in the past ten years. It will compare patients' weight loss and regain, rates of diabetes improvement or relapse, and the frequency of complications or harms. The study will include information on 17,000 people with diabetes and 900 adolescents who have had bariatric surgery. From the of 60,000, the study will gather 50 percent of its data on gastric bypass, 10 percent on gastric banding and 40 percent on sleeve gastrectomy procedures. The study will involve ten of PCORnet’s Clinical Data Research Networks (CDRNs) including 53 healthcare organisations.

The study has two additional goals: 1) the development of infrastructure - in the form of study processes and procedures - to support future comparative effectiveness studies using the PCORnet distributed research network, and 2) the identification of patient preferences and opinions about (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilise; and (c) the delivery of follow-up care after bariatric surgery through a series of focus groups involving adults and children with severe obesity.

The two-year, US$4.5million study, will be led by Principal Investigator Dr David Arterburn a Group Health physician and a Group Health Research Institute associate investigator and affiliate associate professor of medicine at the University of Washington School of Medicine.

Each study will deliver answers by reviewing health information from the records of thousands of patients. The records are maintained in secure systems by the individual PCORnet health data networks participating in the studies. The studies will demonstrate PCORnet's capacity to conduct such observational research faster and with a greater volume of data than is possible through conventional ways of doing research, while ensuring patients' privacy.

"More than one-third of America's adults are considered to be obese as are one in six children, making obesity one of our nation's most significant public health challenges," said PCORI Executive Director, Dr Joe Selby. "The effectiveness and safety of weight loss surgery and the potential for weight gain associated with antibiotics frequently given to young children are important issues that matter greatly to patients and those who care for them. Our support for these studies aims to give patients, parents, and their clinicians the evidence they need to make informed decisions about their care."

The PCORnet study on childhood obesity will look at the relationship between the antibiotics frequently given to infants and young children during the first two years of life and the risk for obesity in later childhood. Recent research has shown a link between the drugs and increased weight.

The study will assess data from the records of roughly 600,000 patients to compare the effects of different types of antibiotics on children's growth and weight at ages 5 and 10. It will also look at the effects of the frequency of the drugs' use as well as other factors that could also affect weight. The results will provide information to help patients, paediatricians, and other healthcare stakeholders make better informed decisions about using antibiotics in early childhood.

The obesity studies are the second effort to demonstrate PCORnet's capacities to conduct patient-centred health research faster and more efficiently than is possible now with conventional research tools and approaches. PCORI awarded US$14 million for the first randomized clinical trial to be conducted in PCORnet earlier in 2015.

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