Addressing Questions on Treatment and Prevention
More than one-third of adults and one in six children in the U.S. are considered to be obese. The Patient-Centered Outcomes Research Institute (PCORI) has approved $9 million to fund two research studies on prevention and treatment of obesity.
One study will examine three main methods of bariatric, or weight loss, surgery to provide patients and those who care for them with information on the comparative benefits and potential risks of each procedure. The other study will look at the effects of different types of antibiotics given to infants and young children on their weight in later childhood.
Both studies will use PCORnet, the National Patient-Centered Clinical Research Network, and its secure data network, to answer these questions. The research will also demonstrate PCORnet’s capacity to conduct observational research studies faster and with greater volumes of data than is possible through conventional ways of doing research, while ensuring patients’ privacy. Observational studies involve review and analysis of information on patients’ experiences with care collected in medical records.
The PCORnet bariatric study will examine three common types of bariatric surgery: gastric bypass, adjustable gastric banding and sleeve gastrectomy. The use of bariatric surgery to treat severe obesity has increased over the past 20 years, but there is inadequate evidence about the benefits, complications, potential risks and other outcomes associated with each procedure. This is especially true for adolescents.
The two-year observational study will address three specific objectives:
- Compare how patients’ weight loss and regain differs across the three bariatric surgical procedures
- Compare rates of diabetes improvements or relapse over time after surgery
- Research the frequency of complications or harms following these procedures
The study will review data from records of 60,000 patients who had one of these three procedures in the past 10 years. The study will include information on 17,000 people with diabetes and 900 adolescents ages 12-19 who have had bariatric surgery.
Antibiotic Use in Infants and Obesity Study
The PCORnet study on childhood obesity will look at the relationship between antibiotic use in the first two years of life and weight gain in later childhood. Previous research has shown a link between the use of antibiotics, particularly wide-spectrum antibiotics, and an increased risk for obesity.
The observational study will address three specific objectives:
- Compare the effects of different types, timing, and amount of antibiotics used in the first two years of life with BMI and obesity at ages 5 and 10
- Compare the effects of antibiotic use on rates and patterns of children’s growth during their first five years
- Explore how different factors such as gender, race/ethnicity, geographical location, or characteristics of the mother such as her BMI or type of delivery may impact outcomes
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, pediatricians, and other healthcare stakeholders make better informed decisions about using antibiotics in early childhood.
In each study, patients’ health records will be maintained securely behind the firewalls of the individual health systems that make up the participating PCORnet partner networks. The research teams will receive general information combined from many records that can’t be linked to individual patients unless the patients agree to share identified information.
PCORnet will provide access to data from large and diverse populations. PCORnet combines the knowledge and insights of patients, caregivers and researchers in a collaborative network with carefully controlled access to rich sources of health data.
PCORnet is designed to allow a range of clinical research studies to be conducted more efficiently and less expensively than traditional research by harnessing the power of clinical data gathered in real-world patient care settings. Patients and family caregivers have a central role in deciding the rules under which PCORnet operates, including developing principles and processes for safeguarding data privacy and security as well as deciding what research questions to study.
PCORnet is an initiative of PCORI, which to date has approved or awarded $260 million to develop PCORnet and conduct demonstration research studies using its resources.