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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
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WASHINGTON, DC — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $9 million to fund two research studies focused on the treatment and prevention of obesity in children and adults. The research teams will use the partnerships and secure data resources of PCORnet, the National Patient-Centered Research Network, to fill key evidence gaps about this important health issue.
One study will compare the health benefits and safety associated with the three main methods of bariatric, or weight loss, surgery to provide patients and their healthcare providers the information they need to choose which is best for them. The other will compare the effects of different types of antibiotics on young children’s weight and risk for obesity in later childhood.
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 have obesity, as are one in six children, making obesity one of our nation’s most significant public health challenges,” said PCORI Executive Director Joe Selby, MD, MPH. “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.”
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.
Use of bariatric surgery to treat severe obesity has increased over the past 20 years, but there is inadequate evidence about the benefits, potential risks, and other outcomes associated with each procedure. This is especially true for adolescents.
The PCORnet bariatric study will examine the three most common procedures: gastric bypass, adjustable gastric banding, and sleeve gastrectomy. It will review data from records of 60,000 patients who had one of these three procedures in the past 10 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. More details on the study can be found on PCORI’s website.
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, pediatricians, and other healthcare stakeholders make better informed decisions about using antibiotics in early childhood. More details can be found online.
The funding awards have been approved by PCORI’s Board pending completion of a business and programmatic review by PCORI staff and issuance of formal award contracts.
The obesity studies are the second effort to demonstrate PCORnet’s capacities to conduct patient-centered health research faster and more efficiently than is possible now with conventional research tools and approaches. PCORI awarded $14 million for the first randomized clinical trial to be conducted in PCORnet earlier this year.
To date, PCORI has approved or awarded more than $260 million to develop PCORnet and conduct demonstration research studies using its resources.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at www.pcornet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is the nation’s leading funder of patient-centered comparative clinical effectiveness research (CER). By comparing two or more health or healthcare approaches, CER generates evidence that helps people make better-informed decisions and improves healthcare delivery and outcomes. PCORI takes a holistic approach to its work, ensuring that patients and other health decision makers are engaged as partners throughout the research process, supporting dissemination and implementation of results in practice and strengthening clinical research infrastructure to advance patient-centered CER. PCORI is an independent, non-profit organization authorized by Congress.