About Us
- 2023 Annual Meeting
- About PCORI
- The PCORI Strategic Plan
- Governance
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
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Provide Input
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Past Opportunities to Provide Input
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
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Past Opportunities to Provide Input
- Leadership
Nearly one-fifth of American children have obesity, increasing their risk of many associated health problems. These include conditions historically considered adult problems: heart disease, type 2 diabetes, high cholesterol, high blood pressure, and liver disease. Obesity affects many aspects of an individual's physical and mental health; children with obesity, defined as being at or above the 95th percentile in body mass index of the Centers for Disease Control and Prevention’s growth charts, often face depression, low self-esteem, and bullying.
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In observance of National Childhood Obesity Awareness Month, we highlight some of the work PCORI has funded to better understand, prevent, and treat pediatric obesity (see box). One of our largest funded efforts is PEDSnet, a network with access to data from 5.1 million children—and growing. PEDSnet, which aims to find ways to provide the best medical care and best outcomes for children in all areas of health, has obesity as a major focus.
“Obesity is tied to so many other health conditions, and we’re seeing these disorders at younger and younger ages,” says Ihuoma Eneli, MD, a PEDSnet investigator and Director of the Center for Healthy Weight and Nutrition at Nationwide Children’s Hospital in Columbus, Ohio. PEDSnet, which is headquartered at the Children’s Hospital of Philadelphia, is one of the health system–based Clinical Data Research Networks that are part of PCORnet, the National Patient-Centered Clinical Research Network. This PCORI initiative is harnessing the power of data and unique partnerships to conduct important health research faster, more efficiently, and at lower cost than was previously possible.
“The quality of life of kids with obesity is similar to that of kids with cancer. This finding highlights the seriousness of the problem,” Eneli says. “PEDSnet should give us an idea of what works and what doesn’t.”
PCORI's Pediatric Obesity Focus
PCORI is funding, in addition to PEDSnet, a variety of research projects on childhood obesity. These include two large observational research studies using PCORnet data. Announced last year, these awards total $9 million.
One of these studies, based at Harvard Pilgrim Health Care Institute in Boston, investigates the relationship between antibiotic use in early childhood and risk of obesity through later childhood. Using data from about 600,000 children, this study evaluates whether the types, timing, and amount of antibiotics that children take in the first two years of life affects body mass index and obesity risk at ages 5 and 10.
The other PCORnet study, based at Group Health Cooperative in Washington State, is comparing the effectiveness of the three main types of weight loss surgery. This study looks at weight loss and regain, diabetes risk, and adverse effects. This bariatric surgery study is uncommon in that it includes adolescents among its participants.
In addition to the PCORnet-related projects, a major PCORI-funded study focuses on a well-known diabetes drug that has shown promise for weight management in studies of adults and children with bipolar disorder. In both children and adults, weight gain is a common side effect of antipsychotic medications often prescribed for that disorder. The study will see whether the diabetes drug metformin can help avoid obesity in children and teens, between 8 and 17 years old, who are taking an antipsychotic drug for bipolar disorder. Half of the 1,800 children in the study will take metformin in addition to receiving a healthy lifestyle program that encourages healthful eating and exercise; their weight will be compared to that of the other children, who will receive only the healthy lifestyle program.
Another PCORI-funded project looks at what worked for kids with obesity who successfully lowered their body mass index. The research team is trying to help other children use those strategies (see Learning from the Success Stories).
For more information, see a list of PCORI-funded projects focused on obesity, both in children and adults.
Firsthand Experience
Douglas Lunsford, a special education teacher in Utica, Ohio, has seen firsthand the need for such a research network. “My son has always struggled with obesity,” he says.
His teenage son lost weight by participating in a program at Nationwide Children’s Hospital focusing on nutrition, exercise, and social support, although in the two years since leaving the program, the teen’s weight has crept back up. “He is still much more aware of the impact that food has on his body, his health, and the way that he feels about himself,” Lunsford says.
It was through clinicians in that program that Lunsford got involved in childhood obesity research at the hospital. He helped develop a successful proposal for PCORI funding to use PEDSnet data to track connections between early exposure to antibiotics and obesity (see box). Lunsford is now the lead parent investigator for this antibiotics study and also participates in other PEDSnet activities.
Lunsford is concerned about his son’s risk of diabetes, a disease that runs in his family. In other ways, he reflects, his son has been “really lucky,” largely avoiding the stigma that many children with obesity experience. “He’s very tall, almost 6-foot-4, and he was always very friendly with everybody,” Lunsford says. “He really didn’t have to deal with a lot of bullying or a lot of teasing about his weight.”
The Power of Aggregating Data
PEDSnet is built around the idea that aggregating children’s data—about obesity and other conditions—from many sites will make it easier to detect trends in health and health care. “If we work across large collaborations, we can answer research questions faster and more clearly,” explains Charles Bailey, MD, PhD, the PEDSnet Data Coordinating Center director and an oncologist at Children’s Hospital of Philadelphia.
Having so much data also enables research on relatively rare diseases in children, says Bailey, a specialist in clinical research data. Also, having data from many locations allows researchers to pinpoint practices that work better, or worse, in children’s health care.
Bailey is enthusiastic about working with parents to make the data better represent children’s experiences. “For many families, the main question is, what can we learn to better take care of my child?” he says.
Amy Kratchman, a family consultant at Children’s Hospital of Philadelphia and parent representative of the PEDSnet steering board, says that the parents were influential in the network’s design. They emphasized the importance of making sure that parents of participants understand how their children’s data are being used.
Lunsford hopes that one result of PEDSnet will be an increasing awareness and sensitivity among physicians about childhood obesity. “We have encountered physicians who said, ‘Oh, you just need to go on a diet. Oh, you just need to do more exercise,’” he says. “PEDSnet is aware of the many different factors that can lead to obesity in children.”
He hopes that the use of the millions of data points in PEDSnet will enable doctors to individualize treatment plans based on a child’s risk factors—and then test whether that individualized treatment actually improves a child’s outcomes.
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The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.
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