- 2023 Annual Meeting
- The PCORI Strategic Plan
- Clinical Effectiveness and Decision Science
- Dissemination and Implementation
- Evaluation and Analysis
- Healthcare Delivery and Disparities Research
- PCOR Infrastructure & Innovation
- Our Vision & Mission
- Financial Statements and Reports
- The PCORI Strategic Plan
- Board of Governors
- Methodology Committee
- Authorizing Law
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
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)
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)
- Past Opportunities to Provide Input
One of the most common New Year’s resolutions is to live a healthier lifestyle, often with a focus on eating better, exercising more regularly, and losing weight. So we thought we’d do our part in marking this year’s Healthy Weight Week (January 19–23) by spotlighting research funded by PCORI to provide useful information about effective ways to fight obesity.
Obesity is a grave public health threat that affects more than one-third of Americans and ranks behind only tobacco use as a leading cause of preventable death. Obesity is associated with a long list of serious illnesses that take a tremendous toll on individuals, their families, and the nation as a whole. These problems include sleep disorders, diabetes, heart disease, and several types of cancer. So finding better ways to treat obesity is both a personal and public health priority.
Addressing Disparities in Obesity Care
Some groups, including certain racial and ethnic minorities and rural populations, are disproportionately affected by obesity. To address this disparity, PCORI has funded several types of studies.
One study in Massachusetts targets 750 overweight children ages 2–12 from disadvantaged communities. It will test the effectiveness of using health coaches in primary care clinics to improve healthy behaviors and thereby decrease the children’s weights. During the yearlong trial, the health coaches will also inform families about resources in their neighborhoods, such as safe areas to play and places to buy fruits and vegetables.
Another study, in California, will test the relative impact of two ways to teach adults to integrate healthy food portions into their diets. Study participants are 300 low-income, mostly Latino and African-American adults with obesity attending community health centers in Long Beach. In this one-year trial, researchers are comparing the effectiveness of calorie counting versus the choosemyplate.gov approach, which emphasizes filling up on fruits and vegetables.
Through a targeted funding announcement, we recently funded two large studies on obesity treatment. Both trials incorporate a primary care component as well as strong links to community-based partners. Each trial will implement an evidence-based comprehensive lifestyle intervention including reduced-calorie diets, increased physical activity, and behavioral counseling to treat obesity in adults of certain racial and ethnic minorities, with low socio-economic status, or who reside in rural areas.
In both studies, the interventions will be tested against a standard fee-for-service obesity approach that includes behavioral treatment delivered by a primary care team. The goals of the studies are to reduce weight and improve quality of life.
In one of the studies, which will include more than 1,000 patients from racial and ethnic minorities, Louisiana investigators plan to use health coaches embedded in primary care practices. Over two years, the health coaches will deliver a high-intensity lifestyle intervention to help patients meet goals for healthy eating and physical activity. The coaches will adapt their approach to the patient’s health literacy.
The second large study takes place in the rural Midwest. Fourteen hundred patients will be treated over two years in one of three care settings: standard fee for service, disease management, or a patient-centered medical home (PCMH), which provides comprehensive care. The patients in the disease-management setting will receive group behavioral counseling led remotely by obesity specialists. For the PCMH patients, a nurse, registered dietician, or behavioral counselor will provide behavioral counseling for obesity.
Using Health Data to Tackle Obesity
Each of the two large studies described above takes advantage of one of PCORI’s biggest investments—PCORnet, the National Patient-Centered Clinical Research Network. This data infrastructure program is designed to help conduct CER quickly and efficiently.
Because obesity is such a crucial national problem, it was chosen as a focus for all the 11 Clinical Data Research Networks (CDRNs) funded through this initiative. Each will include clinical information on people with weight problems. Since the networks are so large, they will be able to provide data across a wide variety of patient groups, such as rural versus urban, so researchers can assess whether treatment methods affect groups differently. With access to this large dataset, researchers will have the opportunity to look at the impact of many different factors on a diverse set of patient-centered and clinical outcomes.
As a demonstration project to test-drive PCORnet, PCORI may this year fund one or two observational studies addressing aspects of obesity. Such studies compare data from groups receiving different types of care during their normal clinical experience, rather than interventions randomly assigned in an experiment. PCORI’s Board of Governors will consider two topics that arose through our topic-generation process:
- Which types of bariatric surgery result in best outcomes with least risk?
- To what extent does antibiotic use cause excess weight gain in early childhood? At different ages? Different classes? Single drug effects?
Findings from such topics will help patients, clinicians, and other healthcare providers make evidence-based decisions about types of treatments.
Through its investments and resources, PCORI will help to answer important questions patients have about which care options will best help them obtain a healthy weight and improve their quality of life. We are already beginning to determine how best to disseminate such information to patients and others in the healthcare community.
We are keeping a close eye on the obesity studies as they progress and look forward to reporting findings to you as they become available.
What's Happening at PCORI?
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.