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Past Opportunities to Provide Input
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- 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
WASHINGTON, D.C. (Oct. 23, 2013) – The Patient-Centered Outcomes Research Institute (PCORI) and the Agency for Healthcare Research and Quality (AHRQ) have partnered on the release of a Request for Applications (RFA) for research designed to evaluate the effectiveness of different treatment strategies for uterine fibroids and to better understand patient preference in informing treatment decisions.
In partnership with AHRQ, PCORI will commit up to $20 million to develop a geographically diverse registry of women who have been treated for uterine fibroids and fund studies of the comparative effectiveness of medical and surgical therapies using data from this registry. AHRQ will administer the application process to identify an awardee who will receive up to $4 million per year for up to five years to build the registry and conduct the research.
Uterine fibroids are noncancerous growths in the uterus that affect up to 10 percent of women of childbearing age. Although they often occur without symptoms, they can lead to significant pain, bleeding, and fertility problems. In 2007, more than 260,000 women with uterine fibroids underwent hysterectomies.
Because there is little evidence about the relative effectiveness of the therapies used to manage symptoms and address patients’ preferences for reproductive options, women and their clinicians often face significant uncertainties in deciding on a course of treatment. PCORI and AHRQ agreed earlier this year to collaborate on research to address these uncertainties and answer patients’ questions about potential implications for their ability to bear children as well as other risks and benefits.
“This initiative, which will generate critical information about the comparative benefits and risks of the medical and surgical options used to treat uterine fibroids, is an excellent illustration of the kind of patient-centered comparative effectiveness research that PCORI funds,” said PCORI Executive Director Joe Selby, MD, MPH. “We are excited to work with our colleagues at AHRQ to produce new evidence that will help women, their families, and their healthcare providers make better-informed choices.”
The RFA calls for development of a large, multi-center, practice-based registry of women who have been treated for uterine fibroids. The registry must be geographically broad to ensure the inclusion of women from diverse backgrounds as well as those who traditionally have been less involved in health research. The collection of privacy-protected, real-world information on women’s experiences with different treatments will allow the conduct of a range of studies comparing patient-centered clinical outcomes.
Letters of intent may be submitted to AHRQ by Friday, Nov. 15 and applications are due Monday, Dec. 16. The due dates are not affected by the federal government shutdown. Eligibility requirements, application criteria, informational contacts at AHRQ, and other details are provided in the RFA.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.
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