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Past Opportunities to Provide Input
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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
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- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
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- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
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- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
WASHINGTON, D.C. (July 17, 2013) – As the next step in a partnership with the Patient-Centered Outcomes Research Institute (PCORI), the National Institute on Aging, part of the National Institutes of Health, today issued a Request for Applications (RFA) for a large-scale, multi-pronged clinical trial on prevention of fall-related injuries in non-institutionalized older adults. PCORI will commit up to $30 million to fund the trial selected through the application and peer-review process that NIA will administer.
The RFA arose from an agreement by the two institutes announced in June to form the “Falls Injuries Prevention Partnership,” which focuses on a common, serious health concern for older individuals, their families, and their clinicians. Falls frequently result in serious injuries that can lead to loss of function and independence. Older people who have previously suffered a fall have a significant risk of falling again. Patients, caregivers, and clinicians all want to know the best ways to address this problem, but there is uncertainty about the best prevention strategies.
As detailed in the RFA, applications must describe a clinical trial that will assess a multifactorial strategy for fall-related injury prevention that will include identification of high-risk individuals, assessment of their specific risk factors, and selection and assessment of interventions that address these factors.
Applications also must spell out how they will actively involve patients, family caregivers, healthcare professionals, and other stakeholders in the design and conduct of the trial and sharing of its results. These criteria fulfill PCORI’s mission of supporting research guided by those who need and will be most directly affected by study results.
Prospective applicants can find full details of the criteria, submission policies, and instructions in the RFA available on the NIH Guide for Grants and Contracts. Proposals are due Wednesday, Nov. 13.
The question of what strategies or combination of strategies work best for patients with specific risk factors for fall-related injuries rose to a priority level for PCORI based on extensive input the institute received from patients, caregivers, healthcare providers, payers, and other stakeholders, noted PCORI Executive Director Joe Selby, MD, MPH.
“The Falls Injuries Prevention Partnership combines the strengths of both institutes,” Selby said. “We’re pleased to have the benefit of NIA’s extensive expertise in conditions affecting older individuals as well as its established infrastructure and capabilities in managing large, multi-year clinical trials in this effort to facilitate patient-centered research on a serious problem that affects millions of older individuals and their families.”
“Serious injuries from falls, such as broken bones or traumatic brain injury, are a major reason for the loss of independence among older people,” said NIA Director Richard J. Hodes, MD. “This is a significant public health problem, greatly affecting older adults and their families as well as the healthcare system. The clinical trial envisioned here seeks to test a comprehensive and practical approach that can make real progress in reducing these injuries.”
The Falls Injuries Prevention Partnership is among the first initiatives to result from PCORI’s effort to craft funding announcements focused on specific, high-impact research topics. PCORI identified an initial set of these topics by reviewing previous efforts to identify and prioritize gaps in comparative effectiveness research and then empaneling expert, multi-stakeholder workgroups to help refine the list.
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 health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.
The NIA leads the federal government effort conducting and supporting research on aging and the health and well-being of older people. The Institute’s broad scientific program seeks to understand the nature of aging and to extend the healthy, active years of life. For more information on research, aging, and health, go to www.nia.nih.gov.
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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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