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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
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WASHINGTON, D.C. (June 14, 2013) – The Patient-Centered Outcomes Research Institute (PCORI) today announced an agreement with the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), to form a partnership to fund a major intervention study aimed at preventing injuries from falls in older adults.
The memorandum of understanding supports the formation of the “Falls Injuries Prevention Partnership,” which establishes the basis for an NIA-PCORI funding announcement for a large-scale, multi-year clinical trial on preventing injuries due to falls in non-institutionalized older individuals. PCORI plans to commit up to $30 million to this effort; the final amount is yet to be determined.
The intent of this collaborative project is to evaluate a comprehensive, multi-factorial approach to preventing a frequent and often debilitating type of injury among the fast-growing population of older adults. There is extensive evidence that older people who have previously fallen have a significant risk of falling again. Patients, caregivers, and clinicians all want to know the best way to address this problem, but there is uncertainty about the best prevention strategy.
The planned study will actively involve older patients, healthcare professionals who care for these individuals, family caregivers, and other stakeholders in designing and conducting the study and disseminating the results. Such an approach is central to PCORI's mission to advance comparative effectiveness research (CER). The collaboration will take advantage of NIA's expertise in conditions affecting older individuals as well as its established infrastructure and capabilities in managing large, multi-year clinical trials.
“This agreement between PCORI and the NIA will launch a partnership that combines the strengths of both of our organizations in an effort to provide answers about a problem that affects millions of patients, family members, caregivers, clinicians and others,” said PCORI Executive Director Joe Selby, MD, MPH. “It also provides a template for future collaborations with NIH and other funders to conduct comparative effectiveness studies that focus on the needs, concerns and questions most important to patients.”
"Injuries from falls are a major cause of loss of independence for older people. This is a significant public health problem,” said NIA Director Richard J. Hodes, MD. “The partnership with PCORI brings the clinical and patient communities together with experts in biomedical research, which will enable us to develop and support a large clinical trial with outcomes that can be translated and implemented in a real-world setting.”
NIA is in the process of developing a Funding Opportunity Announcement (FOA) that will contain the parameters and details of the intended study. The FOA is expected to be finalized in late July; further details will be available at that time. NIA has issued a Request for Information to gather insights from individual stakeholders and organizations involved in the care and well-being of older individuals.
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 healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.
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.
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