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Past Opportunities to Provide Input
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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
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- 10: Standards for Studies of Diagnostic Tests
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- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
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WASHINGTON, D.C. (July 19, 2016) – The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved nearly $21 million to fund two studies to help determine the most effective ways to manage and reduce opioid use among people with chronic pain. The awards were among 35 totaling $153 million approved today by the Board.
Treatment with opioids is common for persons with chronic pain, but long-term opioid use can have serious side effects, including addiction. Patients, family caregivers, researchers, clinicians, policymakers and others all are interested in addressing such concerns while ensuring that effective pain treatment options are available for those who need them.
"Opioid overuse and misuse is a serious issue. By supporting this research, we’re looking at strategies for more effective pain care that address the areas of greatest concern to those living with chronic pain, such as quality of life and risks and consequences of addiction,” said PCORI Executive Director Joe Selby, MD, MPH. “The research we are supporting will help to inform the decisions that clinicians and patients make about the use of opioids.”
The Board approved a $12.5 million award for a research team based at the University of Minnesota to conduct a study focusing on veterans with chronic pain. The project will compare two approaches to pain management that differ in resource intensity. In one approach, a pharmacist and supervising physician will collaborate to determine the best medication plan for each patient and provide care through telemedicine. In the other, veterans will receive care that encourages integrative pain management options, such as exercise, in addition to medication from an integrated team that includes a physician, psychologist, and physical therapist. The trial will also examine the effectiveness of approaches for tapering the medications, including the use of buprenorphine among those taking high doses of opioids.
A research team based at the University of Wisconsin was approved for an $8.5 million award to conduct a study focused on people using opioids to treat chronic low back pain. Many patients, their families, and clinicians are interested in using alternative treatments, such as mindfulness meditation and cognitive behavioral therapy. The trial will compare the effectiveness of these two alternative treatments for low back pain management.
Each study involves advocacy organizations, major professional societies and associations, payers, and other key patient and stakeholder groups in the research design and implementation. Some of the partners include Veterans Affairs leadership as well as veteran and nonveteran stakeholders. This kind of engagement can help ensure that the outcomes studied are ones that matter most to patients and those who care for them and can facilitate quicker dissemination and application of study results.
There are an estimated 78 opioid-related deaths a day in the United States — more than 28,000 per year, according to the American Medical Association. Treatment with opioid pain medications is common for severe pain, but research shows these medications may not always help and can cause serious health issues, especially when taken at high doses.
The new studies seek to address evidence gaps and answer questions that people with chronic pain and other healthcare stakeholders identified as their top priorities through PCORI’s process for topic selection. A multi-stakeholder workshop in June 2015 brought together patients and participants representing groups advancing research on chronic pain as well as clinicians, government agencies, industry, and health insurance plans to refine the questions that became the focus of PCORI’s funding announcement.
All awards are approved pending completion of a business and programmatic review by PCORI staff and completion of a formal award contract.
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 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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