WASHINGTON -- The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $9 million to fund a new study comparing two approaches to relieving noncancer chronic pain and reducing opioid use.
The study will assess which approach most effectively leads to lower or discontinued opioid use and greater pain relief among people who have been using opioids over the long term. Half the patients will receive specific behavioral therapies, including cognitive behavioral therapy for chronic pain and a technique called motivational interviewing. The other half will receive individualized therapy plans based on a shared decision making approach in which patients and their clinicians together discuss the risks and benefits of therapeutic options and the patients' preferences and values.
"People living with pain, family caregivers, clinicians, policy makers and others are interested in finding the most effective ways to alleviate chronic pain, a very real problem, while also minimizing or avoiding the harms that can come with long-term use of opioids," said PCORI Executive Director Joe Selby, MD, MPH. "By supporting this research, we're looking at strategies for 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."
With this new award, PCORI has invested more than $71 million in 12 comparative clinical effectiveness research (CER) studies related to opioid use as part of a total portfolio of about $209 million supporting dozens of CER studies related to noncancer pain management and opioid use.
The newly funded study will tap into the data resources of the Mid-South Clinical Data Research Network, a partner network of PCORnet. PCORnet is a PCORI-funded initiative to create a national patient-centered network for conducting clinical research more efficiently by harnessing the power of patient data and input from patients and other healthcare decision makers.
The board also gave PCORI approval to post five new PCORI Methodology Standards for public comment. The PCORI Methodology Standards provide minimal requirements for the conduct of scientifically valid patient-centered outcomes research (PCOR). They address study design, analytic methods, and other best practices for PCOR.
Four of these new standards focus on studies of complex interventions, a broad category of multicomponent interventions. The fifth new standard addresses the essential elements of a data management plan, which is key to ensuring data integrity when conducting PCOR. PCORI will accept public comments through a form on its website through Friday, Dec. 29.
If adopted by the PCORI Board of Governors following response to public comment, these new standards would join 48 methodology standards that have been created or endorsed by PCORI's Methodology Committee.
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About PCORI
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.