Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain – Cycle 3 2016

Reopened PCORI Funding Announcement (PFA)

Research Initiative Highlights

The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund randomized clinical trials (RCTs) that compare two or more alternative clinical strategies for reducing/eliminating opioid use while managing pain or strategies used to limit dose escalation. As noted in the original funding announcement issued on October 12, 2015, the two priority research questions are:

1. Among patients with chronic noncancer pain on moderate/high-dose long-term opioid therapy, what is the comparative effectiveness of strategies for reducing/eliminating opioid use while managing pain?
2. Among patients with chronic noncancer pain on moderate/low-dose long-term opioid therapy, what are the comparative effectiveness and harms of strategies used to limit dose escalation?

There is a shortage of high-quality evidence demonstrating the safety and effectiveness of long-term opioid therapy for the management of chronic pain, and to date few large-scale studies have assessed strategies for managing and reducing chronic opioid use in a real-world setting. PCORI is interested in studies that include important comorbidities such as mental health disorders, and past or current substance use disorders. Other key subgroup analyses that examine various pain sources or important disparities in the management of long-term opioid therapy are welcome.

Background

PCORI’s mission is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions. Specifically, we fund CER and work that will improve the methods used to conduct such studies. 

PCORI relies on input from multiple stakeholders to set its research priorities. Members of its advisory panels include patients, clinicians, researchers, purchasers, payers, industry, and other healthcare stakeholders. Stakeholders identified the use of long-term opioids for chronic pain as an important topic, which PCORI’s Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options then ranked as a high-priority. PCORI then convened a large multi-stakeholder workshop to provide input on whether specific opioid CER questions could be addressed by PCORI-funded research. Through stakeholder engagement efforts and discussions with PCORI’s Science Oversight Committee (http://www.pcori.org/events/2015/prioritizing-comparative-effectiveness-research-questions-long-term-use-opioids-chronic and http://www.pcori.org/research-results/how-we-select-research-topics/generation-and-prioritization-topics-funding-2), the topic was narrowed to focus on strategies for managing and reducing opioid use. PCORI’s Board of Governors approved this topic on September 28, 2015, for a targeted funding initiative. Through further stakeholder engagement and discussions with PCORI’s Science Oversight Committee, two high priority questions were proposed, and PCORI funded two projects in its funding Cycle 3 2015. The original funding announcement can be found here.

The reissue of this targeted funding announcement reflects the significant policy importance and the crucial need for evidence regarding the comparative effectiveness of different treatment strategies for patients on long-term opioid therapy with chronic noncancer pain.