Notice of Upcoming PCORI Funding Announcement (PFA)

This notice provides information about an upcoming Patient-Centered Outcomes Research Institute (PCORI) funding announcement (PFA), which will be released by PCORI on June 1, 2018. PCORI seeks to fund multiple high-quality clinical studies that compare the effectiveness of evidence-based treatments for relief of common symptoms experienced by patients with serious, advanced illness. For the Cycle 2 2018 PFA, PCORI has refined the requirements for choosing comparative treatments, and removed depression from the symptom list.

Prior research on symptom management has shown the potential for clinically significant improvements in quality of life, symptom burden, utilization of hospital services, and caregiver stress. Additional evidence from head-to-head studies is needed to improve the evidence base about benefits and harms of various symptom management approaches. The goal of this funding initiative is to support patient- and caregiver-centered, comparative clinical effectiveness research to generate important findings that will aid decision making about symptom management in advanced illness.

Symptoms of specific interest for this PFA include pain, fatigue, dyspnea, insomnia, anorexia/cachexia, nausea/vomiting, and anxiety. Study populations should include patients with a serious, life-limiting diagnosis, including but not limited to advanced heart failure, cancer, chronic obstructive pulmonary disease, end-stage liver and kidney disease, or neurodegenerative diseases. PCORI is particularly interested in studies that will increase the evidence for treatments that are effective in pediatric and adolescent populations, where fewer studies have been completed.

For this PFA, the proposed interventions should include the most relevant treatment choices currently available to patients with the symptoms and conditions proposed. These interventions may include pharmacological or nonpharmacological treatments. The proposed interventions must have proven efficacy (from systematic reviews, prior empirical investigations, or other scientific documentation) or documentation of widespread use in the population proposed. Study outcomes should include well-validated patient assessment measures (e.g., quality of life), symptom measures, adverse events, and caregiver measures (e.g., burden) as appropriate. PCORI is particularly interested in those studies that propose long-term follow-up; therefore, applicants should include a minimum of six months of follow-up for patient participants.

This PFA preannouncement is provided to allow potential applicants additional time to identify collaborators, obtain stakeholder input on the research question and design, and develop responsive, high-quality application proposals.