Treatment Options for Age-Related Hearing Loss PFA
PCORI seeks to fund clinical comparative effectiveness research (CER) that will generate new evidence to address important decisional dilemmas regarding treatment options for age-related hearing loss. Proposed interventions may include hearing devices and/or support/rehabilitation services that have either documented evidence of efficacy or of widespread use. PCORI encourages rigorous, high-impact studies that evaluate the comparative effectiveness of hearing loss interventions on patient-centered outcomes to inform relevant decisions encountered by patients, their caregivers, and other healthcare stakeholders. Please note that this PFA is soliciting applications across two funding cycles (Cycles 1 and 2 2019).
- Does PCORI fund the cost of interventions including hearing devices?
- Can investigators include the cost of reimbursing patients for their participation in the study?
- Can a clinical partner delivering clinical services in the study be reimbursed for other roles in the study?
- Will PCORI allow investigators to propose the use of newly approved devices such as hearing aids?
- Can an investigator serve as Principal Investigator for an LOI and participate as key personnel (e.g., co-Investigator or subcontractor) on a second LOI for this PFA?
- Can foreign organizations submit an LOI in response to this PFA?
- Are engagement plans included in the LOI?
- Is PCORI interested in multi-site trials?
- Is PCORI seeking to fund observational studies?
- Can investigators use an outcome measure for which a pilot study has been conducted to validate this measure?
- Do investigators have to specify the model of the hearing devices?