Cycle 2 2021 Funding Cycle PCORI Funding Announcements: Addressing Disparities; Assessment of Prevention,

In addition to risk assessment and management related to the planning and conduct of the research itself, applicants should also consider provisions in their leadership and staffing plan to assure study continuity in the event of personnel absences due to quarantine, illness, or the provision of clinical care. [...] The reauthorizing language clarifies that, in addition to the relevant health outcomes and clinical effectiveness, relevant outcomes included within PCORI-funded projects may include the potential cost burdens and economic impacts of the utilization of medical treatments, items, and services when relevant to patients and caregivers or to other stakeholders. [...] Examples include, but are not limited to, the following: • Background to the research question or feasibility of study • Document the importance of the research question • Estimating the size of the potentially eligible population • Determining the range of current treatment practices and sequencing • Assessing the duration of continuous treatment and care Studies in Rare Diseases PCORI is interes. [...] However, the burden is on the applicant to justify the study’s importance in the absence of diversity; to discuss which subgroups are most important; and to discuss how the subgroups will be analyzed, including whether or not the study will be powered to examine the question of effectiveness in subgroups. [...] Implementation research also includes the study of discontinuation of interventions that have been found to be ineffective.13 The intent of dissemination and implementation research is to understand how best to spread and sustain knowledge and the associated evidence-based interventions, as well as how and why health information may or may not reach different groups of patients and stakeholders.