During the Research Phase, NUCOAT researchers will develop and validate physical function “performance outcome” and “patient reported outcome” assessments.
During the research phase we will:
- Continue to research sarcopenia in older adults and three rare disorders in further detail
- Conduct in-depth patient interviews for analysis on physical function impacts
- Test a draft Clinical Outcome Assessment in a cognitive interview study, which will eventually be tested against current, standard assessments
- Consult expert panels (the Stakeholder Engagement Group and Clinical Expert Panel) for input on development and validation of physical function assessments
- Validate the measures and physical function assessments through the collection of data from in-person and remote study visits
- Conduct detailed psychometric analysis of the validation data
- Use results of Validation Study to identify meaningful measures of PF that would likely qualify as approvable clinical outcome assessments (COAs) in the FDA Drug Development Tool (DDT) Qualification Program
Once the assessments are finalized, the NUCOAT team will work with the United States Food and Drug Administration (FDA) to distribute the assessments to interested groups of patients, care partners, industry professionals, and policy makers.. The assessments and information about the assessments will be available through HealthMeasures.net.