Qualification Plan Preparation to Support DDT COA #000069 PROMIS Fatigue Short Form for Individuals with Multiple Sclerosis

In response to RFA-FD-19-028, this project aims to develop a clinical outcome assessment (COA) qualification plan to support the qualification of PROMIS-FatigueMS for limited context of use as a patient-reported outcome (PRO) measure of fatigue among individuals diagnosed with all forms of multiple sclerosis (MS). A letter of intent for the PROMIS-FatigueMS has been approved by the Center for Drug Evaluation and Research (CDER) COA Drug Development Tools (DDT) qualification program under DDT #000069. Specific Tasks: The Department of Medical Social Sciences of Northwestern University Feinberg School of Medicine will serve as a site for this project. Dr. Kaiser will serve as the site Principal Investigator. Our team will be responsible for the following tasks: • Develop a qualification plan according to the CDER COA DDT qualification plan outline. • Develop a quantitative analysis plan, to be included in the qualification plan. The quantitative analysis plan will include: • Proposed cross-sectional analyses to evaluate measurement properties using data from a survey study conducted by Dagmar Amtmann and colleagues at the University of Washington in Seattle • Proposed longitudinal analyses to evaluate measurement properties using data from the study, “Psychometric evaluation of the PROMIS Fatigue and Physical Function measures in people with MS: UK MS Register Study” • We will prepare a draft of the qualification plan, to be reviewed by C-Path, and two subsequent drafts revised based on C-Path feedback • In addition to developing the qualification plan, we will perform the following tasks: • Participate in bi-weekly team conference calls • Oversee input from the study consultant • Maintain the Northwestern project budget