Abstract: SA-PO0770
Refinement of NS-SIM-PRO and NS-SIM-ObsRO by Cognitive Debriefing for Use in Validation Study of Clinical Outcome Assessment Set (COA) for Nephrotic Syndrome (Prepare-NS)
Session Information
- Glomerular Research: Design, Registries, Surveys, and Epidemiology
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Salmon, Eloise, University of Michigan, Ann Arbor, Michigan, United States
- Hashemi, Somayeh, University of Michigan, Ann Arbor, Michigan, United States
- Rahimi, Ashley E., University of Michigan, Ann Arbor, Michigan, United States
- Scherr, Rebecca, University of Michigan, Ann Arbor, Michigan, United States
- Zhai, Yan, University of Michigan, Ann Arbor, Michigan, United States
- Carlozzi, Noelle E., University of Michigan, Ann Arbor, Michigan, United States
- Lai, Jin-Shei, Northwestern University, Evanston, Illinois, United States
- Hurt, Courtney N., Northwestern University, Evanston, Illinois, United States
- Kuharic, Maja, Northwestern University, Evanston, Illinois, United States
- Peipert, John D., Northwestern University, Evanston, Illinois, United States
Background
Fluid overload (FO) in nephrotic syndrome (NS) impacts health-related quality of life. In partnership with Food and Drug Administration, Prepare-NS aims to create and validate a COA of FO in NS for use in drug trials over the lifespan. Prior study phases included gap analysis and concept elicitation interviews, resulting in draft swelling impact measures (SIMs) refined here by cognitive debriefing.
Methods
Participants representative of trial populations in NS were recruited through clinical sites and patient advocacy groups. Semi-structured interviews were conducted; items and interview guides modified iteratively as feedback collected. Focus areas included item interpretation, relevance, recall period, comprehensiveness, and meaningful change.
Results
23 impacted individuals and 14 caregivers of young children with NS interviewed with demographics in Figure 1. High comprehensibility (PRO 98%, ObsRO 100%) reported; item relevance varied by swelling severity. Modifications to SIMs based on participant feedback outlined in Figure 2.
Conclusion
NS-SIM-PRO and NS-SIM-ObsRO now will move forward into a validation study where individuals (or caregivers of young children) with NS and current swelling will complete surveys at enrollment, 3 months, and 9 months to establish psychometric properties of the SIMs.
Funding
- Other U.S. Government Support