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Kidney Week

ASN / Education & Meetings / Kidney Week /
Abstract: TH-PO632

Qualitative Findings for Preparing a Clinical Outcomes Assessment Set (COA) for Nephrotic Syndrome (Prepare-NS)

Session Information

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
  • Creguer, Tina, University of Michigan, Ann Arbor, Michigan, United States
  • Hurt, Courtney N., Northwestern University Feinberg School of Medicine, Chicago, Illinois, 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 Feinberg School of Medicine, Chicago, Illinois, United States
  • Wadhwani, Shikha, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
  • Peipert, John D., Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Background

Fluid overload (FO) in nephrotic syndrome (NS) impacts health-related quality of life (HRQOL). Partnering with Food and Drug Administration (FDA), Prepare-NS aims to create and validate COA of FO in NS for use in drug trials over the lifespan. Prepare-NS has developed and debriefed survey items capturing key aspects of FO and its impact on function.

Methods

Individuals with (or caregivers of young children with) focal segmental glomerulosclerosis, minimal change disease, IgM nephropathy, membranous nephropathy, or childhood-onset NS (no biopsy) who had NS edema within 3 months volunteered for interviews on study website. Concept elicitation (CE) by Zoom or phone discussed how FO impacts functioning and other symptoms. Transcripts were coded in NVivo by two independent raters. Recurring themes informed conceptual model development and draft survey items. Additional participants provided feedback on draft items by cognitive debriefing (CogDe).

Results

32 individuals with NS and 26 caregivers of children with NS completed CE. 6 CogDe interviews analyzed to date. Figure 1 shows demographics. CE themes overall consistent across the lifespan, and among sex, race, and diagnosis groups. Figure 2 shows quotations from CE (by conceptual model domain) and CogDe.

Conclusion

FO in NS over the lifespan impacts multiple HRQOL domains. Validation of survey instruments as COAs in a larger quantitative study is the next phase of Prepare-NS.

Funding

  • Other U.S. Government Support