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Kidney Week

Abstract: TH-PO593

Development of a Patient-Reported Outcome for Older Children and Adults with Nephrotic Syndrome as Part of "Preparing a Clinical Outcomes Set for Nephrotic Syndrome" (Prepare-NS)

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Salmon, Eloise, University of Michigan, Ann Arbor, Michigan, United States
  • Sifre, Kayla, 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
  • Nachman, Patrick H., University of Minnesota Twin Cities School of Medicine, Minneapolis, Minnesota, United States
  • Selewski, David T., Medical University of South Carolina, Charleston, South Carolina, 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
  • Peipert, John D., Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Background

Inividuals with nephrotic syndrome (NS) experience fluid overload (FO) which can impact health-related quality of life (HRQOL). In partnership with the Food and Drug Administration (FDA), Prepare-NS aims to create and validate clinical outcome assessments (COAs) of FO in NS for use in drug development.

Methods

Context of use includes the following NS diagnoses: FSGS, minimal change disease, childhood-onset (not biopsied), membranous nephropathy, and IgM nephropathy. Participants with swelling in the past 90 days and not on dialysis volunteered via study website to complete an interview and consent (parental for participants under 18) was obtained. Concept elicitation interviews occurred via Zoom or phone and discussed how NS impacts functioning. Interview transcripts were coded in NVivo by two independent raters according to established standards for qualitative analysis. Recurring themes informed the conceptual model.

Results

To date, 25 participants have completed interviews. Image 1 shows participant demographics. Themes overall were consistent among age, sex, race, and diagnostic subgroups. Image 2 shows the conceptual model.

Conclusion

FO impacts HRQOL in the domains of physical function, fatigue, pain, sleep disturbance, gastrointestinal symptoms, appetite loss, and other essential functions. The next phase of Prepare-NS will be to develop the PRO inclusive of items to assess the impact of FO that is likely to be modifiable in NS disease modifying drug development.

Participant demographics

Health concepts (with representative quotations) elicited during qualitative interviews on the impact of FO in NS

Funding

  • Other U.S. Government Support