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Abstract: TH-PO1047

Development of a Clinician-Reported Outcome Measure for Edema Assessment

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Carlozzi, Noelle E., University of Michigan, Ann Arbor, Michigan, United States
  • Trachtman, Howard, NYU Langone Health, New York, New York, United States
  • Walsh, Liron, Goldfinch Bio, Boston, Massachusetts, United States
  • Lynam, Chris, Goldfinch Bio, Boston, Massachusetts, United States
  • Gipson, Debbie S., University of Michigan Mott Children's Hospital, Ann Arbor, Michigan, United States
Background

Patients report edema is a high impact manifestation of proteinuric kidney disease. However, evaluation of edema is not standardized and can manifest as localized or generalized swelling. Accurate and valid assessment of edema is important for patient care and clinical trials of patients with proteinuric kidney disease. The objective of this study was to develop a clinician reported outcome measure (ClinRO) for edema assessment for use with patients with glomerular disease.

Methods

Semi-structured interviews were conducted with pediatric and internal medicine nephrology clinicians (physicians and advanced practice providers) to elicit physical exam findings of edema manifestations, documentation, and importance. Concepts were derived from these interviews, confirmed with clinicians and then used to create the Edema ClinRo.

Results

14 clinicians participated in the study, including 7 pediatric and 7 internal medicine experts. Concepts identified included assessment of body regions (periorbital, extremities, trunk and if patient endorsed genitals) and severity rating.
The ClinRO was generated (Figure) in an iterative fashion with input from clinician stakeholders. Online training and certification modules were developed for use and a user acceptance testing step was implemented

Conclusion

The Edema ClinRO was developed based upon pediatric and internal medicine clinician input using best practice methods to support implementation of standardized edema assessment in clinical and research contexts. User acceptance testing of the ClinRO has been completed and for the training module is underway. With web-based Edema ClinRo dissemination and data collection, the utility of this measure will be assessed as a future step.

Figure. Edema Clinician Reported Outcome Measure

Funding

  • Commercial Support