Development of a Patient-reported Outcome Measure for Patients With Ureteral Stricture Disease

Devin Boehm; Kyle Nolla; Aurash Naser-Tavakolian; Jonathan Rosenfeld; Emily Ji; James W Griffith; Ziho Lee

doi:10.1016/j.urology.2024.10.054

Development of a Patient-reported Outcome Measure for Patients With Ureteral Stricture Disease

Urology. 2024 Oct 24:S0090-4295(24)00941-5. doi: 10.1016/j.urology.2024.10.054. Online ahead of print.

Authors

Devin Boehm¹, Kyle Nolla², Aurash Naser-Tavakolian¹, Jonathan Rosenfeld¹, Emily Ji¹, James W Griffith³, Ziho Lee⁴

Affiliations

¹ Department of Urology, Northwestern University, Feinberg School of Medicine, Chicago, IL.
² Department of Psychology, Morgan State University, Baltimore, MD.
³ Department of Obstetrics and Gynecology, University of Chicago, Medicine & Biological Sciences, Chicago, IL.
⁴ Department of Urology, Northwestern University, Feinberg School of Medicine, Chicago, IL. Electronic address: Ziho.Lee@nm.org.

PMID: 39461428
DOI: 10.1016/j.urology.2024.10.054

Abstract

Objective: To develop a patient-reported outcome measure (PROM) using qualitative patient-centered methods and expert opinion to quantify the impact of ureteral stricture disease (USD) and its management.

Methods: Patients undergoing robotic ureteral reconstruction for USD between 9/2021-4/2023 were enrolled. A novel patient-reported outcome was developed in four steps: (1) Semistructured concept elicitation interviews to evaluate the physical, mental, and social effects of USD; (2) Item generation based on themes identified in the interview transcripts, existing patient-reported outcomes on health-related Quality of Life, and expert opinion; (3) Feedback on the generated items from a panel of external clinicians with high surgical volume for USD; and (4) Cognitive interviews assessing patient comprehension and relevance.

Results: We conducted 14 semistructured concept-elicitation interviews. After qualitative analysis of these interviews, we generated a 13-item instrument: 8 items assessed symptoms, 4 items assessed Quality of Life, and 1 item assessed patient-perceived treatment success. Expert input supported the content of the PROM and guided minor adjustments. Two rounds of cognitive interviews were conducted. The first round included 6 patients, and the PROM was revised according to patient feedback. The second round included 4 patients, and no additional revisions were made based on the second round.

Conclusion: We utilized qualitative patient-centered methods and expert opinion to develop a PROM to assess outcomes in patients undergoing surgery for USD.