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.

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.

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.

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