To develop a patient-reported outcome measure using qualitative patient-centered methods and expert opinion to quantify the impact of ureteral stricture disease and its management. Patients undergoing robotic ureteral reconstruction for ureteral stricture disease between 9/2021-4/2023 were enrolled. A novel patient-reported outcome was developed in four steps: 1) Semi-structured concept elicitation interviews to evaluate the physical, mental, and social effects of ureteral stricture disease; 2) Item generation based on themes identified in the interview transcripts, existing patient-reported outcomes on health-related QOL, and expert opinion; 3) Feedback on the generated items from a panel of external clinicians with high surgical volume for ureteral stricture disease; and 4) Cognitive interviews assessing patient comprehension and relevance. We conducted 14 semi-structured concept-elicitation interviews. After qualitative analysis of these interviews, we generated a 13-item instrument: 8 items assessed symptoms, 4 items assessed QOL, and 1 item assessed patient-perceived treatment success. Expert input supported the content of the patient-reported outcome measure and guided minor adjustments. Two rounds of cognitive interviews were conducted. The first round included 6 patients, and the patient-reported outcome measure 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 patient reported outcome measure to assess outcomes in patients undergoing surgery for ureteral stricture disease.
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