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Comprehensive Qualitative Assessment of Urethral Stricture Disease: Toward the Development of a Patient Centered Outcome Measure

Benjamin N. Breyer, Todd C. Edwards, Donald L. Patrick, Bryan B. Voelzke
DOI: http://dx.doi.org/10.1016/j.juro.2017.05.077

The primary objective of this study was to report what patients considered to be the most important symptoms, functions and impacts of urethral stricture disease. Patient and physician perspectives were correlated.

Materials and Methods
Patients were involved at each step of patient reported outcome measure development. We performed 1) qualitative semistructured concept elicitation interviews, 2) cognitive interviews, 3) prioritization interviews and 4) item prioritization by patients in regard to bother. A total of 22 reconstructive urologists ranked the items in regard to making treatment decisions.

Patient qualitative interviews were done until no new information was gained (16 interviews) to reach concept saturation. A total of 40 items were generated from interview data. Urinary items predominated over sexually related content (34 vs 6). A review of published patient reported outcome measures revealed 10 legacy items that were not derived from the qualitative interviews. Two iterative rounds of cognitive interviews were performed in a separate cohort of 5 and 4 patients, respectively, to assess patient comprehension. Item prioritization was done in a separate cohort of 20 patients. The final instrument for validation included 31 items, of which 27 were new and 4 were legacy items. For the top 15 ranked items there was 53% agreement between patients and physicians. Patients were most worried about inability to urinate and urinary dribbling.

We found multiple patient generated concepts related to urinary and sexual impact, function and symptoms. Patients and clinicians had a low agreement rate regarding item importance.

Key Words: urethral stricture, patient reported outcome measures, urologists, treatment outcome, urination disorders

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