Development and Initial Validation of a New Stent Symptom Questionnaire for Short-Term Dwell Time: The Canadian Endourology Group Stent Symptom Score.

Abstract

We sought to develop and validate the Canadian Endourology Group Stent Symptom Score (CEGSSS), a short and concise Ureteral Stent Symptom Questionnaire to assess the patient-reported impact of ureteral stents in patients with indwelling stents for < 2 weeks. We used a rigorous 3-phase study design: phase 1: Prioritizing domains/items to be included in a minimal needs data set with the help of patient partners and experts. Phase 2: Pilot study of patients with ureteral stents evaluating the feasibility and acceptability of the CEGSSS. Phase 3: Multicentric, North American prospective study evaluating the validity and reliability of the CEGSSS. Phase 1: The first version of the CEGSSS was developed which included 15 items and 3 domains (urinary symptoms, pain, and quality of life). Phase 2: 3 cycles were required to reach data saturation. Patient and expert feedback was incorporated into the final version of the CEGSSS. The final version of the CEGSSS included 11 items and 3 domains. Phase 3: 287 patients were enrolled. Exploratory factor analysis determined that 3 domains were appropriate. All domains and the overall questionnaire showed acceptable to very good internal consistency (Cronbach α between .60 and .81). Test-retest on days 1 and 3 indicated good reliability (intraclass correlation between 0.71 and 0.79), and responsiveness to change and sensitivity to change showed statistically significant differences in total scores for all domains (Wilcoxon signed-rank test, <i>P</i> < .001). This 3-phase development, reliability, and validation study confirms the utility of a new ureteral stent symptoms questionnaire. The CEGSSS is a practical, user-friendly tool that is quicker to complete than the Ureteral Stent Symptom Questionnaire.