短期間留置の新規ステント症状質問票の開発と初期検証：カナダ泌尿器科グループステント症状スコア（CEGSSS）

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 <2weeks.

We utilized a rigorous 3-phase study design: Phase 1 (P1): Prioritizing domains/items to be included in a minimal needs data set with the help of patient partners and experts. Phase 2 (P2): Pilot study of patients with ureteral stents evaluating the feasibility and acceptability of the CEGSSS. Phase 3 (P3): Multicentric, North American prospective study evaluating the validity and reliability of the CEGSSS.

P1: The first version of the CEGSSS was developed which included 15 items and 3 domains (urinary symptoms, pain, and quality of life). P2: 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. P3: 287 patients were enrolled. Exploratory factor analysis determined that 3 domains was appropriate. All domains and the overall questionnaire showed acceptable to very good internal consistency (Cronbach's α between 0.60 and 0.81). Test-retest on day 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, p<0.001).

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 USSQ.