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临床试验/NCT04909541
NCT04909541招募中不适用

Canadian Endourology Group Stent Symptom Score: Development and Validation of A New Questionnaire

Centre hospitalier de l'Université de Montréal (CHUM)9 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
9
主要终点
Likert scale rating

研究概览

简要总结

Placement of a ureteral stent is a common urological intervention. For decades there was no valid measures available to assess quality of life issues in patients with ureteral stents, which has hampered the understanding of such symptoms and their true impact. In order to improve the outcomes associated with the placement of a stent, a validated tool is needed to measure its impact and the amount of undesirable effects it produces on patients requiring the placement of a stent. In 2003, the team of the Bristol Urological Institute developed a validated questionnaire called the: URETERAL STENT SYMPTOM QUESTIONNAIRE (USSQ). The questionnaire contains 38 items included in 6 sections. Despite the obvious need of a validated questionnaire, the latter remains unused by the community of peer urologists. Many of urologists consider it too long to be used in clinical practice and even for research purposes. This issue motivated the Canadian Endourology Group (CEG) to work collaboratively on the development of the CANADIAN ENDOUROLOGY GROUP STENT SYMPTOM SCORE (CEGSSS) in order to provide clinicians with a more useful and validated tool. To fulfill this objective, the CEG proceeds in three phases. Phase 1. A systematic, deliberative, and participatory approach mostly through face to face meetings, including patients, clinicians, and researchers in the field of Endourology to identify a minimum needs-based set of domains and items that are, clinically relevant to be included in the CEGSSS in order to ensure optimal uptake in the clinical setting. Phase 2. A pilot study to assess feasibility/acceptability and further refine the proposed set of items selected in phase 1 of the study. Phase 3. A multicentric prospective study to evaluate the validity, reliability and sensitivity to change of the CEGSSS.

This research project is conducted by the Canadian Endourology Group (CEG), a panel of experts in the field of endourology in Canada. The CEG is a national member-based organization dedicated to enabling the profession to provide the highest possible standards of endourological care and to advance the science of endourology by collaboratively:

  1. Fostering excellence in endourological practice through advocacy, education, research and practice support tools,
  2. Leading evidence-based clinical practice through the development of practice standards and guidelines in endourology,
  3. Providing continuous professional development for Canadian endourologists along the career-path continuum,
  4. Providing leadership in public education for endourological conditions.

详细描述

This research project is conducted in 3 phases, phase 1 and 2 have been completed and phase 3 is under preparation and will be submitted to the Research Ethics Board soon.

Phase 1: Prioritizing Domains/Items to be included in a minimal needs data set

Objectives:

  1. Identify the Domains/Items to be included in the minimal needs-based data set for assessing symptoms related to stent insertion among those used in the USSS.
  2. Identify other items to include in the CEGSSS.
  3. Reach a final consensus on the Domains/Items to be included in the minimal data set that will constitute the new CEGSSS.

Methodology A systematic deliberative and participatory approach is used to meet the above objectives.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patient with ureteral stent
  • Ability to communicate in English

排除标准

  • Inability to provide an informed consent due to physical or mental inability
  • Active malignancy
  • Obstruction
  • Long-term stent (>2 weeks)

结局指标

主要结局

Likert scale rating

时间窗: through study completion, an average of 1 year

Percentage of agreement on domains and items to be included in the CEGSSS is calculated based on the rating of each item using a Likert scale from 1 to 5. 5 being the highest level of rating regarding the clinical relevance and the necessity of inclusion of a given item

Home made survey about usability and acceptability

时间窗: through study completion, an average of 18 months

Assessment of usability and acceptability of the questionnaire among patients using the CEGSSS survey

Canadian Endourology Group Stent Symptom Score (CEGSSS)

时间窗: At follow-up (7 days after stent placement and before stent removal)

The CEGSSS questionnaire will be administered to participants in order to measure, using the collected data, internal consistency (calculation of Cronbach's α), test retest reliability (calculation of intraclass coefficient), factor loadings, eigenvalues and explained variance of the construct

Ureteral stent symptom questionnaire (USSQ)

时间窗: At follow-up (7 days after stent placement and before stent removal)

The USSQ questionnaire will be administered to participants in order to measure, using the collected data, the correlation between the CEGSSS and the USSQ using Pearson correlation and Spearman rank correlation

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (9)

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