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临床试验/NCT05333757
NCT05333757已完成不适用

Assessing the Quality of Life in Adults With Spinal Deformity: a Retrospective Comparison Between Two Questionnaires

Istituto Scientifico Italiano Colonna Vertebrale1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Statistical properties of SRS-22 and ISYQOL questionnaire

研究概览

简要总结

Spinal deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools for this condition have been developed to investigate the extent of this impact, such as the SRS-22 questionnaire and ISYQOL questionnaire.

The latter was initially used for underage patients, but given that some of them continue their therapy and the monitoring beyond the age of 18, we have continued its use in these subjects as well. Given the clinical usefulness and given the lack of questionnaires developed in the Rasch environment for adults, we have extended the application of the ISYQOL questionnaire to the adult population. However, a comparison between the ISYQOL and SRS-22 in adults has not yet been made.

The objective of this study is to verify the validity of ISYQOL and to compare the properties of ISYQOL with those of the SRS-22 questionnaire in adults with spinal deformity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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
  • Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve

排除标准

  • Previous spinal surgery
  • Previous and relevant illnesses, surgery or trauma

结局指标

主要结局

Statistical properties of SRS-22 and ISYQOL questionnaire

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

The Spearman correlation coefficient will be used to evaluate the concurrent validity of ISYQOL questionnaire. Cronbach's alpha will be used to evaluate the internal validity of ISYQOL questionnaire. Rasch analysis will be applied to explore the characteristics of the two tools. In addition, the reproducibility of the measurement. Usually, the goal is to obtain a reliability\> 0.8.

次要结局

未报告次要终点

研究者

发起方
Istituto Scientifico Italiano Colonna Vertebrale
申办方类型
Other
责任方
Sponsor

研究点 (1)

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