NCT03999489已完成不适用
Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 708 人开始时间: 2015年1月1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
- 708
- 试验地点
- 1
- 主要终点
- Level of utility measured by the SF-6D
研究概览
简要总结
The general main objective of our study is to investigate the psychometric properties, the levels and determinants of the extent of SF- 6D utility in patients followed for recent back pain inflammatory disease.
The specific objectives are :
- Study the feasibility of the tool considering missing data, distribution, construct validity, reproducibility, sensitivity to change or clinically different groups (discriminative ability) the extent of SF -6D utility .
- Study the impact of socio-demographic characteristics, disease characteristics and quality of life, comorbidities at baseline on the measurement of utility and sensitivity to change.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient should be given free and informed consent and signed the consent
- •The patient must be affiliated or beneficiary of a health insurance plan
- •patients aged 18 years and under 50
- •inflammatory back pain (buttocks , lumbar or thoracic spine )
- •fulfilling the criteria of Calin or Berlin (30,31)
- •duration of symptoms than three months and less than three years
- •symptoms suggestive of spondyloarthritis as assessed by the local investigator ( score≥5 on a numerical scale from 0 to 10 where 0 = no evocative and 10 = very suggestive of spondyloarthritis ) .
排除标准
- •Another clearly defined spinal disease (eg discarthrose )
- •history of treatment with biotherapy
- •taking glucocorticoids allowed only in low dose of less than 10mg of prednisone daily and stable for at least four weeks before inclusion
- •Current or history anomalies that could interfere with the validity of informed consent and / or prevent a patient's optimal adhesion to the cohort (eg , alcoholism , mental illness) .
结局指标
主要结局
Level of utility measured by the SF-6D
时间窗: 12 months
The SF-6D derives from 11 questions of the SF36 using the algorithm of Brazier et al which then provides a unique score. It has 6 dimensions: Physical Function, Role Limitation, Social Function, Pain, Mental Health and Vitality with 4 to 6 levels of responses depending on the dimension. SF-6D thus makes it possible to describe 18,000 health conditions. The utility score obtained with SF-6D varies between 0.29 and 1.
次要结局
未报告次要终点
研究者
研究点 (1)
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