Are Primary Outcomes Really Primary? A Questionnaire Survey Study for Exploring Outcomes for Patients With Disc Herniation Reflecting Real Patient Symptoms and Needs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- survey basic characteristics
研究概览
简要总结
Background: The selection of primary outcomes that reflect the real symptoms and conditions of patients is instrumental in clinical studies on the effectiveness of specific treatment modalities. This study aimed to explore the appropriate outcomes that reflect the real-world needs and concerns of patients with lumbar disc herniation (LDH) and provide a basis for designing related clinical trials.
Methods and Findings: This cross-sectional nationwide web-based survey study was conducted in South Korea in November 2022. Patients who were diagnosed with LDH and had LDH-related radiating leg pain were enrolled. The questionnaire consisted of 5 parts: basic characteristics, disease onset, symptom and severity, priority symptoms for improvement, and important factors in treatment. Overall, 500 patients (100 patients from the each age group) were enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed of LDH
- •age 19-69 years
- •presence of LDH-related symptoms such as pain, numbness, weakness, or tingling in the legs
- •agree to informed consent form
排除标准
- •severe mental illness and intellectual disabilities that prevented independence in answering the questionnaire
结局指标
主要结局
survey basic characteristics
时间窗: 1 day
symptom and its severity survey
时间窗: 1 day
disease onset survey
时间窗: 1 day
priority symptoms for improvement survey
时间窗: 1 day
important factors in treatment survey
时间窗: 1 day
次要结局
未报告次要终点