The Extended Salford Lung Study ("Ex-SLS") Data Access Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,183
- 试验地点
- 2
- 主要终点
- Retrospective EMR data
研究概览
简要总结
The Salford Lung Study (SLS) subjects represent a group of COPD and asthma patients whose disease is extremely well-characterised over a short time period. Subjects in the SLS originally consented for information relevant to the study to be shared with the sponsor (GSK). These data were limited to three years prior to randomisation and the twelve-month interventional treatment period. Broadened access to patients' data would allow SLS subjects' entire disease journey to be researched, presenting a rare opportunity to improve scientific and clinical understanding of COPD/asthma disease risk, treatment and progression. This proposal seeks to collect additional subject-level data from SLS patients via their electronic medical records (encompassing past and future data for up to 10 years from the date of consent) and via a one-off patient questionnaire administered at the time of consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who were randomized to treatment in the original SLS studies
- •Subjects who are able to, and choose to, provide written consent for the additional information to be collected.
排除标准
- •Subjects who were lost to follow-up/moved away, withdrew consent or died during or subsequent to the original SLS studies.
- •Subjects considered (at the discretion of the investigator) as too ill to participate or without the mental capacity to provide informed consent.
研究组 & 干预措施
Chronic obstructive pulmonary disease
Subjects with COPD who were randomised to treatment in the original SLS
Asthma
Subjects with asthma who were randomised to treatment in the original SLS.
结局指标
主要结局
Retrospective EMR data
时间窗: Up to 10 years
All historical data from consent until the beginning of patients' electronic health records, encompassing all routinely-available electronic demographic and health-related data back to a patients' earliest available electronic record.
Risk factor questionnaire
时间窗: Up to 10 years
Historical demographic, COPD/asthma risk factor information and clinical data not routinely available. Collected via paper questionnaire.
Prospective EMR data
时间窗: Up to 10 years
Prospective longitudinal data, encompassing collection of future routinely-recorded electronic demographic and health-related data for a period of ten years from this consent or until a patient is either lost to follow up or at the time of their death.
次要结局
未报告次要终点