Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171,861
- 主要终点
- Comparison of mortality from all causes in the 3 groups as assessed by clinical data collected
研究概览
简要总结
The question of the inclusion of periods of interruptions and periods unobservable has been studied as part of medico-administrative databases. However, the specificity of the health insurance databases justify the realization of dedicated methodological research. A thorough knowledge of the purpose of these data, how they collect and restitution is an essential prerequisite to carry out this work.
One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis of the comparison between the exposure groups. However, this traditional approach has the major drawback of neglecting the changing nature of drug exposure, and therefore fails to take into account any changes or interruptions doses. Approaches to take into account the time dependent variables were developed. These allow to take into account any interruptions. However, as part of study on health databases, sometimes we do not have the status in relation to the exhibition on the entire monitoring period. This is for example the case during hospitalization. The bias generated by the failure to take account of these periods ("non measurable time bias") can be problematic when a long exposure and chronic disorders require hospitalization.
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
- 否
入选标准
- •Beneficiaries of all social security regimen with a minimum of one year of data in general sample of beneficiaries
- •Group expose to benzodiazepine :
- •Exposition to at least one benzodiazepine or anxiolytic
- •Group antidepressants and anxiolytics and hypnotics non benzodiazepines :
- •Exposition to at least one antidepressants and anxiolytics and hypnotics non benzodiazepines
- •Control group :
- •Patient having a medical consultation without prescription of interest
排除标准
- •Non incident patient : Patient having a prescription of benzodiazepines, clonazepam, tetrazepam, antidepressants, anxiolytics ou hypnotics non benzodiazepine during the last 12 months before index date
结局指标
主要结局
Comparison of mortality from all causes in the 3 groups as assessed by clinical data collected
时间窗: through the end of study (12 months)
Four approaches will be used : * intergroup comparison * Time influence with cox model * Use of markovian models * Inclusion of "non observable periods" with inobservable and observable death models
次要结局
未报告次要终点
