跳至主要内容
临床试验/NCT02827331
NCT02827331已完成不适用

Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up

University Hospital, Toulouse0 个研究点目标入组 171,861 人开始时间: 2014年9月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

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