跳至主要内容
临床试验/NCT02688504
NCT02688504已完成不适用

CESIR-U2 : Influence of Drugs Use and Health Status

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2016年10月18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
1,200
试验地点
2
主要终点
Drugs use reported by drivers involved in road accidents

研究概览

简要总结

In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization < 24 hours) that represent around 73% of accidents.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • •Driver involved in a road accident and admitted in an emergency department
  • •Aged over 18 years
  • •Able to respond to a structured questionnaire
  • •Having agreed to participate in the study

排除标准

  • •Passenger
  • •Pedestrian
  • •Discharge or transfer to another hospital/clinic before the interview

结局指标

主要结局

Drugs use reported by drivers involved in road accidents

时间窗: inclusion date

Drugs use is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who take drugs, by ATC classification, by pictogram and by drug.

次要结局

  • Seriousness of the accident(inclusion date)
  • Knowledge of drivers about graded pictogram featured on drugs packaging(inclusion date)
  • Responsibility of the driver for the accident(inclusion date)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验