Health and Road Safety: Influence of Drugs Use and Health Status (CESIR-U2)
CESIR-U2 : Influence of Drugs Use and Health Status
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.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
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Bordeaux、法国、33000
- Hôpital Pellegrin
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Périgueux、法国
- CH de Périgueux
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Minors
- Passenger
- Pedestrian
- Discharge or transfer to another hospital/clinic before the interview
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
队列和干预
团体/队列 |
|---|
|
serious road accidents
Drivers involved in serious road accidents (hospitalization > 24 hours)
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non-serious road accidents
drivers involved in non-serious road accidents (hospitalization < 24 hours).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Drugs use reported by drivers involved in road accidents
大体时间:inclusion date
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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.
|
inclusion date
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Responsibility of the driver for the accident
大体时间:inclusion date
|
The responsibility of the driver (responsible or not responsible) is a data extracted from the BAAC sheet (a sheet fulfilled by the police in case of traffic crashes)
|
inclusion date
|
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Seriousness of the accident
大体时间:inclusion date
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The seriousness of the accident is assessed according the duration of hospital stay.
If the duration is less than 24 hours, accidents are considered as non serious.
If not, accidents are considered as serious.
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inclusion date
|
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Knowledge of drivers about graded pictogram featured on drugs packaging
大体时间:inclusion date
|
Knowledge about graded pictogram is collected during a structured interview administered by a trained CRA.
Measure title : percentage of drivers who know if a pictogram is featured on their drugs packagings.
|
inclusion date
|
合作者和调查者
调查人员
- 学习椅:Nicholas MOORE, Pr、Plateforme BPE
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CHUBX 2012/33
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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