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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| serious road accidents | Drivers involved in serious road accidents (hospitalization > 24 hours) | ||
| non-serious road accidents | drivers involved in non-serious road accidents (hospitalization < 24 hours). |
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| Measure | Description | Time Frame |
|---|---|---|
| Drugs use reported by drivers involved in road accidents | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Responsibility of the driver for the accident | 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 |
| Seriousness of the accident |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a multicentre observational study that will include 2 populations: drivers involved in serious road accidents (hospitalization > 24 hours) and non-serious road accidents (hospitalization < 24 hours). The drivers involved in road accidents and admitted in an emergency department will be identified during daily visits (except on week end) by Clinical Research Associates (CRA) of the different centres. As soon as possible, a structured validated interview will done by a trained CRA.
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas MOORE, Pr | Plateforme BPE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin | Bordeaux | 33000 | France | |||
| CH de Perigueux |
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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. |
| inclusion date |
| Knowledge of drivers about graded pictogram featured on drugs packaging | 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 |
| Périgueux |
| France |