Health and Road Safety: Influence of Drugs Use and Health Status

Study Overview
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Brief Summary
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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.

Official Title
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CESIR-U2 : Influence of Drugs Use and Health Status

Conditions
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Car Accident

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| serious road accidents<br>Drivers involved in serious road accidents (hospitalization > 24 hours) | |
| non-serious road accidents<br>drivers involved in non-serious road accidents (hospitalization < 24 hours). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labelled medicines, drivers involved in serious and non-serious road accidents, relevance and effectiveness of pictograms on medicines packaging