Health and Road Safety: Influence of Drugs Use and Health Status
NCT ID: NCT02688504
Last Updated: 2020-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2016-10-18
2018-12-26
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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serious road accidents
Drivers involved in serious road accidents (hospitalization \> 24 hours)
No interventions assigned to this group
non-serious road accidents
drivers involved in non-serious road accidents (hospitalization \< 24 hours).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Aged over 18 years
* Able to respond to a structured questionnaire
* Having agreed to participate in the study
Exclusion Criteria
* Passenger
* Pedestrian
* Discharge or transfer to another hospital/clinic before the interview
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Nicholas MOORE, Pr
Role: STUDY_CHAIR
Plateforme BPE
Locations
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Hôpital Pellegrin
Bordeaux, , France
CH de Perigueux
Périgueux, , France
Countries
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Other Identifiers
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CHUBX 2012/33
Identifier Type: -
Identifier Source: org_study_id
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