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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Bordeaux, Frankrijk, 33000
- Hôpital Pellegrin
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Périgueux, Frankrijk
- CH de Périgueux
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Dwarsdoorsnede
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Drugs use reported by drivers involved in road accidents
Tijdsspanne: 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.
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inclusion date
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Responsibility of the driver for the accident
Tijdsspanne: inclusion date
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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)
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inclusion date
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Seriousness of the accident
Tijdsspanne: 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
Tijdsspanne: inclusion date
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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.
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inclusion date
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Nicholas MOORE, Pr, Plateforme BPE
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CHUBX 2012/33
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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