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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Bordeaux, Frankrike, 33000
- Hôpital Pellegrin
-
Périgueux, Frankrike
- CH de Périgueux
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Drugs use reported by drivers involved in road accidents
Tidsramme: inclusion date
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Responsibility of the driver for the accident
Tidsramme: 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
|
|
Seriousness of the accident
Tidsramme: inclusion date
|
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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Nicholas MOORE, Pr, Plateforme BPE
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CHUBX 2012/33
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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