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.

Study Overview

• Status: Completed
• Conditions: Car Accident

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hopital Pellegrin
  • Périgueux, France
    • CH de Périgueux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Nicholas MOORE, Pr, Plateforme BPE

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): December 26, 2018
• Study Completion (Actual): December 26, 2018

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: labelled medicines; drivers involved in serious and non-serious road accidents; relevance and effectiveness of pictograms on medicines packaging
• Other Study ID Numbers: CHUBX 2012/33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No