Clinical trial NCT04480996: Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)
Official title: Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Accident, Traffic
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects

Brief summary: Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving skills and road traffic accidents. This study investigates reports of road traffic accident for different class of drugs responsible for cognitive and psychomotor sides effects (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed description: Some medications are responsible of a wide range of cognitive and psychomotor side effects that may make it unsafe to drive and lead to risks of road accidents .The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of road traffic accidents following treatment with different class of drugs responsible for pyschomotor sides effects.

Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/03/2020
* Adverse events reported were including the MedDRA terms: Road Traffic Accident (SMQ)
* Patients treated with at least one liable nervous system drugs (ATC class N) or that can induce cognitive and pyschomotor undesirable effects by crossing the blood-brain barrier (ATC class A04, C02A, L)

Exclusion Criteria:

* Chronology not compatible between the drug and the road traffic accident

Primary outcomes:
measure: Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
Secondary outcomes:
measure: Association between two drugs of the same class, leading to an over-reporting of road traffic accidents
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
measure: Description of the population of patients having a road traffic accident related to taking medication
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
state: Normandie
Study officials:
affiliation: CHU CAEN
name: Véronique Lelong-Boulouard, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chretien B, Nguyen S, Dolladille C, Morice PM, Heraudeau M, Loilier M, Fedrizzi S, Bourgine J, Cesbron A, Alexandre J, Bocca ML, Freret T, Lelong-Boulouard V. Association between road traffic accidents and drugs belonging to the antiseizure medications class: A pharmacovigilance analysis in VigiBase. Br J Clin Pharmacol. 2023 Jan;89(1):222-231. doi: 10.1111/bcp.15481. Epub 2022 Aug 21.