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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Bordeaux、フランス、33000
- Hôpital Pellegrin
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Périgueux、フランス
- CH de Périgueux
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:断面図
コホートと介入
グループ/コホート |
|---|
|
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).
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Drugs use reported by drivers involved in road accidents
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Responsibility of the driver for the accident
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
捜査官
- スタディチェア:Nicholas MOORE, Pr、Plateforme BPE
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CHUBX 2012/33
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。