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The question of the inclusion of periods of interruptions and periods unobservable has been studied as part of medico-administrative databases. However, the specificity of the health insurance databases justify the realization of dedicated methodological research. A thorough knowledge of the purpose of these data, how they collect and restitution is an essential prerequisite to carry out this work.
One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis of the comparison between the exposure groups. However, this traditional approach has the major drawback of neglecting the changing nature of drug exposure, and therefore fails to take into account any changes or interruptions doses. Approaches to take into account the time dependent variables were developed. These allow to take into account any interruptions. However, as part of study on health databases, sometimes we do not have the status in relation to the exhibition on the entire monitoring period. This is for example the case during hospitalization. The bias generated by the failure to take account of these periods ("non measurable time bias") can be problematic when a long exposure and chronic disorders require hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients exposed to benzodiazepines | Data to be collected are :
|
| |
| Patients not exposed to benzodiazepines | Data to be collected are :
|
| |
| Control group | Data to be collected are :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposition to hypnotics or anxiolytics benzodiazepines | Other | Exposition to at least one drug belonging to the following classes during the last 12 months before index date :
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of mortality from all causes in the 3 groups as assessed by clinical data collected | Four approaches will be used :
| through the end of study (12 months) |
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General Inclusion Criteria:
Group expose to benzodiazepine :
Group antidepressants and anxiolytics and hypnotics non benzodiazepines :
Control group :
- Patient having a medical consultation without prescription of interest
Exclusion Criteria:
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Population studied is from french general sample of beneficiaries. Patients are incident users of benzodiazepines
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| Name | Affiliation | Role |
|---|---|---|
| Maryse LAPEYRE-MESTRE | University Hospital of Toulouse | Study Director |
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| Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics | Other | Exposition to at least one drug belonging to the following classes during the last 12 months before index date :
|
|
| Medical consultation without prescription | Other | Medical consultation without prescription of any drugs of interest |
|
| Administrative and medical data | Other |
|
|
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006993 | Hypnotics and Sedatives |
| D014151 | Anti-Anxiety Agents |
| D055656 | Prescriptions |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D014149 | Tranquilizing Agents |
| D011619 | Psychotropic Drugs |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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