Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up

Toulouse University Hospital

Status: Completed

Conditions: Drug Exposition

Treatments: Other: Medical consultation without prescription; Other: Exposition to hypnotics or anxiolytics benzodiazepines; Other: Administrative and medical data; Other: Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics

Study type: Observational

Funder types: Other

Identifiers

NCT02827331

RC31-14-7439

Details and patient eligibility

About

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.

Enrollment: 171,861 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

• Beneficiaries of all social security regimen with a minimum of one year of data in general sample of beneficiaries

Group expose to benzodiazepine :

• Exposition to at least one benzodiazepine or anxiolytic

Group antidepressants and anxiolytics and hypnotics non benzodiazepines :

• Exposition to at least one antidepressants and anxiolytics and hypnotics non benzodiazepines

Control group :

• Patient having a medical consultation without prescription of interest

Exclusion Criteria:

• Non incident patient : Patient having a prescription of benzodiazepines, clonazepam, tetrazepam, antidepressants, anxiolytics ou hypnotics non benzodiazepine during the last 12 months before index date

Trial design

171,861 participants in 3 patient groups

Patients exposed to benzodiazepines

Description:

Data to be collected are : * Administrative and medical data * Exposition to hypnotics or anxiolytics benzodiazepines

Treatment:

Other: Administrative and medical data

Other: Exposition to hypnotics or anxiolytics benzodiazepines

Patients not exposed to benzodiazepines

Description:

Data to be collected are : * Administrative and medical data * Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics

Treatment:

Other: Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics

Other: Administrative and medical data

Control group

Description:

Data to be collected are : * Administrative and medical data * Medical consultation without prescription of interest

Treatment:

Other: Medical consultation without prescription

Other: Administrative and medical data