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

Completed

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

• Registration Number: NCT02827331
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171861

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients exposed to benzodiazepines	Administrative and medical data	Data to be collected are : * Administrative and medical data * Exposition to hypnotics or anxiolytics benzodiazepines
Control group	Medical consultation without prescription	Data to be collected are : * Administrative and medical data * Medical consultation without prescription of interest
Control group	Administrative and medical data	Data to be collected are : * Administrative and medical data * Medical consultation without prescription of interest
Patients not exposed to benzodiazepines	Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics	Data to be collected are : * Administrative and medical data * Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics
Patients exposed to benzodiazepines	Exposition to hypnotics or anxiolytics benzodiazepines	Data to be collected are : * Administrative and medical data * Exposition to hypnotics or anxiolytics benzodiazepines
Patients not exposed to benzodiazepines	Administrative and medical data	Data to be collected are : * Administrative and medical data * Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics

Primary Outcome Measures

Name	Time	Method
Comparison of mortality from all causes in the 3 groups as assessed by clinical data collected	through the end of study (12 months)	Four approaches will be used : * intergroup comparison; * Time influence with cox model; * Use of markovian models; * Inclusion of "non observable periods" with inobservable and observable death models