Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients exposed to benzodiazepines Data to be collected are : Administrative and medical data Exposition to hypnotics or anxiolytics benzodiazepines |
Other: Exposition to hypnotics or anxiolytics benzodiazepines
Exposition to at least one drug belonging to the following classes during the last 12 months before index date :
Benzodiazepine derivatives (N05BA)
Benzodiazepine derivatives (N05CD)
Benzodiazepine related drugs (N05CF)
Other: Administrative and medical data
Gender
Birthdate
Department of residence
City of residence
Vital status (month and date of death)
Affiliation to Universal Health Coverage
Number of chronic long-term illness, medical diagnostic or pathology (CIM 10 code), onset and end dates
Drugs reimbursements (Date of care onset, drugs identification code, number of box delivered)
Data collected from medicalisation program of information system and private and public home care structures
Medical consultations, medical acts ( Common Classification of Medical Acts nomenclature)
|
| Patients not exposed to benzodiazepines Data to be collected are : Administrative and medical data Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics |
Other: Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics
Exposition to at least one drug belonging to the following classes during the last 12 months before index date :
Antipsychotics (N05A)
Antiepileptics with the exception of clonazepam (N03)
Drugs used for alcohol dependance (N07BB)
Drugs used for opioids dependance (N07BC)
Other: Administrative and medical data
Gender
Birthdate
Department of residence
City of residence
Vital status (month and date of death)
Affiliation to Universal Health Coverage
Number of chronic long-term illness, medical diagnostic or pathology (CIM 10 code), onset and end dates
Drugs reimbursements (Date of care onset, drugs identification code, number of box delivered)
Data collected from medicalisation program of information system and private and public home care structures
Medical consultations, medical acts ( Common Classification of Medical Acts nomenclature)
|
| Control group Data to be collected are : Administrative and medical data Medical consultation without prescription of interest |
Other: Medical consultation without prescription
Medical consultation without prescription of any drugs of interest
Other: Administrative and medical data
Gender
Birthdate
Department of residence
City of residence
Vital status (month and date of death)
Affiliation to Universal Health Coverage
Number of chronic long-term illness, medical diagnostic or pathology (CIM 10 code), onset and end dates
Drugs reimbursements (Date of care onset, drugs identification code, number of box delivered)
Data collected from medicalisation program of information system and private and public home care structures
Medical consultations, medical acts ( Common Classification of Medical Acts nomenclature)
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Study Director: Maryse LAPEYRE-MESTRE, University Hospital of Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31-14-7439