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

Study Overview
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Brief Summary
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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.

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

Conditions
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Drug Exposition

Intervention / Treatment
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* Other: Exposition to hypnotics or anxiolytics benzodiazepines
* Other: Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics
* Other: Medical consultation without prescription
* Other: Administrative and medical data


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients exposed to benzodiazepines<br>Data to be collected are : Administrative and medical data Exposition to hypnotics or anxiolytics benzodiazepines | Other: Exposition to hypnotics or anxiolytics benzodiazepines<br>* 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)<br>Other: Administrative and medical data<br>* 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)<br>|
| Patients not exposed to benzodiazepines<br>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<br>* 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)<br>Other: Administrative and medical data<br>* 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)<br>|
| Control group<br>Data to be collected are : Administrative and medical data Medical consultation without prescription of interest | Other: Medical consultation without prescription<br>* Medical consultation without prescription of any drugs of interest<br>Other: Administrative and medical data<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 : intergroup comparison Time influence with cox model Use of markovian models Inclusion of non observable periods with inobservable and observable death models | through the end of study (12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benzodiazepines, Fracture