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

NCT ID: NCT02827331

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 171861 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Drug Exposition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients exposed to benzodiazepines

Data to be collected are :

• Administrative and medical data
• Exposition to hypnotics or anxiolytics benzodiazepines

Exposition to hypnotics or anxiolytics benzodiazepines

Intervention Type: OTHER

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)

Administrative and medical data

Intervention Type: OTHER

• 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

Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics

Intervention Type: OTHER

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)

Administrative and medical data

Intervention Type: OTHER

• 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

Medical consultation without prescription

Intervention Type: OTHER

Medical consultation without prescription of any drugs of interest

Administrative and medical data

Intervention Type: OTHER

• 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

Medical consultation without prescription

Medical consultation without prescription of any drugs of interest

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryse LAPEYRE-MESTRE

Role: STUDY_DIRECTOR

University Hospital of Toulouse

Other Identifiers

RC31-14-7439

Identifier Type: -

Identifier Source: org_study_id