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

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.

Study Overview

• Status: Completed
• Conditions: Drug Exposition
• Intervention / Treatment: Other: Exposition to hypnotics or anxiolytics benzodiazepines; Other: Administrative and medical data; Other: Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics; Other: Medical consultation without prescription

• Study Type: Observational
• Enrollment (Actual): 171861

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population studied is from french general sample of beneficiaries. Patients are incident users of benzodiazepines

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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: 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); 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)
Control group; Data to be collected are : Administrative and medical data; Medical consultation without prescription 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); Other: Medical consultation without prescription; Medical consultation without prescription of any drugs of interest

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Director: Maryse LAPEYRE-MESTRE, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Benzodiazepines; Fracture
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Antidepressive Agents; Anti-Anxiety Agents
• Other Study ID Numbers: RC31-14-7439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO