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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02827331
Enrollment
171861
Registered
2016-07-11
Start date
2014-09-30
Completion date
2016-04-30
Last updated
2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Exposition

Keywords

Benzodiazepines, Fracture

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.

Interventions

OTHERMedical consultation without prescription

Medical consultation without prescription of any drugs of interest

OTHERExposition 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)

OTHERExposition 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)

OTHERAdministrative 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)

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of mortality from all causes in the 3 groups as assessed by clinical data collectedthrough 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026