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

NCT02827331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 171861

Last updated 2016-09-05

No results posted yet for this study

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

Interventions

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

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

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)

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Maryse LAPEYRE-MESTRE · University Hospital of Toulouse

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

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Read the full study record

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View NCT02827331 on ClinicalTrials.gov