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.

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Key information

Conditions

Drug Exposition Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposition to hypnotics or anxiolytics benzodiazepines

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)

Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics

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)

Medical consultation without prescription

Other

Medical consultation without prescription of any drugs of interest

Administrative and medical data

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)

Primary outcomes

Comparison of mortality from all causes in the 3 groups as assessed by clinical data collected

Time frame: through 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 11, 2016
Registry last updated: Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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