DARWIN EU® - Capturing suicidality and depression related variables in databases

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Feasibility analysis

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

No information provided.

Population studied

• Short description of the study population:
  For objective 1 and 2c, the general population will constitute the study population: ; Inclusion criteria ; • Minimum 365 days of available history before index date (except for hospital data sources) ; • Aged ≥10 years of age. This age cutoff is based on the World Health Organisation (WHO) definition for adolescence (age 10 to 19), since we do not expect relevant results in lower age groups.[3] ; For objective 2a, 2b. and 3: ; Inclusion criteria; • Minimum 365 days of available history before index date (except for hospital data sources) ; • Aged ≥10 years of age ; • Condition or observation of completed suicide, suicide-related events (suicide attempt, suicide ideation, or self-harm), or depression

Study design details

• Study design:
  The retrospective cohort study will comprise of: ; • A descriptive epidemiology study including the general population will be conducted to address objective 1 and 2c. ; • A descriptive study including individuals with the events of interest will be conducted to address objective 2a, 2b, and 3.
• Main study objective:
  To estimate the incidence and prevalence of individuals with a record of suicide, suicide-related ; events, depression, healthcare utilisation, symptom measurement data, procedures, and ; depression remission within the DARWIN EU® network. ; 2. To characterise reporting of suicide, suicide-related events, depression, symptom measurement, ; healthcare utilisation, and resolution reporting within the DARWIN EU® network in terms of: ; a) Mean and median of number of event reporting per individual within the study period. ; b) The mean cumulative function of event recording ; c) Describe the values of depression symptom measurement data. ; 3. To describe the characteristics of individuals with records of suicide, suicide-related events, and ; depression in terms of demographic characteristics, concomitant medications, comorbidities, ; procedures, and lifestyle factors.
• Setting:
  This study will be conducted using routinely collected data from 23 data sources in the DARWIN EU® network of data partners from 14 European countries, of which 12 EU member states. All data were a priori mapped to the OMOP CDM.
• Summary results:
  CONCLUSION ; This study characterised data on suicide, suicide-related events, and depression from available data sources in the DARWIN EU® network at the time the study was initiated. This study provides information on data quality, in particular extensiveness and relevance, to identify missing data, suggest areas for improvement and support fit-for-purpose assessments for future studies in this area. Data sources such as BIFAP, DK DHR, HI-SPEED, NAJS, NLHR, and to a lesser extent CPRD GOLD and VID, appear to more comprehensively capture suicide-related events. Whilst completed suicide was observed, the limited number of events in many data sources suggests that capture of this outcome may be incomplete or heterogeneous across data sources.