DARWIN EU® - Incidence of suicidality in patients with specific chronic skin conditions

Study type

• Study topic:
  Disease /health condition
• Study topic, other:
  Chronic skin conditions
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acne

  Psoriasis

Population studied

• Short description of the study population:
  The study population will include all individuals present in the database during the study period (2010 to the most recent data available) and with at least one year of database history. ; Within this population 2 sub-cohorts will be nested namely one on individuals newly diagnosed with acne and one consisting of individuals newly diagnosed with psoriasis. ;

Study design details

• Study design:
  Population level cohort study
• Main study objective:
  1. To assess the incidence rate of i) completed suicide, ii) attempted suicide, iii) suicide ideation, iv) intentional self-harm, v) suicide-related events (i.e. completed suicide, attempted suicide, and suicidal ideation), vi) composite outcomes (combination of all above mentioned events) in patients with acne stratified by sex, age category (12-<18 years, 18-30, 31-40, 41-50 etc, >=81 years), calendar year, and history of mental health disorders. ; 2. To assess the incidence rate of i) completed suicide, ii) attempted suicide, iii) suicide ideation, iv) intentional self-harm, v) suicide-related events (i.e. completed suicide, attempted suicide, and suicidal ideation), vi) composite outcomes (combination of all above mentioned events) before in patients with psoriasis stratified by sex, age category (12-<18 years, 18-30, 31-40, 41-50 etc, >=81 years), calendar year, and history of mental health disorders ; 3. To assess the incidence rate of i) completed suicide, ii) attempted suicide, iii) suicide ideation, iv) intentional self-harm, v) suicide-related events (i.e. completed suicide, attempted suicide, and suicidal ideation), vi) composite outcomes (combination of all above mentioned events) before in the general population stratified by sex, age category (12-<18 years, 18-30, 31-40, 41-50 etc, >=81 years), calendar year, and history of mental health disorders
• Setting:
  This study will be conducted using routinely collected data from 5 primary and secondary care data sources in 5 European countries. All data were a priori mapped to the OMOP CDM.
• Outcomes:
  Outcomes of interest are i) completed suicide, ii) attempted suicide, iii) suicide ideation or iv) intentional self-harm, v) suicide-related events (i.e. completed suicide, attempted suicide, and suicidal ideation), vi) composite outcomes (combination of all above mentioned events).

Documents

Study report

DARWIN EU_Report_P3-C1-010_Skin conditions and suicidality_V3.pdf