Prevalence of Acute Liver Injury

Study type

• Study topic:
  Disease /health condition
• 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:
  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Medical condition to be studied:
  Liver injury

Population studied

• Short description of the study population:
  The study included patients visiting general practices in France, Italy, Germany, Romania, and Spain to determine the prevalence of acute liver injury, between January 2016 and December 2020, identified from the IMRD databases.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  300000

Study design details

• Main study objective:
  The main objective of the study was to estimate the yearly prevalence of acute liver injury in five EU countries (Germany, France, Italy, Romania, and Spain), overall and stratified by gender and age group (0-17 years, 18-49 years, 50-79 years, 80+ years).
• Data analysis plan:
  The prevalence was estimated as the number of patients with the condition anytime during the year according to the case definition (i.e. all patients that were observable during the year and had received a diagnosis of acute liver injury during the year or up to 181 days before the start of the year) per million persons in the population that were observable during the year. The period of 181 days was only applied to the first date when the specific diagnosis was recorded in the patient, but the same patient could contribute to more than one 181-day period if more than one acute liver injury diagnosis was recorded.

Documents

Study results

Report Results - Acute liver injury prevalence_For_Publication_CLEAN_final