DARWIN EU® - Drug utilisation study on medicinal use of Pelargonii radix

Study type

• Study topic:
  Herbal medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Pelargonii radix
• Additional medical condition(s):
  Common cold and acute bronchitis

Population studied

• Short description of the study population:
  Patient-level utilisation of selected medicines of interest: Patient-level drug utilisation analyses will include all treatment initiations of pre-specified medicines of interest in the period between 1st of January 2014 and 31st of December 2023. Patients need to have at least 365 days of data visibility prior to the date of their first prescription/dispensing and no use of the respective medication of interest in the previous 30 days. This requirement of at least 1 year of prior data history will not hold for children <1 year of age. ; ; Population-level utilisation of selected medicines of interest: Population-level drug utilisation analyses will include all individuals registered in the database between 1st of January 2014 and 31st of December 2023, with at least 365 days of data visibility prior to becoming eligible for study inclusion. This requirement of at least 1 year of prior data history will not hold for children <1 year of age.
• Age groups:
  Paediatric Population (< 18 years)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (>18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  • New drug user cohort study (Objective 1); • Population-level cohort study (Objectives 2)
• Main study objective:
  1. To characterise the cohort of patients being treated with Pelargonii radix at the time of each treatment initiation of the drug of interest in terms of demographics and indication for prescribing/dispensing. Additionally, to determine dose/strength at the treatment initiation, duration of treatment episodes and number of prescriptions of the drug of interest per treatment episode. All results will be stratified by age category (below 3; 3-5; 6-11; 12-17; 18-65, >65 years) and database. 2. To determine incidence of use of Pelargonii radix among different age categories (below 3; 3-5; 611; 12-17; 18-65, >65 years) by country/database, during the study period (2014-2023).
• Data analysis plan:
  Patient-level utilisation of selected medicines of interest: Patient level characterisation will be conducted at index date. Index date will be the date at time of first prescription of each new treatment episode of the drug of interest for each person. The frequency of indication of drug use will be assessed by searching for predefined disease categories. Additionally, top 10 SNOMED codes reported in window around index date will be determined. Initial dose/strength will be estimated, and the minimum, quartiles and maximum values will be provided. Duration of treatment episodes will be calculated and summarized providing the minimum, quartiles, and maximum duration of treatment episodes. Number of prescriptions per treatment episode will be estimated and minimum, quartiles and maximum number of repeated prescriptions of the index drug will be reported. The statistical analyses will be conducted using the “DrugUtilization” R Package based on OMOPCDM mapped data and will be stratified by age category (below 3; 3-5; 6-11; 12-17; 18-65, >65 years) and database. ; ; Population-level utilisation of selected medicines of interest: Incidence rate of use of medicines of interests, expressed as numbers of treatment initiations per person-year, will be estimated in separate age categories (below 3; 3-5; 6-11; 12-17; 18-65, >65 years) (Objective 2). The statistical analyses will be performed based on OMOP-CDM mapped data using “IncidencePrevalence” R package. ; ; For all analyses a minimum cell counts of 5 will be used when reporting results, with any smaller counts obscured.