Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Trimetazidine in Bulgaria, Czech Republic, Estonia, France, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, and Spain

Study type

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TRIMETAZIDINE

Population studied

• Short description of the study population:
  Physicians who were prescribers, or potential prescribers, of TRIMETAZIDINE; and specialists of any of those targeted for the DHPC: ENT-specialists, ophthalmologists, cardiologists, others (GPs, internists, geriatricians).
• Age groups:
  Preterm newborn infants (0 – 27 days)

  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)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  Primary objective: • to evaluate the proportion of targeted physicians who received, understood and agreed to implement the updated information about TMZ provided in the DHPC
• Data analysis plan:
  All analysis will be descriptive in nature and no statistical comparison will be done in this study. Results will be presented overall, by country and per specialty. Quantitative data will be summarized descriptively using n, mean, median, standard deviation, minimum and maximum. Categorical data will be summarized using frequency and percentage. 95% confidence interval (Wald’s) may be constructed around the percentage values for some variables. Some of the variables may also be summarized by country. All variables will be analyzed in total and separately for ophthalmologists, ENT specialists, cardiologists and others based on the information provided.In a first step, calculations will be performed on raw data. In a second step, the results will be weighted according to the real proportion of physicians in each country