Systematic Review and meta-analysis of PASS Studies Assessing the Effectiveness of Risk Minimisation Measures

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

  Scoping review (including literature review)

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • 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)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To describe study characteristics, results, and regulatory consequences, in EU PASS RM Survey Study reports registered in the EU PAS Register.To quantify and pool (where appropriate) data on participation rates, receipt, knowledge, behaviour, use and reading in EU RM Survey Study reports registered in the EU PAS Register.
• Outcomes:
  Study characteristics, participation rates, receipt, knowledge, behaviour, use and reading, and regulatory consequences
• Data analysis plan:
  Analyses are mainly descriptive, with numbers. proportions and Forest plots and other graphs. Where feasible, aggregate study-level data will be pooled overall and by aRMM type using random and fixed effects models.