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

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

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.