XYREM EU-RMP: Effectiveness Assessment Protocol of Educational Materials

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey

Study drug and medical condition

• Name of medicine:
  XYREM

Population studied

• Short description of the study population:
  XYREM prescribers from Belgium, Germany, Italy, Spain, Sweden, and the UK to whom the XYREM educational materials were sent.; Physicians were required to meet the following inclusion criterion:; 1. Must have been included on the XYREM RMP educational materials mailing list
• Age groups:
  • 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)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  Evaluate the effectiveness of the educational material RMMs implemented in the EU to mitigate the important identified risks of respiratory and CNS depression, depression/suicidality, abuse/misuse of XYREM, diversion/criminal use, overdose, dependency/withdrawal, and interactions of XYREM with alcohol, the important potential risks associated with sodium overload in patients prescribed XYREM.
• Outcomes:
  Proportion of respondents providing a correct response for each individual question consistent with the XYREM summary of product characteristics (SmPC).
• Data analysis plan:
  The primary outcome of the survey is the proportion of prescribers providing a correct response for each individual question in the key risk messages consistent with the XYREM EU SmPC. This is computed as the proportion of prescribers who correctly respond to the individual survey questions concerning the appropriate dosing and important identified risks of XYREM as described in the XYREM SmPC. The proportion responding correctly will be tabulated separately for each item in the survey instrument. Point estimates for the proportion with correct responses, and associated 95% confidence intervals, will be calculated for each question. In the case of multiple choice questions, the number and proportion of prescribers reporting each response will also be provided. Information obtained from the survey will be reported as descriptive statistics for the survey administration, survey population, and the survey questions.