Injectors’ Survey to Assess Effectiveness of BELKYRA Risk Minimisation Activities

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

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

Study drug and medical condition

• Medicinal product name, other:
  Belkyra

Population studied

• Age groups:
  • 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:
  150

Study design details

• Main study objective:
  This study objective is to assess HCPs’ understanding of the key safety messages contained in the Injector’s Guide for the Safe Use of BELKYRA regarding injection site nerve injury and injection site skin ulceration
• Outcomes:
  The survey will evaluate the HCPs understanding of the key safety messages of BELKYRA as outlined in the Injector’s Guide for the Safe Use of BELKYRA
• Data analysis plan:
  • Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for responses to questions that address the survey objectives (i.e. excluding demographic questions). ; • Survey data will also be analysed by country and speciality (if number of respondents will be sufficient). ; • Data will also be analysed by countries in which the Injector’s Guide has been introduced vs. those countries that have not. Responses will be categorised as “Correct response” and “Incorrect response” ; • Each question will be assessed individually