Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge on Dosing and Administration of Obizur® (Susoctocog alfa) in 6 European Countries

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Multinational web based survey

Study drug and medical condition

• Name of medicine:
  OBIZUR

Population studied

• Short description of the study population:
  A survey of healthcare professionals (HCPs) who treated patients with acquired haemophilia caused by antibodies to Factor VIII (AHA) by prescribing Obizur® (susoctocog alfa) in 6 selected European countries (Belgium, Germany, Italy, Netherlands, Sweden, UK).
• 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)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The overall research question is to evaluate whether healthcare professionals expected to prescribe or dispense Obizur have been successfully informed by the educational materials regarding the method of calculation and administration of Obizur.
• Outcomes:
  Success rates will be determined: Success if o Proportion of HCPs remembering having received the educational materials ≥60% AND o ≥80% of HCPs knowledgeable of the educational materials content AND o Proportion of HCPs who would or did prescribe, calculate the dose of, or dispense Obizur in line with the educational materials ≥60%, Success, if •≥70% of HCPs remember having received the EM • ≥70% HCPs are knowledgeable about the content of the EM Success, if •≥70%HCPs would prescribe, calculate the dose of, or dispense Obizur in line with the EM messages •≥80% of HCPs did prescribe, calculate the dose of, or dispense Obizur in line with the EM by collecting self-reported dosing and dispensing information
• Data analysis plan:
  Descriptive statistics will be applied. The endpoints will be assessed in overall, by country, and among different types of HCPs (physicians, pharmacists, nurses). Analyses by country will be performed in case if the number of HCPs per country will be >15. Continuous variables will be described by their number (of valid cases, of missing values), mean, standard deviation, and median, Q1, Q3, minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. These will be the percentage per category. Confidence intervals of 95% will be evaluated, when relevant. The proportions of correct and appropriate answers to selected questions asked in the questionnaire will be expressed among HCPs who provided answers to those questions .