Effectiveness Evaluation of PALFORZIA Risk Management Plan Educational Materials

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (V01AA08) food

  food
• Medical condition to be studied:
  Food allergy

Population studied

• Age groups:
  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:
  165

Study design details

• Main study objective:
  Main objective: Verification of the understandability and retention of core educational material messages by healthcare professionals (HCPs, parent/caregiver and patients)
• Outcomes:
  The educational materials will be considered effective if the minimum score of 80% correct responses on questions designed to assess core messages is obtained and there is 100% adherence to the educational material distribution plan to healthcare professionals, parents/caregivers, and patients
• Data analysis plan:
  Prior to analyzing survey data, the data will be cleaned to address missing information and potentially dishonest responses. Completed surveys will be monitored to ensure that the final sample size for analysis includes the appropriate number of valid surveys. For each country, the raw data will be analyzed and reported for each of the three study populations. The following will be reported: the total number of completed participant surveys obtained and included in the analysis (including any known reasons for non-participation), a description of participant demographics, a description of participant responses to each knowledge and process question, the percentage of respondents answering each question correctly, and a description of the overall average percent of participants who answered questions accurately, clearly identifying those domains that met the targeted outcome. Results from each of the countries will also be aggregated and reported.