Survey of prescriber understanding of specific risks associated with TROBALT (201426)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Physician survey
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Physician survey

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RETIGABINE

Population studied

• Short description of the study population:
  Physicians prescribing AEDs and who have been sent a DHCP letter in Austria, Belgium, France, Hongkong,Italy, Norway, Poland, Slovakia, Spain, Switzerland and the United Kingdom.; ; Physicians will be required to meet all the following inclusion criteria: ; 1. Must manage patients with epilepsy. ; 2. Must have prescribed an AED at least once in the last 6 months. ; 3. Must be on the list to which a DHCP letter was distributed in June 2013.; ; Physicians meeting any of the following criteria will not be eligible to take the survey: ; 1. Currently an employee of GSK or UBC.
• 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:
  0

Study design details

• Main study objective:
  The objective of this study is to assess prescribers’ awareness of recent label changes, including the appropriate patient population related to retigabine as evaluated by a survey instrument.
• Outcomes:
  The proportion of physicians providing correct responses to a series of questions concerning specific risks associated with retigabine
• Data analysis plan:
  The outcome of the survey is the proportion of physicians providing correct responses to a series of questions concerning specific risks associated with retigabine. Additional analyses will compare the level of understanding between physicians who have prescribed retigabine and those who have never or not recently prescribed the product.