Quantitative Testing of Patient and Prescriber Knowledge, About GATTEX (Teduglutide) for Injection Safety and Use Information

Study type

• Study topic:
  Other
• Study topic, other:
  Assessment of healthcare provider and patient knowledge, attitudes, and behaviors regarding Gattex risks and safe use
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Knowledge Assessment Survey
• 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

• Medicinal product name, other:
  GATTEX
• Study drug International non-proprietary name (INN) or common name:
  TEDUGLUTIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A16AX08) teduglutide

  teduglutide
• Medical condition to be studied:
  Short-bowel syndrome

Population studied

• Short description of the study population:
  The population of prescribers and potential participants identified from the GATTEX REMS database at a given point in time who met the inclusion criteria and none of the exclusion criteria would be invited to participate in the Wave 8 of the Gattex Knowledge Assessment Survey.
• 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:
  600

Study design details

• Main study objective:
  The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey). This survey, which is conducted every two years, is part of the Gattex Risk Evaluation and Mitigation Strategy (REMS). REMS is a safety program required by the US health authority (FDA) for certain medicines that have serious risks. REMS intends to help reduce these risks while still allowing treatment. The goal is to make sure these medicines are used in the safest way possible. The main aim of this survey is to find out how well participants and physicians understand the checkups and tests (so called monitoring) participants should have while taking GATTEX, and the possible risks or of using GATTEX to treat Short Bowel Syndrome.; The knowledge assessment survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred.; No study medicines will be provided to participants in this study.
• Outcomes:
  Number of Participants and Prescribers Providing Correct Responses to Questions. ; Number of Participants and Prescribers Providing Correct Responses (80%) to and ; Demonstrated Understanding of Survey Knowledge Domains.;
• Data analysis plan:
  Detailed statistical analysis methods will be conducted as described in the SAP for this study. Data will be summarized with tabulated descriptive statistics: number of observations, minimum, maximum, mean, median, standard deviation, and range for continuous variables and counts and percentages for categorical variables. In addition, graphical data displays will be used to summarize selected data.