A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using GATTEX

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to document the level of knowledge and assess attitudes and behaviors of both participants and physicians regarding the risks and safe use of GATTEX. The survey will be done via internet, telephone, or paper and patients will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.

Official Title
-----------------
Quantitative Testing of Patient and Prescriber Knowledge, Attitudes, and Behavior About GATTEX (Teduglutide) for Injection Safety and Use Information

Conditions
-----------------
Short Bowel Syndrome (SBS)

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Participant inclusion criteria: Participants who are 18 years of age or older and who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in the survey. A caregiver may participate in this survey on behalf of a patient who is eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge, Attitudes and Behavior (KAB) Survey, are eligible. Prescriber inclusion criteria: HCPs (adult and pediatric) in the United States who can provide a 10-digit National Provider Identifier (NPI) number and who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training (Prescriber Education Slide Deck) are eligible for participation in the survey. Note: HCPs who have previously participated in a GATTEX HCP KAB Survey, are eligible. Participant and Prescriber exclusion criteria: Respondents who do not agree to participate in the survey. Respondents who are currently working for and/or whose immediate family members who are currently working for Takeda Pharmaceutical Inc., NPS Pharmaceuticals, Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey. Respondents who reported having a conflict of interest. Further details associated with respondents who do not meet the exclusion criteria established above, will be provided in the assessment report.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GATTEX: Participants<br>Participants who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in this Risk Evaluation and Mitigation Strategy (REMS) survey for up to 10 years via internet, telephone, and paper. | Other: No Intervention<br>* This is non-interventional study.<br>|
| GATTEX: Healthcare Providers (Prescribers)<br>HCPs (adult and pediatric) in the United States (US) who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training are eligible for participation in this REMS survey for up to 10 years via internet, telephone, and paper. | Other: No Intervention<br>* This is non-interventional study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants and Prescribers Providing Correct Responses to Questions | All question for key risk message and about GATTEX will be asked through a questionnaire, Participant or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages | The questions will be asked to participants and HCPs and will be counted as correct if 80% of the correct responses are provided and not more than 1 incorrect response is provided. In key risk message, general question about GATTEX will be asked, participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs. | Up to 10 years | 
| Number of Participants and Prescribers who Demonstrated Understanding of Each key Risk Messages | Understanding demonstration is defined as respondents who answered 80% or more questions/items in a key risk message correctly. In key risk message, general question about GATTEX will be asked, participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs. | Up to 10 years |