Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada
Study Details
Study Description
Brief Summary
The primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Questionnaires for physicians will be developed and tested using best practices for instrument development. The questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the Eylea product monograph.
Other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with Eylea).
The questionnaire will be tested through cognitive interviews with physicians. Questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Eylea product and application information / Cohort 1 Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept. |
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
The physician questionnaire will contain primarily closed-ended questions (e.g., multiple choice, true/false), with few free-text response fields, eliciting responses measuring physician knowledge and understanding of the key information in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.
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Outcome Measures
Primary Outcome Measures
- Knowledge and understanding of key information contained in the aflibercept educational materials: the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph [Up to 8 weeks after the start of data collection]
The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices.
Secondary Outcome Measures
- Investigation whether physicians have received the educational materials [up to 6 month]
Descriptive results assessing Number and percentage (%) of physicians
Eligibility Criteria
Criteria
Inclusion Criteria:
This study will be conducted with retinal specialists and ophthalmologists in Canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months.
Exclusion Criteria:
- None applied
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Canada |
Sponsors and Collaborators
- Bayer
- Regeneron Pharmaceuticals
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18498