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Elizabeth Tschosik, Audrey Kapre, Daniela Ferrara, Margaret Chang; Content validity of the Port Delivery System with ranibizumab Patient Preference Questionnaire. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5379.
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© ARVO (1962-2015); The Authors (2016-present)
The Port Delivery System with ranibizumab (PDS) is an investigational, surgically implanted, refillable intraocular implant designed for continuous delivery of a customized formulation of ranibizumab into the vitreous. The PDS Patient Preference Questionnaire (PPPQ) is a 3-item questionnaire intended to capture patient preference between treatment with the PDS and intravitreal anti-VEGF injections, the strength of preference, and the reasons for preference. To establish content validity of the questionnaire, patients were recruited to provide feedback on the relevance, clarity, and understandability of the PPPQ using qualitative interviews.
Patients were recruited from the PDS arms of the phase 2 Ladder trial (NCT02510794) that compared the PDS with intravitreal ranibizumab injections in patients with neovascular AMD. Recruited patients were invited to participate in a 1:1 interview in person or via phone. Patients were selected based on availability and to ensure a mix of gender and geographic location. A semi-structured Interview Guide was used to administer the PPPQ and conduct the questionnaire cognitive debriefing.
11 patients were interviewed from 6 US study sites; 6 patients were female, 5 were male and mean age was 78 years (range 63–95). 10 of the 11 patients interviewed preferred the PDS over intravitreal anti-VEGF injections. Overall, patients thought PPPQ questions were understandable, clear, and relevant. No patients reported difficulty recalling their prior intravitreal treatments. Iterative changes were made to the Interview Guide and PPPQ based on patient feedback. Minor edits were made to the instructions and the overall preference question to aid comprehension. The strength of preference item was easily understood and was not changed. Patients had some difficulty remembering the response options for the reasons for preference item and considered some response options to be unclear. Therefore, response options were revised for simplicity and clarity in order to allow respondents to select all applicable answers.
This study showed the relevance and content validity of the PPPQ for nAMD patients. Results of these interviews helped identify and support revisions to the PPPQ items. The final revised PPPQ, which will be included in the PDS phase 3 Archway trial (NCT03677934), may provide meaningful patient experience data in a clinical trial setting.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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