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Diana V Do, Steven Sherman, Adele Levine, Patrick Marquis, Christopher Hartford, Rohini Rao, Diana Rofail; Development of a New Patient-Reported Outcome Instrument to Assess Diabetic Retinopathy Treatment Experiences. Invest. Ophthalmol. Vis. Sci. 2022;63(7):816.
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To develop a de novo patient-reported outcome (PRO) questionnaire for assessing the impact of treatment with anti-vascular endothelial growth factors (VEGFs) versus panretinal photocoagulation (PRP) on patients’ experience of living with proliferative diabetic retinopathy (PDR).
A review of literature and online resources was conducted to develop a conceptual model of the PDR patient experience and to identify existing PROs used in PDR and other ophthalmic conditions. Concept-to-item mapping of the identified PROs was conducted to identify items relevant to the patient disease and treatment experiences. This formed the initial PRO instrument, which was further refined using insights gained from adult patients treated with aflibercept and/or PRP. Two rounds of in-depth, semi-structured interviews were conducted to elicit patients’ feedback on living with PDR and treatment experiences and to assess their ability to interpret the PRO content and its relevance to their experience.
Forty patients treated with aflibercept (n=23) and/or PRP (n=34) for PDR were interviewed during Round 1 and of these, 30 were later interviewed in Round 2. An initial list of 72 items with conceptual coverage across symptoms and impact domains was drafted based from existing instruments relevant for PDR. Patients’ feedback led to refinement of instructions, items, and response options to improve clarity and comprehension, remove overlap, and increase relevance. A new scale was added to enable assessment of concepts proximal to experience of PRP or anti-VEGF treatment. The revised PRO measure and preliminary conceptual framework includes 85 items across four scales: Daily activities (54), Emotional impact (5), Vision problems (15), and Treatment experience (11).
A robust and comprehensive PRO instrument was developed to evaluate the effects experienced by patients who are treated for their PDR. A validation study in a larger sample is warranted to confirm scoring, item reduction opportunities, and psychometric properties.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.
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