![]() Graded Response Models (GRM) from Item Response Theory (IRT) were fit to the data to assess questionnaire dimensionality, to estimate item information, and to score participants. The study was approved the University of Michigan Institutional Review Board. The questionnaire was re-administered after two weeks to 24 participants to assess repeatability. A 166-item questionnaire comprising 7 expert-defined domains was administered to 102 participants during a 35-50 minute telephone or in-person interview. Cognitive (n= 16) and pilot interviews (n=12) were conducted to refine questions and solicit patient feedback. Open-ended, in-depth interviews (n= 21) were performed and analyzed using Atlas.ti software to draft content items. Participants with a diagnosis of cone, cone-rod, rod-cone, or macular dystrophy were recruited between December 2016 and November 2019. This objective and psychometrically validated PRO measure is designed to detect a therapeutic effect of treatments for patients with IRDs. ![]() Through an extensive process of qualitative interviews and quantitative survey data analysis, this study presents a PRO questionnaire developed in accordance with U.S. ![]() Inherited retinal dystrophy (IRD) clinical trials are in need of a validated patient-reported outcomes (PRO) measure.
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