Construct Validity of Inherited Retinal Disease–Specific Patient-Reported Outcome Measures

• Published in: American journal of ophthalmology Vol. 248; pp. 116 - 126
• Main Authors: Jayasundera, K. Thiran, Abuzaitoun, Rebhi O., Popova, Lilia, Abalem, Maria Fernanda, Andrews, Chris A., Lacy, Gabrielle D., Fresco, David M., Musch, David C.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2023
• Subjects: Female; Humans; Male; Patient Reported Outcome Measures; Quality of Life; Retinal Diseases - diagnosis; Retinal Diseases - genetics; Sickness Impact Profile; Surveys and Questionnaires; United States; Vision Disorders; Vision, Ocular; Visual Acuity; United States
• ISSN: 0002-9394; 1879-1891; 1879-1891
• DOI: 10.1016/j.ajo.2022.11.021

To evaluate aspects of construct validity of the Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-related Anxiety Questionnaire (MVAQ). Subjects with a clinical diagnosis of an inherited retinal disease (IRD) were recruited prospectively and 3 tests were used to assess construct validity: the ability to distinguish different IRD phenotypes; test a priori hypothesis of an association between vision-related anxiety and vision-related disabilities; and correlate MRDQ and MVAQ with the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) and the Impact of Vision Impairment (IVI). One-way analysis of variance (ANOVA) was used to compare different phenotypes for mean domain scores for MRDQ/MVAQ. Pearson correlations were performed between; Cone-Function Anxiety and Central Vision controlling for better eye visual acuity, Rod-Function Anxiety and Scotopic Function controlling for visual field area (III4e and IV4e), and scores of MRDQ/MVAQ, NEI VFQ-25, and IVI. The study sample consisted of 146 patients evenly divided between males and females, and mean age was 50 years. The 1-way ANOVA test was significant for distinguishing IRD phenotypes in 6 domains of MRDQ/MVAQ. Cone-Function Anxiety correlated with Central Vision controlling for visual acuity, Rod-Function Anxiety correlated with Scotopic Function controlling for visual field area, and all domains in MRDQ/MVAQ had significant correlations with NEI VFQ-25 and IVI composite scores. MRDQ and MVAQ domenstrate aspects of construct-validity set forth by the US Food and Drug Administration. The study futher supports the use of both patient-reported outcome measures in IRD clinical trials and natural history studies.NOTE: Publication of this article is sponsored by the American Ophthalmological Society.