Calibrating the impact of vision impairment (IVI): Creation of a sample-independent visual function measure for patient-centered outcomes research

Purpose: Provide item calibrations estimated for the Impact of Vision Impairment (IVI) questionnaire by pooling data from several studies of people with vision impairment (VI) representing a variety of countries and causes of VI. Methods: Eight data sets from six principal investigators representing responses to IVI items from 2867 VI patients were pooled for analysis. Eligible patients were 18 years or older and from Australia, India, and the United States. Rasch analysis, using the Andrich Rating Scale Model (Winsteps version 3.65), was performed on preinterven-tion IVI responses to estimate item and person measures, reliability coefficients, and response category thresholds. Differential item functioning (DIF) analysis and analysis of variance (ANOVA) were used to examine the effects different data sets and covariates on item estimates. Results: Patient age range was 18 to 103 years (median 62 years); 55% were male. Visual acuity ranged from 20/20 to no light perception and primary diagnosis was macular degeneration in 29% of patients. Item measure estimates showed good separation reliability (R² = 0.99). DIF magnitude did not preclude use of all IVI-28 data. ANOVA showed VA (P < 0.001) and gender (P < 0.002) were predictors of visual ability. Conclusions: Analysis from pooled data support the provision of calibrated IVI item measures for researchers and clinicians to use, thus better enabling direct comparisons of patients with VI. Translational Relevance: Validity testing of the IVI show that we can combine disparate data sets of patient responses to calibrate item measures and response category thresholds, and provide to others for use in comparing patients across clinical trials and on an individual basis.