Abstract
Purpose :
Patient-reported outcome measures (PROMs) are commonly used in clinical trials and research in ophthalmology. Yet in order to be effective, the PROM instrument or questionnaire needs to be understandable to its respondents. The aim of this study was to assess the reading comprehension level of PROMs validated for use in common eye conditions.
Methods :
Twenty-four PROMs that had been previously validated for use in at least one of three common ophthalmological conditions (age-related macular degeneration, glaucoma and/or diabetic retinopathy) were included in this study. Reading comprehension level determines the readability that a text must have so that a reader understand the written materials; these were calculated using the Flesch-Kincaid Grade Level test, the FORCAST test, and the Gunning-Fog test using readability calculations software package Oleander Readability Studio 2012.1. The American Medical Association (AMA) and the National Institutes of Health (NIH) recommend readability of patient materials should not exceed a sixth-grade reading level. Number of PROMs requiring a reading level exceeding this threshold was calculated.
Results :
Median (interquartile range; IQR) readability scores were 6.7 (5.0, 9.3), 9.45 (8.6, 10.1) and 7.5 (5.7, 8.4) for the Flesch-Kincaid Grade Level test, the FORCAST test, and the Gunning-Fog test respectively. Depending on the metric used this meant 58% (95% confidence interval [95% CI] 37 to 78%), 100% (95% CI 85 to 100%) and 71% (49 to 87%) fell outside the 6th Grade reading level recommended by the AMA and NIH.
Conclusions :
Over one half of the PROM questionnaires and instruments commonly used in ophthalmology require a reading comprehension level better than that recommended by the AMA and NIH for patient material. Some PROMSs likely contain questions that are at a level too advanced for most patients to comprehend. Greater care is needed in designing PROMs appropriate for the literacy level of a population.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.