Patient-reported outcome measures in ophthalmology: too difficult to read?

OBJECTIVE: Patient-reported outcome measures (PROMs) are commonly used in clinical trials and research. Yet, in order to be effective, a PROM needs to be understandable to respondents. The aim of this cross-sectional analysis was to assess reading level of PROMs validated for use in common eye conditions. METHODS AND ANALYSIS: Readability measures determine the level of education a person is expected to have attained to be able to read a passage of text; this was calculated using the Flesch-Kincaid Grade Level, FORCAST and Gunning-Fog tests within readability calculations software package Oleander Readability Studio 2012.1. Forty PROMs, previously validated for use in at least one of age-related macular degeneration, glaucoma and/or diabetic retinopathy, were identified for inclusion via a systematic literature search. The American Medical Association (AMA) and National Institutes of Health (NIH) recommend patient materials should not exceed a sixth-grade reading level. Number of PROMs exceeding this level was calculated. RESULTS: Median (IQR) readability scores were 7.9 (5.4–10.5), 9.9 (8.9–10.7) and 8.4 (6.9–11.1) for Flesch-Kincaid Grade Level, FORCAST and Gunning-Fog test, respectively. Depending on metric used, this meant 61% (95% CI 45% to 76%), 100% (95% CI 91% to 100%) and 80% (95% CI 65% to 91%) exceeded the recommended threshold. CONCLUSION: Most PROMs commonly used in ophthalmology require a higher reading level than that recommended by the AMA and NIH and likely contain questions that are too difficult for many patients to read. Greater care is needed in designing PROMs appropriate for the literacy level of a population.