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PROMS Beyond Literacy Levels

The readability of most patient-reported outcome measures (PROMs) commonly used in clinical trials and research for ophthalmology, is not appropriate to population literacy levels, according to cross-sectional analysis conducted in the United States.

PROMS are often used in ophthalmic clinical trials because traditional clinical measures, such as visual acuity, are not reflective of a patient’s experience or the impact of disease on their lives.

Data collected PROMS is used to shape policy and manage patients. However, because information contained and questions asked in PROMS are often presented at a reading level beyond the majority of the population, the data collected can be misrepresentative.

Published in British Medical Journal, researchers analysed 40 PROMS previously validated for use in at least one of age-related macular degeneration, glaucoma and/or diabetic retinopathy.

Using readability measures, they set out to determine whether the 40 PROMS had been written to meet a sixth-grade reading level. The American Medical Association (AMA) and National Institutes of Health (NIH) recommend patient materials should not exceed this level.

The median (IQR) readability scores were Flesch-Kincaid Grade Level: 7.9 (5.4-10.5); FORCAST: 9.9 (8.9-10.7) and Gunning-Fog: 8.4 (6.9-11.1). 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.

The authors concluded, “Greater care is needed in designing PROMs appropriate for the literacy level of a population”.


BMJ Open Ophthalmol. 2021 Jun 15;6(1):e000693. doi: 10.1136/bmjophth-2020-000693. eCollection 2021.


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