Over-the-counter ovulation prediction devices: do accompanying instructions adhere to low-literacy guidelines?

To evaluate readability and layout features of English-language instructions accompanying brandname urinary- and salivary-based over-the-counter (OTC) ovulation prediction devices (OPDs).

We identified and purchased 6 urinary-based and 4 salivary-based OTC OPDs. McLaughlin's Simplified Measure of Gobbledygoop was used to calculate reading grade level, and prominent text point size was measured throughout the instructions. Total number and dimensions of illustrations were tallied. We also assessed layout features derived from the User-Friendliness Tool (UFT), including layout features, graphic characteristics, presence of a clear message and presentation of manageable information.

Overall reading level of OTC OPD instructions ranged from 8th to 12th grade (mean +/- SD = 10.2 +/- 1.3). Mean page length was 29.0 +/- 12.8 cm, while average page width was 30.7 +/- 14.7 cm. Average text point size was 8.2 +/- 1.5 (range, 6-10). Illustrations were used throughout instructional materials (range, 5-10). None of the instructions scored high in all criteria on the UFT.

Most OTC OPD instructions are written above the recommended sixth grade level and lower, printed in a font size smaller than suggested and illustrated inadequately to foster successful patient education.