The role of an over-the-counter vaginal pH self-test device package insert: can subjects learn what the device is for and how to use it?

Abstract

Objective: This study was undertaken to determine whether subjects could read and understand the package insert of a vaginal pH self-test device to improve self-diagnostic accuracy.

Study design: This study was performed at 8 clinic locations with 206 women of varying ages, ethnicity, and education. A package insert explaining the indications and clinical facts associated with the use of a vaginal pH self-test device was used. A 16-item questionnaire was administered to assess comprehension.

Results: The cumulative probability of having 12 or more correct answers of 16 was P = .038, significantly different than by chance alone, representing 200 (97.1%) of subjects in this trial.

Conclusion: The package insert for the vaginal pH self-test device was read and understood by subjects. Indeed, they correctly understood the role of vaginal pH as an aid in the diagnosis of vaginal symptoms while improving decisions to use an over-the-counter antifungal medication or to see a health care provider.