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?
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.


METHODS
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.


CONCLUSIONS
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.
Roy
S
S
Obstetrics and Gynecology, Keck School of Medicine of the University of South California, Women's and Children's Hospital, Los Angeles, CA 90033, USA. subirro@usc.edu
Caillouette
J C
JC
Faden
J S
JS
Roy
T
T
D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage*; D002140:California; D004348:Drug Labeling; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D004366:Nonprescription Drugs; D010353:Patient Education as Topic; D011795:Surveys and Questionnaires; D014621:Vagina / Q000503:physiopathology*; D014848:Vulvovaginitis / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology
D000935:Antifungal Agents; D004366:Nonprescription Drugs