The objective of this study was to estimate patient compliance with oral and vaginal metronidazole treatment of bacterial vaginosis using personal digital assistants (PDAs) and paper diaries.
The goal of this study was to assess a novel compliance documentation approach.
After each dose of intravaginal or oral metronidazole, 71 subjects recorded the time on a paper diary and answered questions on a PDA. All PDA entries were unknowingly time-date-stamped. Subjects returned for 2- and 6-week posttreatment examinations. Compliance was calculated using a repeated-measures multivariate analysis of variance (ANOVA).
Mean patient compliance rates within the oral metronidazole group were greater with the paper diary compared with the PDA (68.3% and 50.0%, respectively, P = 0.001). The observed rate of compliance agreement for PDA versus paper diary was 69.0% (kappa = 0.4). The majority of noncompliant subjects reported they were compliant with the PDA and paper diary.
PDAs could more accurately document true compliance rates and could be reasonable instruments to assess compliance in intravaginal antimicrobial drug or contraceptive trials.
A study to estimate compliance with oral and vaginal metronidazole treatment of bacterial vaginosis found that personal digital assistants could more accurately represent true compliance rates compared with paper diaries.
From the Departments of *Obstetrics and Gynecology, †Family Medicine, and ‡Office of Biostatistics and Bioinformatics, Medical College of Georgia, Augusta, Georgia
Dr. Ferris has conducted clinical trials, served as a consultant, and received honoraria for speaking at medical education meetings from 3M Pharmaceuticals. The remaining authors have no perceived or potential conflicts.
Austin Lane Technologies, Denton, TX, was contracted to program customized software for the personal digital assistants (PDAs). The authors thank Dr. Sharon Hillier, Director of Reproductive Infectious Disease Research, Department of Obstetrics and Gynecology, Magee Women’s Hospital at the University of Pittsburgh, for performing the Gram stain analyses.
This investigator-initiated study was supported by an unrestricted research grant from 3M Pharmaceuticals, St. Paul, Minnesota.
Correspondence: Daron G. Ferris, MD, Medical College of Georgia, 1423 Harper Street, HH-100, Augusta, GA 30912. E-mail: firstname.lastname@example.org
Received for publication January 12, 2004, and accepted March 10, 2004.