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Personal digital assistants used to document compliance of bacterial vaginosis treatment.

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Abstract

OBJECTIVE

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.

GOAL

The goal of this study was to assess a novel compliance documentation approach.

STUDY

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).

RESULTS

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.

CONCLUSIONS

PDAs could more accurately document true compliance rates and could be reasonable instruments to assess compliance in intravaginal antimicrobial drug or contraceptive trials.

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