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The impact of inaccurate reporting of condom use and imperfect
diagnosis of sexually transmitted disease infection in studies of condom
effectiveness: a simulation-based assessment.
Sexually Transmitted Diseases 2004;31(10):588-595.
Devine OJ, Aral SO.
Abstract
BACKGROUND AND OBJECTIVES: The effectiveness of condoms in reducing sexually
transmitted disease (STD) infection risk has been debated in the face of
equivocal epidemiologic evidence. We assessed the potential magnitude of
bias in condom effectiveness studies resulting from inaccurate reporting
of condom use behavior and misdiagnosis of STD infection status. GOAL: The
goal of this study was to illustrate the magnitude of bias in condom effectiveness
studies in the presence of inaccurate condom use reporting and diagnostic
misclassification. STUDY: We used probabilistic simulations to mimic plausible
outcomes for hypothetical prospective and retrospective condom effectiveness
studies subject to both inaccurate reporting of the participants' true condom
use and diagnostic error. The simulations were conducted by generating a
series of binomial (yes, no) random variables corresponding with STD infection
status and accurate diagnosis of infection. RESULTS: The simulation results
illustrate that failure to address reporting and diagnostic errors can lead
to a substantial bias in studies of condom effectiveness. This bias resulted
in a roughly 25% to 30% reduction in the probability of detecting a true
2-fold reduction of infection risk resulting from using condoms. CONCLUSION:
Inaccurate reporting of condom use and reliance on imperfect diagnostic tests
can substantially bias observable measures of condom effectiveness. The potential
for these biases should be addressed in the design and analysis of effectiveness
studies.