Epidemiologic differentiation of diagnostic and screening populations for the assessment of cervical dysplasia using optical technologies.

BACKGROUND

We report here the logistic modeling of the epidemiologic differences between a diagnostic population and a screening population recruited for the study of optical technologies for cervical cancer detection.

OBJECTIVES

The goal of this analysis was to determine if there were differences in the sociodemographic or clinical factors between subjects recruited to our diagnostic and screening trials.

METHODS

Epidemiologic data were obtained from a risk factor interview as a component of a multicenter Phase II clinical trial that used fluorescence and reflectance point spectroscopy to diagnose cervical disease. Participants with recent or past abnormal findings on a Papanicolaou smear were grouped into the diagnostic (high-risk) population, whereas those with a history of normal findings on Papanicolaou smears and no cervical treatments were grouped into the screening (low-risk) population.

RESULTS

Our model revealed that nonwhite race, higher than a high school education, and peri- and postmenopausal status were associated with the screening population. A history of genital infections, current oral contraceptive use, human papillomavirus positivity (by Hybrid Capture II and consensus polymerase chain reaction), and worst histological diagnosis at clinic visit were important predictors of being in the diagnostic group.

CONCLUSIONS

We were successful in recruiting 2 distinctive populations and anticipate being able to use these results to more correctly classify women at higher risk for cervical lesions in our future studies of optical spectroscopy.