Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results.

OBJECTIVE: To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia. METHODS: A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy. RESULTS: Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period. CONCLUSIONS: MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.

Spectroscopic imaging as a triage test for cervical disease: a prospective multicenter clinical trial.

OBJECTIVE: The objective of the study was to evaluate the potential safety and effectiveness of tissue spectroscopy for the diagnosis of cervical cancer in a prospective multicenter study of women scheduled for colposcopy on the basis of an abnormal Pap test or other risk factor. MATERIALS AND METHODS: Five hundred seventy-two women underwent spectroscopy of the cervix during their colposcopy visit. Spectroscopy measurements taken over a scan period of 4 minutes and 30 seconds were integrated by a cross-validated pattern recognition model and compared with biopsy results to yield sensitivity and specificity of cervical spectroscopy. RESULTS: The median age of subjects enrolled in the study was 27.7 years. The sensitivity of cervical spectroscopy was 95.1% with a corresponding 55.2% specificity for benign lesions. Several potential confounding factors (eg, mucous, blood, patient motion, ambient light) were examined to determine their potential impact on the accuracy of the test. Ambient light seemed to have the greatest effect, but no single factor contributed significantly to the results. The subjects did not experience any adverse events from undergoing the test. CONCLUSIONS: Spectroscopy of the cervix has the potential to accurately detect cervical moderate and high-grade dysplasia while also reducing the false-positive rate for benign cervices. The test is relatively simple to implement and was well accepted by subjects enrolled in the study.

The influence of body mass index on pregnancy outcomes.

OBJECTIVES: To determine antenatal complications, mode of delivery, and birth outcomes for Saint Francis Hospital and Medical Center and Burgdorf Obstetric clinic patient population based on their body mass index (BMI). MATERIAL AND METHODS: This is a retrospective cohort study of 2,270 women who delivered at our institution from 1996 to 2002. Our patient population ranged from ages 23.8 to 26.6 years. The majority of the patients in the study were Black or Hispanic. BMI at delivery was calculated. Maternal data were obtained from our computerized obstetrical database. Exclusion criteria included: nonviable fetus, no recorded maternal height or other incomplete data. For statistical analysis we used a one-way analysis of variance (ANOVA) and a post-hoc Tukey's test, using a computer statistics program (Statmost, Datamost Crop., Salt Lake City, UT), with, P<0.05 considerd significant. RESULTS: This study revealed that those patients with a higher BMI had greater weight gain during pregnancy. Operative delivery rates were also higher with increasing BMI, as was the infant birth weight. Diabetes and hypertension were directly related to the BMI; the higher the BMI the higher their prevalence. The low number of events recorded did not allow a statistical comparison to determine any increase in shoulder dystocia. CONCLUSION: A statistically significant increase in rate of operative delivery, hypertension, diabetes and a trend toward higher birth weight are associated with increased maternal BMI.