Time trade-off procedure for measuring health utilities loss with human papillomavirus-induced diseases: a multicenter, retrospective, observational pilot study in Italy.

BACKGROUND: The economic evaluation of any human papillomavirus (HPV) vaccination strategy requires the measurement of clinical benefits (quality-adjusted life-years [QALY]) gained to reflect both the increase in life expectancy and the economic benefits associated with an effective intervention. OBJECTIVE: The purpose of this pilot study was to investigate the feasibility of a standardized time trade-off (TTO) procedure to quantify utilities loss in health states affected by HPV-induced pathologies in Italy. METHODS: This multicenter, retrospective, observational, cross-sectional study was designed to elicit data on utilities in a cohort of women with a histologically confirmed diagnosis of high-grade cervical intraepithelial neoplasias (CIN2-3). An algorithm for the computerized administration of a TTO questionnaire was developed for the standardized elicitation of data on health utilities in CIN2-3, anogenital warts, and invasive cervical cancer. The European Quality of Life-5 Dimensions (EQ-5D) questionnaire was used to assess the respondents' baseline perception of their health conditions. The correlation between utilities and age, time from conization to questionnaire administration, and EQ-5D score, was tested using the Spearman rank correlation coefficient (ρ) as a measure of validity. RESULTS: Of 42 enrolled patients, 36 responded (85.7%) (mean [SD] age, 37.2 [9.0] years). The women's perception of their health state was high (mean [SD] EQ-5D score, 0.93 [0.10]). The mean utility values were 0.73 (0.22), 0.71 (0.35), and 0.02 (0.08) for CIN2-3, anogenital warts, and invasive cervical cancer, respectively. Based on ρ values, none of the 3 HPV-induced pathologies considered was significantly correlated with utility. Nonsignificant variability was found among utilities elicited for anogenital warts (range, 0.54 [0.47] to 0.79 [0.27]); this variability was a limitation of this pilot study and was likely the result of the limited sample size. CONCLUSIONS: Based on the findings from this pilot study, a TTO standardized procedure is expected to be feasible and appropriate for assessing utilities in patients affected by HPV-related diseases and for cost-effectiveness analyses of cervical cancer prevention in Italy.

The efficacy of 2002 CDC guidelines in preventing perinatal group B Streptococcal vertical transmission: a prospective study.

OBJECTIVES: The aim of the current study is to evaluate the differences in the rate of perinatal group B streptococcal vertical transmission between women who correctly underwent the CDC 2002 guidelines and women who did not. METHODS: Two study groups: women who correctly underwent the CDC 2002 guidelines (study group 1) and women who did not (study group 2). Intrapartum chemoprophylaxis (IC) was administered to all pregnant women identified as GBS carrier. All newborns received, in the first hour of life, a culture based screening for GBS colonization. RESULTS: One thousand six hundred and sixty nine women were enrolled in the study. The 2002 CDC guidelines were correctly applied in 1273 (76.3%) subjects. There was no early-onset GBS disease. No statistically significant difference in the total number of colonized newborns between study group 1 (4.1%) and study group 2 (3.3%) was found. When the analysis was limited to women with positive GBS screening, a significant difference (P < 0.001) was observed in the number of colonized newborns between mothers who received IC during at least 4 h (group 1; 3.7%) and those who received an IC during less than 4 h (group 1; 12.3%). CONCLUSION: The accurate application of the 2002 CDC guidelines is strongly supported but, to furthermore reduce the risk for GBS colonization and sepsis in the newborns, it appears desirable to identify additional and new prevention strategies.

Pregnancy despite IUD: adverse effects on pregnancy evolution and fetus.

INTRODUCTION: In this retrospective study, we describe cases of pregnancy initiated despite an intrauterine device (IUD), which occurred in our setting in the last 10 years (from January 1992 to December 2001), aiming to point out the effects of IUD in terms of miscarriage or fetal problems. METHODS: Histopathologic reports of IUD pregnancies at any gestational age were found by computer search and analyzed. The characteristics of embryo-fetuses and of decidua-placenta were recorded and compared. RESULTS: Ten IUD pregnancies were found: 3 ended with first-trimester voluntary termination of pregnancy, 2 with second-trimester elective abortions, 2 were miscarried during first trimester (spontaneous abortions) and 3 were carried to term. No relevant abnormalities were found in the development of the embryo-fetuses, except for one case of a newborn with upper lip lesion and a mild deviation of nasal septum. Alterations of the placenta and adnexa were found only in the two miscarriage cases. CONCLUSIONS: The small number of cases found reflects the very low incidence of pregnancies initiated despite an IUD, although an increasing trend has been recorded in the last 5 years, probably concurrently with an increasing immigration flow into our area. Our findings suggest that if the embryo, despite the IUD, can reach a firm attachment during the first weeks of gestation, the pregnancy usually continues to term. It is notable that in this case series a major lip defect occurred in 1 of 10 described cases (10%), suggesting that although pregnancies with IUD are exceptional, fetal abnormalities seem not.