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.

Sexual behaviour in Ligurian (Northern Italy) adolescents and young people: suggestions for HPV vaccination policies.

Human papillomavirus is a common sexually transmitted virus, and persistent infection with high-risk types is the necessary factor for cervical cancer. We investigated sexual behaviour and the age of the first sexual intercourse among young people (14-24 years) in Liguria (Northern Italy) in order to provide information that might orient the country's future vaccination policy. The Italian Authorities offer free vaccination to 12-year-old females, however a better prevention of HPV would to be implemented by introducing the vaccine to new cohorts of females after the first year of the vaccination campaign. Our survey was carried out from 1st May 2006 to 31st December 2007 and involved 3474 volunteers. We administered a written questionnaire to students (14-24 years) and workers (20-24 years). The median age+/-MAD of the sexual debut was 15+/-1 for both females and males in students group and 16+/-1 for both males and females in workers group. This study provides evidence that many Ligurian adolescents have their first sexual experience at a very early age, and often without protection against sexually transmitted diseases. Furthermore, a large percentage of all age-groups are sexually active and have multiple partners. The aim of this study was to identify those cohorts of females to whom vaccination should be offered free of charge. To this end, we calculated the percentage of infections that could be avoided by vaccination in each age-class: the younger the subjects, the higher the number of preventable infections. Our findings suggest that current HPV vaccination should be implemented by introducing new cohorts, especially young girls (14-16 years).