Center for Health Economics and Management, University Tor Vergata, Rome, Italy.
Clin Ther. 2011 Aug;33(8):1084-1095.e4. doi: 10.1016/j.clinthera.2011.06.012. Epub 2011 Jul 23.
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.
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.
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.
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.
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.
任何人类乳头瘤病毒（HPV）疫苗接种策略的经济评估都需要衡量临床效益（质量调整生命年[QALY]），以反映预期寿命的延长和有效干预措施带来的经济效益。
本初步研究旨在探讨标准化时间权衡（TTO）程序在意大利 HPV 相关疾病所致健康状态效用损失量化中的可行性。
这是一项多中心、回顾性、观察性、横断面研究，旨在从一组经组织学证实为高级别宫颈上皮内瘤变（CIN2-3）的女性中获取效用数据。开发了一种用于计算机化管理 TTO 问卷的算法，以标准化地获取 CIN2-3、肛门生殖器疣和浸润性宫颈癌的健康效用数据。欧洲五维健康量表（EQ-5D）问卷用于评估受访者对自身健康状况的基线感知。采用 Spearman 秩相关系数（ρ）作为有效性的衡量标准，检验效用与年龄、从锥切术到问卷管理的时间以及 EQ-5D 评分之间的相关性。
在纳入的 42 名患者中，有 36 名（85.7%）做出了回应（平均[标准差]年龄为 37.2[9.0]岁）。女性对自身健康状况的感知良好（平均[标准差]EQ-5D 评分 0.93[0.10]）。CIN2-3、肛门生殖器疣和浸润性宫颈癌的平均效用值分别为 0.73（0.22）、0.71（0.35）和 0.02（0.08）。根据ρ值，所考虑的 3 种 HPV 相关疾病均与效用无显著相关性。对于肛门生殖器疣，所获得的效用值存在非显著变异性（范围为 0.54[0.47]至 0.79[0.27]）；这一变异性是本初步研究的局限性，可能是由于样本量有限所致。
根据本初步研究的结果，预计 TTO 标准化程序可行且适用于评估 HPV 相关疾病患者的效用，并适用于意大利宫颈癌预防的成本效益分析。
