CRD/CHE Technology Assessment Group, Centre for Reviews and Dissemination, University of York, York, UK.
Health Technol Assess. 2013 Mar;17(8):1-240, v-vi. doi: 10.3310/hta17080.
Women in England (aged 25-64 years) are invited for cervical screening every 3-5 years to assess for cervical intraepithelial neoplasia (CIN) or cancer. CIN is a term describing abnormal changes in the cells of the cervix, ranging from CIN1 to CIN3, which is precancerous. Colposcopy is used to visualise the cervix. Three adjunctive colposcopy technologies for examination of the cervix have been included in this assessment: Dynamic Spectral Imaging System (DySIS), the LuViva Advanced Cervical Scan and the Niris Imaging System.
To determine the clinical effectiveness and cost-effectiveness of adjunctive colposcopy technologies for examination of the uterine cervix for patients referred for colposcopy through the NHS Cervical Screening Programme.
Sixteen electronic databases [Allied and Complementary Medicine Database (AMED), BIOSIS Previews, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Database of Abstracts of Reviews of Effects (DARE), EMBASE, Health Management Information Consortium (HMIC), Health Technology Assessment (HTA) database; Inspec, Inside Conferences, MEDLINE, NHS Economic Evaluation Database (NHS EED), PASCAL, Science Citation Index Expanded (SCIE) and Science Citation Index (SCI) - Conference Proceedings], and two clinical trial registries [ClinicalTrials.gov and Current Controlled Trials (CCT)] were searched to September-October 2011.
Studies comparing DySIS, LuViva or Niris with conventional colposcopy were sought; a narrative synthesis was undertaken. A decision-analytic model was developed, which measured outcomes in terms of quality-adjusted life-years (QALYs) and costs were evaluated from the perspective of the NHS and Personal Social Services with a time horizon of 50 years.
Six studies were included: two studies of DySIS, one study of LuViva and three studies of Niris. The DySIS studies were well reported and had a low risk of bias; they found higher sensitivity with DySIS (both the DySISmap alone and in combination with colposcopy) than colposcopy alone for identifying CIN2+ disease, although specificity was lower with DySIS. The studies of LuViva and Niris were poorly reported and had limitations, which indicated that their results were subject to a high risk of bias; the results of these studies cannot be considered reliable. The base-case cost-effectiveness analysis suggests that both DySIS treatment options are less costly and more effective than colposcopy alone in the overall weighted population; these results were robust to the ranges tested in the sensitivity analysis. DySISmap alone was more costly and more effective in several of the referral groups but the incremental cost-effectiveness ratio (ICER) was never higher than £1687 per QALY. DySIS plus colposcopy was less costly and more effective in all reasons for referral. Only indicative analyses were carried out on Niris and LuViva and no conclusions could be made on their cost-effectiveness.
The assessment is limited by the available evidence on the new technologies, natural history of the disease area and current treatment patterns.
DySIS, particularly in combination with colposcopy, has higher sensitivity than colposcopy alone. There is no reliable evidence on the clinical effectiveness of LuViva and Niris. DySIS plus colposcopy appears to be less costly and more effective than both the DySISmap alone and colposcopy alone; these results were robust to the sensitivity analyses undertaken. Given the lack of reliable evidence on LuViva and Niris, no conclusions on their potential cost-effectiveness can be drawn. There is some uncertainty about how generalisable these findings will be to the population of women referred for colposcopy in the future, owing to the introduction of the human papillomavirus (HPV) triage test and uptake of the HPV vaccine.
英格兰（年龄在 25-64 岁之间）的女性每 3-5 年接受一次宫颈筛查，以评估宫颈上皮内瘤变（CIN）或癌症。CIN 是描述宫颈细胞异常变化的术语，范围从 CIN1 到 CIN3，这是癌前病变。阴道镜检查用于观察宫颈。为了检查宫颈，已经纳入了三种辅助阴道镜检查技术：动态光谱成像系统（DySIS）、LuViva 高级宫颈扫描和 Niris 成像系统。
确定辅助阴道镜检查技术在 NHS 宫颈癌筛查计划中经阴道镜检查转诊患者的子宫颈检查中的临床效果和成本效益。
16 个电子数据库[辅助和补充医学数据库（AMED）、BIOSIS 预览、 Cochrane 系统评价数据库（CDSR）、Cochrane 对照试验中心注册库（CENTRAL）、护理和联合健康文献累积索引（CINAHL）、疗效评价文摘数据库（DARE）、EMBASE、卫生管理信息联盟（HMIC）、卫生技术评估（HTA）数据库；Inspec、Inside Conferences、MEDLINE、NHS 经济评估数据库（NHS EED）、PASCAL、科学引文索引扩展版（SCIE）和科学引文索引（SCI）-会议录]和两个临床试验注册处[ClinicalTrials.gov 和当前对照试验（CCT）]，检索至 2011 年 9 月至 10 月。
寻找 DySIS、LuViva 或 Niris 与传统阴道镜检查比较的研究；进行叙述性综合分析。开发了一个决策分析模型，该模型根据质量调整生命年（QALYs）衡量结果，从 NHS 和个人社会服务的角度评估成本，时间范围为 50 年。
纳入了 6 项研究：2 项 DySIS 研究、1 项 LuViva 研究和 3 项 Niris 研究。DySIS 研究报告良好，偏倚风险低；他们发现 DySIS（单独的 DySISmap 以及与阴道镜检查联合使用）在识别 CIN2+疾病方面的敏感性高于阴道镜检查单独使用，尽管特异性较低。LuViva 和 Niris 的研究报告不佳，存在局限性，表明其结果存在高度偏倚风险；这些研究的结果不可靠。基本案例成本效益分析表明，在整个加权人群中，DySIS 的两种治疗选择都比阴道镜检查单独使用更具成本效益；这些结果在敏感性分析中进行了测试，结果仍然稳健。在某些转诊组中，DySISmap 单独使用更昂贵且更有效，但增量成本效益比（ICER）从未超过每 QALY1687 英镑。DySIS 加阴道镜检查在所有转诊原因中都更便宜且更有效。仅对 Niris 和 LuViva 进行了指示性分析，因此无法对其成本效益做出结论。
评估受到新技术、疾病领域的自然病史和当前治疗模式的现有证据的限制。
与单独使用阴道镜检查相比，DySIS 尤其是与阴道镜检查联合使用，具有更高的敏感性。目前尚无关于 LuViva 和 Niris 临床效果的可靠证据。DySIS 加阴道镜检查似乎比 DySISmap 单独使用和阴道镜检查单独使用更具成本效益；这些结果在进行的敏感性分析中仍然稳健。由于缺乏关于 LuViva 和 Niris 的可靠证据，因此无法得出关于其潜在成本效益的结论。由于 HPV 筛查试验的引入和 HPV 疫苗的使用，未来对接受阴道镜检查的女性群体的这些发现的推广可能存在一定的不确定性。
