de Carvalho Gomes Helena, Velasco-Garrido Marcial, Busse Reinhard
Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland.
GMS Health Technol Assess. 2005 Dec 29;1:Doc13.
Around 92 million urogenital infections are caused yearly by Chlamydia trachomatis worldwide [1].The overall incidence of sexually transmitted diseases is increasing, as shown by the increases in the number of reported cases of syphilis and gonorrhea [2]. Chlamydia trachomatis infections are associated with various serious diseases in women, men and newborns, which could be, at least partially, avoided by means of early diagnosis and therapy. The Federal Joint Committee - responsible for decision-making concerning the benefit package of the German Social Health Insurance - has publicly announced the starting of deliberations on the issue of screening for Chlamydia trachomatis.
The leading question to be answered is whether screening for Chlamydia trachomatis should be included in the German benefit basket. The aim of this report is to provide a summary of the available evidence concerning the issue of screening for Chlamydia trachomatis.
The summary of published scientific evidence, including HTA reports, systematic reviews, guidelines and primary research is represented. The synthesis follows the structure given by the criteria of Wilson and Jungner [3] for the introduction of screening in a population: relevance of the condition, availability of an adequate test, effectiveness of screening, acceptance of the programme, and economical issues. A literature search was conducted for each aspect of the synthesis and the evidence has been summarised in evidence tables.
We identified five HTA reports from three European agencies [4], [5], [6], [7] and one from the USA [8]. In addition, we identified four guidelines from Northamerica[9], [10], [11], [12] and one from Europe [13]. A total of 56 primary research publications were included: relevance of the disease (n=26), availability of test (n=1), effectiveness of screening (n=11), acceptance of the programme (n=11), economical issues (n=7).
The main limitation of this report is that we relied only on published results. Most of research has been conducted in countries other than Germany. The fulfilment of the criteria for introduction of screening depends on contextual factors. More data from Germany are needed in order to answer the main questions concerning acceptance, use of selection criteria to identify subgroups and economical aspects of screening for Chlamydia trachomatis in Germany.
The criteria for introduction of screening for Chlamydia trachomatis are partially fulfilled. The available evidence indicates that the success of a screening programme for Chlamydia trachomatis will depend on the implementation of strategies for uptake enhancement and probably on the participation of men as well. A pilot project should be conducted in order to assess cost-effectiveness, acceptance and feasibility of different screening strategies in Germany. On the light of the available evidence, the inclusion of screening for Chlamydia trachomatis in the benefit basket without embedding it in a multifaceted programme targeting primary prevention of sexually transmitted diseases and participation in screening cannot be recommende.
全球范围内,每年约有9200万例泌尿生殖系统感染由沙眼衣原体引起[1]。如梅毒和淋病报告病例数的增加所示,性传播疾病的总体发病率正在上升[2]。沙眼衣原体感染与女性、男性及新生儿的多种严重疾病相关,通过早期诊断和治疗可至少部分避免这些疾病。负责德国社会医疗保险福利套餐决策的联邦联合委员会已公开宣布开始就沙眼衣原体筛查问题进行审议。
需要回答的首要问题是沙眼衣原体筛查是否应纳入德国的福利范围。本报告的目的是总结关于沙眼衣原体筛查问题的现有证据。
呈现了已发表的科学证据摘要,包括卫生技术评估(HTA)报告、系统评价、指南及原始研究。综合分析遵循Wilson和Jungner[3]提出的在人群中引入筛查的标准结构:疾病的相关性、合适检测方法的可获得性、筛查的有效性、项目的可接受性以及经济问题。针对综合分析的每个方面进行了文献检索,并将证据总结在证据表中。
我们从三个欧洲机构[4,5,
6,7]和一个美国机构[8]鉴定出五份HTA报告。此外,我们从北美[9,10,11,12]和欧洲[13]鉴定出四份指南。共纳入56篇原始研究出版物:疾病的相关性(n = 26)、检测方法的可获得性(n = 1)、筛查的有效性(n = 11)、项目的可接受性(n = 11)、经济问题(n = 7)。
本报告的主要局限性在于我们仅依赖已发表的结果。大多数研究是在德国以外的国家进行的。引入筛查的标准是否满足取决于具体情况。需要更多来自德国的数据,以便回答关于德国沙眼衣原体筛查的可接受性、用于识别亚组的选择标准的使用以及经济方面的主要问题。
引入沙眼衣原体筛查的标准部分得到满足。现有证据表明,沙眼衣原体筛查项目的成功将取决于增强参与度的策略的实施,可能还取决于男性的参与。应开展一个试点项目,以评估德国不同筛查策略的成本效益、可接受性和可行性。鉴于现有证据,不建议在未将其纳入针对性传播疾病一级预防和筛查参与的多方面项目的情况下,将沙眼衣原体筛查纳入福利范围。