INTRODUCTION: 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. RESEARCH QUESTIONS: 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. METHODS: 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. RESULTS: 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). DISCUSSION: 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. CONCLUSIONS: 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.
INTRODUCTION: 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. RESEARCH QUESTIONS: 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. METHODS: 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. RESULTS: 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). DISCUSSION: 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. CONCLUSIONS: 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.
Entities:
Keywords:
chlamydia trachomatis infection; infection; mass screening; screening programme; urethritis
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. Mucopurulent cervicitis and ascendant pelvic inflammatory disease (PID) in women are frequently caused by Chlamydia trachomatis and Neisseria gonorrhoea. It has been estimated that about 20% of women suffering of PID will develop infertility, about 20% will develop chronic abdominal pain, and if they get pregnant 10% will suffer an ectopic pregnancy (EP) [16]. Men usually develop asymptomatic infections, however Chlamydia trachomatis infection can present as urethritis. Infection during pregnancy can cause premature rupture of membranes and contractions leading to premature birth. Vertical transmission during delivery is also possible and can cause conjunctivitis and atypical pneumonia in the newborn.In Germany, screening for Chlamydia trachomatis infection is done as part of the follow-up of pregnancy. 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.
2. Research Questions
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 following questions are posed:
Relevance of the condition
What are the prevalence and incidence of Chlamydia trachomatis infections in Germany?What is the burden of diseases caused by Chlamydia trachomatis?What is known about the natural course of Chlamydia trachomatis infections (i.e. risk of reinfection)?
Availability of adequate test
Which tests are the most appropriate to be used in the context of screening?
Effectiveness of screening
Can a reduction of the incidence of Chlamydia trachomatis infections be achieved after the introduction of screening?Can a reduction of the incidence of infertility, PID, EP, premature births and neonatal infections be achieved as a consequence of screening?Which one is the most effective screening strategy?Which selection criteria can be used to identify subgroups at high risk?
Economic issues
What is the cost-effectiveness of screening for Chlamydia trachomatis infections?
3. Methods
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] or 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 in MEDLINE, EMBASE and The Cochrane Library. In addition the publication catalogues of the members of the International Network of Agencies for Health Technology Assessment were searched, in order to identify available HTA reports.We excluded:Publications dealing with populations in low income countries in Asia, Africa and AmericasStudies dealing only with very high risk groups (e.g. sex-workers, drug consumers, prisoners)Publications reporting basic research (e.g. microbiological characteristics)Publications of single clinical cases or expert opinionsThe evidence has been summarized in narrative form and presented in evidence tables.
4. Results
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 best available evidence indicates a prevalence of Chlamydia trachomatis infections in the German population of about 5%. However the prevalence in the group of persons under 25 years might be about 8%. These figures are lower as the ones reported for the countries were screening has been recommended. There is a lack of data to assess the rate of Chlamydia trachomatis associated diseases in Germany. Thus, it is not possible to judge the relevance of the condition for the German context. The natural course of the disease is not yet fully understood. This sexually transmitted infection can be effectively treated with antibiotics, in order to avoid further transmission and in the expectation of preventing associated diseases. However, some of these diseases (e.g. PID, infertility) are not specifically linked to Chlamydia trachomatis but also to other sexually transmitted infections.The available evidence shows that the most sensitive test are the ones based on DNA-amplification such as ligase chain reaction (LCR) and polimerase chain reaction (PCR). In addition, these tests allow for self-collection of sample (urine and vaginal secret), making unnecessary the presence of medical personal for urethral or cervical sample collection.The available evidence shows that the implementation of screening for Chlamydia trachomatis can lead to a reduction in the incidence rate of PID. Consequently, a reduction in the incidence of infertility and EP can be expected too. The facilitation of the access to the test (i.e. possibility of home-based self-collection, possibility of mail-based test-delivery) yield better screening uptake rates as the sole information on the availability of the test. The available evidence shows, that both men and women should participate on screening, in order to achieve better population results.Selection criteria should help to identify persons at high risk and target screening to a subgroup of the population. Different sets of selection criteria have been described in the literature, however they are context-specific and thus not applicable in Germany.The available economic evaluations of screening for Chlamydia trachomatis point out the cost-effectiveness of the intervention under the conditions of prevalence >4% and high screening uptake.
5. Discussion
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.
6. Conclusions
The criteria for introduction of screening for Chlamydia trachomatis are partially fulfilled.The prevalence of the infection probably lays between 1% and 5.4% in the general German population. Higher prevalence rates can be expected among young people (however there is much room for uncertainty in the data). The infection may lead to serious diseases, however there is a lack of valid data concerning the burden of disease caused by Chlamydia trachomatis (from the perspective of the German society).There are several tests available which allow an accurate and non-invasive detection of the infection. In addition antibiotic treatment is effective in the eradication of Chlamydia trachomatis. However, eradication therapy does not ensure prevention of long-term consequences of the infection, since the pathological changes underlying them might already be present at the moment of screening (e.g. tubaric inflammation). Re-infection poses another problem.Screening of women or of women and men can lead to a reduction of the incidence of PID.Under some conditions (e.g. nearly full participation of the target population in screening), screening might be cost-effective, however there is much uncertainty in the available evidence.The inclusion of screening for Chlamydia trachomatis in the benefit basket as part of the preventive measures (according to Social Code Book V) limitating it to screening exclusively women is questionable. 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.There is a need for an evaluation of the cost-effectiveness, acceptance and feasibility of different screening strategies in Germany, for example in the form of a pilot project. 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 recommended.