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Content archived on 2024-04-30

European multicentre examination of congenital toxoplasmosis

Objective

Objectives:
There is no consensus on the most effective screening algorithm for toxoplasma infection in pregnancy due to the lack of systematic evaluation of different programmes. Diverse strategies currently operate in Europe with widely varying costs. The aim of the proposed study is to:
- quantify the risk of symptomatic congenital toxoplasmosis associated with early, delayed or no prenatal anti-toxoplasma treatment;
- compare the clinical effectiveness of screening algorithms and provide a framework for cost effectiveness analyses in different health care settings.

Pollcy makers are divided on the issue of serological screening to prevent congenital toxplasmosis. In some countries there is an explicit policy not to offer screening, while in others, regular prenatal tests form anintrinsic part of routine obstetric management. Furthermore, due to the lack of systematic evaluation of the different programmes there is no consensus on the most effective screening algorithm or treatment regimen. This diversity of preventive strategies for congenital toxoplasmosis reflects the lack of sound evidence for the clinical effectiveness of screening. Neither has a comprehensive analysis of the costs of screening been undertaken, although these are likely to be considerable: crude estimates of the costs for serological testing alone for 770,000 pregnant women (the number per year in France or the UK), range from 42 million ECU for prenatal screening with monthly re-testing in France, to 4 million ECU for neonatal screening (based on Danish costs).

The proposal has two main objectives:
1. To quantify the risk of symptomatic congenital toxoplasmosis associated with early, delayed or no prenatalanti-toxoplasma treatment based on data derived from the multicentre study of women infected during pregnancy and their children;
2. To develop a decision analytic model to compare the clinical effectiveness of screening algorithms and provide a framework for cost effectiveness analyses indifferent health care settings The proposal builds on concerted action BMH4-CT95-1688 which aimed to create a network of clinicians willing to participate in a multicentre collaborative study. This objective has been successfully achieved ahead of schedule and recruitment from 13 centres in 7 countries will begin in January 1997 according to a standard protocol.

The study is planned to run for 3 years in the first instance and will enrol around 1200 mothers and their children. The study has been carefully designed to avoid the selection biases that have limited many epidemiological studies in the past. It is also proposed to develop, in collaboration with clinical experts, decision analytic models for a range of feasible screening and treatment algorithms. These models, using core inputs from the cohort study, will form the basis for a clinical effectiveness analysis of different screening algorithms. The model will then be used to provide a framework for local decision making by clinicians and policy makers by the modification of regionally variable parameters, such as health care costs, risks of exposure to infection and values of pregnant women regarding the outcomes of screening. The proposal relates most closely to Research Task 6.2 ("evaluation of the effectiveness of prevention strategies") but is also connected to Research Tasks 6.6 ("identify new emerging technologies and to assess their effectiveness"), and 6.7 (`major comparative population-based studies of interventions').

Keywords: screening, public health, clinical effectiveness, toxoplasmosis, pregnancy. 02 02

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CON - Coordination of research actions

Coordinator

University College London
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30,Guilford Street
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