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EUthyroid Report Summary

Project ID: 634453
Funded under: H2020-EU.3.1.2.

Periodic Reporting for period 1 - EUthyroid (Towards the elimination of iodine deficiency and preventable thyroid-related diseases in Europe)

Reporting period: 2015-06-01 to 2016-11-30

Summary of the context and overall objectives of the project

Iodine deficiency is the world’s leading cause of preventable brain damage and for years the World Health Organization has warned that Europeans are increasingly affected by the consequences of iodine deficiency. Europe currently has no harmonised approach to ensure that the iodine intake of European citizens is sufficient to prevent health problems. EUthyroid is an EU-funded research project to evaluate current national efforts aimed at preventing iodine deficiency disorders (IDD). By the analysis of current national approaches, assembling critical mass and creating capacities for harmonised monitoring of iodine intake we aim to pave the way for improved and cost-effective strategies to ensure a euthyroid Europe in cooperation with national authorities. The pan-European study has initiated an evaluation of existing IDD prevention programmes by collating and analysing data from disease registries in at least 19 of the 27 countries participating in EUthyroid. The pooled data in a joint database will result in the first valid map of comparable data about iodine status in Europe.

EUthyroid supports harmonisation of national and regional surveys of iodine supply and thyroid disorders in up to 45 studies from 24 countries, through the provision of standardised questionnaires, guidelines and training tools, and for the first time, provides standardised thyroid-related measurements yielding a reliable view of the current status of iodine-related disorders in Europe. The project explores the potential of thyroglobulin as a marker for the individual iodine status according to WHO recommendations with a focus on pregnant women and women of reproductive age, two key target groups for IDD prevention due to the high risk of adverse effects on cognition of babies exposed to moderate iodine deficiency. This research is supposed to contribute to a new international recommended thyroglobulin (Tg) reference range for pregnant women and women of reproductive age. Importantly, EUthyroid studies the consequences of maternal iodine status during pregnancy in relation to the cognitive development of their children (as measured by child IQ, autism, ADHD and language development) using retrospective data from three countries (Spain, UK and the Netherlands). In order to be able to support decision-making processes in the healthcare system, the project partners aim with results from a developed decision-analytic model to explore the long-term effectiveness and cost-effectiveness of prevention and monitoring strategies for iodine deficiency disorders. Furthermore, EUthyroid follows through on an ambitious dissemination strategy to engage actively policy makers, stakeholders and the general public to promote harmonised IDD prevention and monitoring in European countries.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first reporting period, the consortium successfully established a joint European database for registry data related to the occurrence of thyroid diseases in European countries. The database currently also collates data from 24 IDD monitoring studies from 13 countries participating in EUthyroid. The EUthyroid infrastructure was established and includes a range of resources and training tools to support the harmonisation of studies including: socio-economic status (SES) questionnaires for adults and children; an instructional video on thyroid ultrasound examination and a web-based training and certification tool (ARCUS) for ultrasound observers. All training tools are accessible through the project´s website.

Additionally, EUthyroid has developed a dried blood spot (DBS) Tg ELISA assay to analyse DBS cards of pregnant women and women of reproductive age (WRA) collected from various IDD monitoring studies across Europe, and to further cross-validate a reference range. Moreover, an intra-individual variation in DBS Tg study in 25 healthy adults has been conducted and finalised, the collected serum and DBS samples will be analysed to assess intra-individual variation and variation between the analysis methods.

Data from the Netherlands, UK and Spain have been brought together, harmonised and integrated into one large dataset that will enable us to study the effects of low maternal iodine on child neurodevelopment using large numbers while also taking into account differences between the countries. The dataset includes data on almost 9,000 pregnant women with 3,000 additional urinary iodine measurements obtained.

A proof-of-principle study has been performed on the effects of thyroid function on child IQ and the risk of behavioural disorders in over 9,500 mothers and their children. Results showed that both low and high maternal thyroid hormone levels during early pregnancy are associated with a lower child IQ and a higher risk of autism.

In order to provide evidence for IDD prevention and monitoring programmes in Europe a preliminary model structure of a decision-analytic model was developed and expert input and systematic literature searches undertaken to parameterise the model.

Policy makers, stakeholders and the general public have been targeted through a range of media including a project website, conference presentations, articles in national press and television interviews. Regional monitors have identified and contacted relevant national health authorities towards bringing about policy change in Europe.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

EUthyroid aims to progress beyond the state of the art of fragmented national strategies towards iodine deficiency prevention through the harmonisation of: existing registry data; guidelines for study conduction; training of study staff and measurement of samples. At the EUthyroid policy meeting, which took place in Brussels in April 2016, it was clearly stated that the EC will not harmonise national legislation, therefore the focus shifts to working towards voluntarily harmonised national activities to provide the project's impact.

This is effectively underpinned by
• a joint European database for registry data and standardised IDD monitoring studies using geocoding to improve comparability and promote the first European map of iodine status and thyroid disease load.
• resources and training tools to support harmonisation of studies
• a new DBS Tg assay facilitating sample collection, storage and handling

EUthyroid is currently engaged in coordinating national monitors from 24 European countries to support 45 IDD monitoring studies, which will yield comparable data for individual iodine status, using urinary iodine concentration (UIC). This will provide the most in-depth analysis of iodine deficiency and health outcomes in a moderate and mild iodine deficient region and provide a sound foundation of data to fill the current lack of health outcome research, which is considered the major stumbling block to initiate national monitoring studies.

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