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Institute of Epidemiology & Health Care

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Study of regulatory communication and risk awareness

Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism

Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism

Funded by the European Medicines Agency (EMA) as part of a European consortium with Fiona Stevenson as the lead for this project

Start date late Spring 2016 for 18 months

Research has demonstrated an increased risk of venous thromboembolism (VTE) in women using combined hormonal contraceptives (CHCs) compared with non-users who are not pregnant. The project will investigate the awareness of both regulatory communication and risk among doctors, users and non-users of CHC products following the implementation of actions arising from the 2013 review of CHC in relation to venous thromboembolism. This will be done across a range of European Union Member States. The work will establish ways in which the recent experiences and views of users and potential users of CHCs and health care professionals can be used to improve regulatory communications in the future.

Overall study design

A mixed methods approach will be used. The fieldwork will comprise in-depth interviews with woman of reproductive age and health professionals, informed by an initial internet search to assess the amount and types of information available online when searching for side effects of CHCs and more specifically for information relating to the risk of thromboembolism. These findings will then be used to develop a survey in electronic format for health professionals, which will be distributed via our European Primary Care Networks across a number of European Union Member States. A survey in electronic format will also be sent to users and potential users of CHCs. It will be distributed both via our established Primary Care Networks and also via social media such as Facebook and Twitter, which direct women via a link to information and following consent, the survey.

An advisory panel including women and health care practitioners will be convened to help guide the fieldwork.