Working towards better informed consent: service user-led exploration of women's views on data linkage on behalf of their unborn child[ren]

This paper outlines how service user co-investigators worked towards achieving informed consent to data linkage in a large-scale clinical trial in pregnancy with long-term developmental outcomes.The PANDA (Primary prevention of maternal ANaemia to avoid preterm Delivery and other Adverse outcomes) programme is testing whether prevention of anaemia during pregnancy reduces adverse clinical complications such as preterm birth and low birth weight. One component is a randomised trial of 11,000 women taking oral iron from early in pregnancy versus placebo. Collection of infant and childhood data by linkage to relevant national datasets will enable efficient and robust assessment of key long-term developmental outcomes. Faced with the challenge of informing women’s consent, service user investigators have been proactive and adaptive in leading the development of women-facing materials.Initially, service user co-investigators consulted women to determine the breadth of issues important to them when considering consenting to PANDA. Then, they produced draft materials tailored to women’s information needs, prioritising information accessibility. Subsequently, they lobbied for, and led, additional focus groups with women from PANDA’s pilot trial to seek feedback on the bespoke materials and gauge the extent to which women understood the content and issues being expressed.