Expert consensus on pre-eclampsia risk screening tools for low- and middle-income countries: Development of a new Target Product Profile.

Risk screening tools can identify women at high-risk for developing pre-eclampsia, allowing for timely preventative care and monitoring. However, tools that are accurate, feasible and affordable for limited-resource settings are lacking. Target Product Profiles (TPPs) define the minimum and optimal criteria required for new products to achieve a specific health need. Through the Accelerating Innovation for Mothers (AIM) project, we developed the first TPP for pre-eclampsia risk screening tools, suitable for use in low- and middle-income countries (LMICs). We used a mixed-methods approach, including stakeholder interviews, an online multilingual survey, and public consultation to inform the draft TPP. Diverse stakeholders (e.g., clinicians, manufacturers, researchers) representing all WHO geographical regions were invited to participate. We used descriptive statistics to identify variables that met consensus (≥75% agree or strongly agree) from surveys and qualitative content analysis to identify emerging themes from interviews. We conducted 26 interviews and received 84 survey responses, from diverse participants in terms of geographies, gender and country income level. Consensus was reached on all but two of the 25 TPP variables (tool recommendations, sample collection). Following interview feedback, we modified the TPP to include three distinct sections (biophysical, biochemical and digital), allowing these tool types to be clearly defined. This is the first TPP on risk screening tools for predicting pre-eclampsia. This will facilitate the development, evaluation and advancement of pre-eclampsia risk screening tools for pregnant women. It can help ensure these tools address real-world needs and current gaps in pre-eclampsia related care in LMICs.