Preliminary research and preparation of outcomes related to pregnancy for developing an NIHR Programme Grant for Applied Research application

Development work questions What are the strengths/limitations of primary care, secondary care and maternity datasets for pregnancy-related research? What clinical outcomes related to pregnancy can and should be measured?

Background There are long standing challenges around accessing whole population pregnancy data from linked electronic health records (EHRs) for research.

This obstructs delivery of high-quality, high-impact research into diverse questions including risks and their management in pregnancy, and how pregnancy modifies the risk of other health exposures, interactions with medications, and more.

The recent Ockenden and Kirkup reviews into shortcomings in maternity care, and challenges in progress against maternal mortality targets, have prompted recent investment and renewed strategic focus on improving care and outcomes during pregnancy.

OpenSAFELY is a secure EHR research platform covering >99% of England with a diverse range of users from over 22 organisations.

Better data management tools to unlock the potential of the pregnancy and pregnancy-related clinical events recorded in this database – and linkage to the Maternity Services Data Set (MSDS) on pregnancy care and delivery – would expand this widely accessible research environment to deliver vital pregnancy-related research.

In our planned Programme Grant we will import the data, create a suite of research variables, describe the data to make it accessible and usable for the wider community, and conduct a programme of initial research projects – in a collaborative group of pregnancy researchers – as pioneer analyses to accelerate work on the same data from the wider community.

Aims To develop a compelling NIHR Programme Grant application that will unlock the potential in under-used EHR pregnancy data for the whole research community.

Objectives Evaluate and describe the pregnancy-related content of MSDS, primary care and secondary care EHR datasets for pregnancy research.

Build a collaborative community of pregnancy researchers and develop pregnancy, postnatal and maternal/child health research questions that play to the strengths of the data. Develop NIHR PGfAR application.

Development work plan Objective 1 - Evaluate MSDS using published metadata, information standards, NHS dashboards and published studies. Evaluate all fields pertaining to pregnancy or delivery in primary and secondary care data in OpenSAFELY. Evaluate published pregnancy register algorithms. Develop a report into the use of EHR data in pregnancy and maternity research.

Objective 2 - Working with our PPIE contributors and academic collaborators, using the findings of Objective 1, identify areas of importance for future outcomes research. Feasibility checks for measuring outcomes in OpenSAFELY with or without MSDS. Develop a suite of research questions for grant.

Objective 3 - Working with collaborators and PPIE group we will develop a detailed and well-evidenced NIHR Programme Grant for Applied Research.

Timelines for delivery Objective 1: 6-8 months Objective 2: 12 months Objective 3: 12 months Anticipated Impact and Dissemination This preparatory work will improve documentation of MSDS, and the potential for using primary/secondary care data in pregnancy research. Our future planned work will unlock the potential in under-used EHR pregnancy data for the whole research community.

We will disseminate via publications, conferences and OpenSAFELY networks.