“This test has improved our ability to make the right decision on admission. The right patients are being discharged, leaving us to focus on those women who are at greater risk of developing pre-eclampsia.”
Dr Sofia Cerdeira, obstetrician and research leader, Oxford University Hospitals
Overview

Quick, accurate blood tests which can help rule out pre-eclampsia are contributing to safer pregnancies and better outcomes for tens of thousands of pregnant women and their unborn babies. More accurate diagnosis reduces the need for admission and enables a clearer focus on women needing closer monitoring. The pandemic has underlined the importance of safe and effective care, and minimising unnecessary hospital admissions. Within four years of the first real world evaluation in the Oxford AHSN region, 119 of England’s maternity units (two-thirds of the total) have adopted the test into standard clinical practice following a rapid adoption project led by AHSNs. This is a successful example of AHSNs understanding the challenges to adopting new technology and helping the NHS and innovators work together to overcome them.

Challenge / problem identified

Pre-eclampsia (PE) is a multi-system hypertensive disorder – a serious disease that occurs in around four per cent of all pregnancies (about 23,000 annual cases in the UK). It causes high blood pressure, protein in the urine and oedema and can result in maternal organ failure, restricted foetal growth and pre-term delivery. In extreme cases it can lead to foetal or maternal death. Clinical teams inevitably have a high degree of suspicion for the disease and a low threshold to admit pregnant women with suspected PE. This places significant economic and capacity burdens on maternity systems. It costs the NHS an estimated £9,000 per pregnancy to treat. Up to now there has been no definitive way to accurately diagnose who is not at risk of developing pre-eclampsia. Women are routinely admitted for an anxious few days of hospital tests ‘just in case’ – but most do not actually have the condition.

How is the AHSN involved?

In 2017, the Oxford AHSN initiated a project to increase uptake and adoption of placental growth factor-based (PlGF) testing which highlights women who are likely to develop pre-eclampsia within 7-14 days. The blood test can be taken as part of routine checks at between 20 weeks and 34 weeks plus 6 days of pregnancy in line with NICE guidance. The test supports clinical decision-making by providing an objective measurement to combine with other clinical symptoms, such as high blood pressure, blurred vision or high protein in urine.

Working with the Oxford Patient Safety Collaborative and clinical leads, laboratory heads, finance and management functions, the Oxford AHSN helped three of the first hospitals in England to adopt PlGF-based testing into standard clinical practice.

This successfully demonstrated that by offering tests to women suspected of having pre-eclampsia clinical teams were better able to identify women who did not have the disease and could safely be sent home, avoiding unnecessary hospital admissions for monitoring. It provided a platform for wider spread and adoption – both within and beyond the Oxford AHSN region. The Oxford AHSN developed an implementation pack to support this work. This supports a collaborative, multi-disciplinary approach including changes required to pathways and practices. For each maternity unit AHSNs are developing insight into their unique pathway and needs and providing project management and business support behind the adoption process.

The test was selected for the NHS England Accelerated Access Collaborative, Innovation Technology Payment and Rapid Uptake programmes which introduce an accelerated pathway to market for highly transformative innovations. From April 2019 providers of maternity services were able to adopt and implement either the Quidel Triage PlGF test or the Roche Elecsys sFlt-1:PlGF ratio test fully funded, as NHS England centrally reimbursed the suppliers directly.

All AHSNs, led by the Oxford AHSN, have been working together to ensure rapid and widespread adoption of the test into standard clinical practice in maternity units across the country. By February 2021 more than 100 maternity services had adopted this test. In 2020/21 more than 40,000 women benefited from the test. Projected annual savings in England are estimated at £4m per year relating to reduced hospital bed occupancy.

In March 2021 the Oxford AHSN delivered a workshop on overcoming barriers to adopting placental growth factor testing as part of Bridging the Gap, an AHSN Network event offering insights and guidance to healthcare industry innovators. From April 2021 PlGF-based testing is one of four technologies included under the new NHS MedTech Funding Mandate.

The Oxford AHSN’s pre-eclampsia work secured two prizes in 2019: an HSJ Partnership Award and a Univants of Healthcare Excellence Award. It was also a finalist in the HSJ Awards.

Impacts / outcomes of AHSN involvement to date

AHSNs are leading a rapid roll out into maternity units across the country enabling faster and more accurate diagnosis. This is making the pre-eclampsia test available to thousands more pregnant women – up from 29,000 in March 2019 to a predicted 200,000+ by the end of December 2019.

Detailed implementation packs have been developed covering changes required to pathways and practices. These make it relatively straightforward to replicate at any maternity unit which is supported by a laboratory.

A collaborative, multi-disciplinary approach is enabling improved decision-making, clinical risk reduction and better targeting of resources. This in turn is leading to improvements to patient safety, experience and satisfaction.

For each hospital AHSNs are developing insight into their unique pathway and needs and providing project management and business support behind the adoption process.

Positive impacts include:

  • Improved patient safety through accurate diagnosis on the suspicion of PE
  • Reduction in the number of (unnecessary) admissions for suspected PE
  • Improvement in maternity capacity as the result of having fewer women to monitor as inpatients
  • Improvement in community midwifery capacity due to a reduction in the number of follow-on appointments required once PE is suspected
  • A reduction in the direct costs to the system from the array of inpatient monitoring tests undertaken on the woman and her foetus. Of note is the ability to keep a woman on the most appropriate treatment pathway (i.e. Standard, Intermediate or Intensive) and not to have to escalate the level of her care to a higher pathway during the pregnancy upon the suspicion of PE, for which no additional funds are made available
  • A reduction in the number of pre-term or emergency deliveries (delivery of the baby is the only “cure” for PE)
  • Positive impact on workload and costs incurred by both maternity and paediatric services as a result of fewer pre-term births – cost savings based on fewer outpatient visits, admissions, pre-term deliveries and less onward neonatal care – projected savings in England are expected to be in the region of £4m per year, based on an estimated saving of £250-£600 per woman tested projected from health economic models.

There is also growing international interest in adopting this model; clinical and laboratory leaders from the original UK adopting Trust are providing support to adopting hospitals abroad.

This NHS/research/industry partnership has won national and international awards, including from the HSJ and the UNIVANTS of Healthcare Excellence.

Through the work with Oxford AHSN on this and other projects, Roche Diagnostics also estimate that around 6 jobs have been safeguarded across England.

Learning to date

Key to the success of the project is confirmation of local clinical need, drivers and priorities in each hospital, mapping current and future clinical pathways with associated costs and benefits.

To successfully deliver the project, key internal stakeholders (e.g. labs, finance) who are required to approve and then implement the adoption of the new test and pathway have to be identified and engaged early on in the process.

As with most diagnostic tests, simply adopting the test into existing clinical or patient pathways will likely add cost with limited additional benefit for the clinical team or pregnant women under their care. As such, clinical and laboratory teams must adopt new pathways to incorporate PlGF-based testing into standard clinical care. Example pathways are available through the AHSN Network.

In July 2021 the Oxford AHSN and Sustainable Healthcare Coalition published a report highlighting how PlGF-based testing for pre-eclampsia has additional environmental benefits. In addition to the benefits of widespread PlGF testing outlined above, it concluded that the consequent cut in patient journeys and overnight hospital stays could potentially save 1,149 tonnes CO2e – equivalent to three million miles of car travel each year in England.

Plans / timescales for adoption and spread

Having worked through the Oxford Patient Safety Collaborative to achieve initial adoption in three maternity units in the Oxford AHSN region, PlGF-based testing to aid in the diagnosis of suspected pre-eclampsia was selected for funding under both the Innovation Technology Payment (ITP) and Rapid Uptake Product (RUP) payment schemes under the Accelerated Access Collaborative (AAC) in April 2019. The project is now being delivered nationally by all 15 AHSNs, led by Oxford AHSN.

Maternity services have responded very positively to the adoption of PlGF-based testing. In the first nine months of ITP funding, it anticipated that around 50 additional NHS trusts will have adopted a test into standard clinical practice, meaning over 200,000 additional pregnant women will have a diagnostic test for PE available to them (up from 29,000 across five adopted Trusts prior to April 2019). These numbers mean that just over 40% of all maternity services in England are expected to have adopted a PlGF-based test by year end, covering just over a third of all pregnancies.

Opportunities to get involved

Please contact Oxford AHSN via the contact details below or your local AHSN.

Start and end dates

2017-2021.

Project contact for further information

Guy Checketts, Head of Transformation

E: guy.checketts@oxfordahsn.org

Media contact for further information

Rochelle Nelson, Project Manager- Digital Marketing

E: Rochelle.nelson@oxfordahsn.org