Impact case study database

King’s-led research has informed national and international policy and guidelines on high risk pregnancy, thereby influencing the clinical management strategies of >8,000 obstetricians and ~45,000 midwives in the UK (and >1,500,000 practitioners globally).

Public policy

Preterm birth: The specialist clinic model developed at Guys and St Thomas’ NHS Trust was recommended for roll-out in NHS England’s Saving Babies Lives Care Bundle (V2; 2019) [A.1], now rapidly being adopted (currently 50 UK clinics and expanding). The clinic provided the basis of the UK PTB Clinical Network and Research database [A.2] (> 29 UK and international contributing clinics), a forum for clinicians, scientists, and researchers committed to improving the care of women and babies at risk of preterm birth. The UK PTB Network and King’s research influenced guidance for UK commissioners [A.3], led to a Department of Health report recommending a reduction preterm birth from 8% to 6% by 2025, and was instrumental in creating and writing guidance for NHS England [A.4]. The prediction tests and intervention strategies we developed and validated have all been incorporated into National guidance [A.5-7]. Additionally, we contributed to the WHO guideline group on PTB [A.8]. The Tommy’s National Centre for Maternity Improvement is integrating the QUIPP App into a new digital tool for rapid implementation in NHS practice [A.9].

Pre-eclampsia: King’s research providing evidence for PlGF testing was incorporated into the 2016 and 2019 NICE guidelines, [B.1-2], and in the 2020 International Society for the Study of Hypertension in Pregnancy (ISSHP) guidelines [B.3]. NHS England supported widespread implementation of the test (2019) through the Accelerated Access Collaborative and Innovation Technology Payment programmes [B.4], the NHS Directory for general public access [B.5] and the NHS England MedTech Funding Mandate policy 2021/22 [B.6]. Following demonstration of PlGF efficacy in Mozambique, the government introduced PlGF screening as a national policy [B.7]. Early aspirin treatment for prevention of pre-eclampsia in high-risk women has been incorporated into International Federation of Gynecology and Obstetrics (FIGO] (2019) and ISSHP 2020 guidelines [C.1-2] and the NHS England Saving Babies lives care bundle V2 [C.3] and NICE guidelines 2019 [C.4]. The Sierra Leone Government has deployed 3,000 CRADLE VSA devices across its health system [D.1-3]; the VSA was awarded the Inaugural Newton Prize for excellence in research and innovation in support of economic development and social welfare in less developed countries (2017) [D.4], and was amongst the top 30 high impact innovations in global health (PATH-led Award 2015) [D.5]. It has also been recommended for roll-out in refugee camps [D.6-7].

Cholestasis: King’s-generated evidence that serum bile acids are implicated in stillbirth is cited in the Society for Maternal and Fetal Medicine (USA) guideline [E.1], the American Association for the Study of the Liver Practice Guideline [E.2] and in the pre-publication draft of the RCOG Obstetric Cholestasis guideline [E.3]. It influenced the newly released American College of Obstetrics and Gynaecology guidance [E.4] and was voted the most impactful paper of 2019 (6) by the North American Society of Obstetric Medicine [E.5]. Based on King’s research a new NHS Genomic Medicine Service was approved (2019) for screening of women with ICP to identify those with mutations in hepatobiliary disease genes, and at risk of cirrhosis, gallstone pancreatitis or biliary malignancy; with relevance to ~750 women/year in the UK and their relatives [E.6].

Health and Wellbeing

Impact on women’s lives: King’s-led biomarker research for high-risk pregnancy (preterm birth, pre-eclampsia and cholestasis) has had a marked influence on women’s lives. The impact is demonstrated through testimonials from patients attending research-led clinics [F.1-5]. An example from feedback for the King’s preterm birth clinic: “We owe so much to Professor Shennan and his team at Tommy’s Preterm Surveillance Clinic. Without their research and their care, my story would be so different”.

Impact through working with charities: King’s research is made available to the public via charities, e.g. Tommy’s charity, Action on Pre-eclampsia (APEC), The Preeclampsia Foundation (North America), ICP Support and the Borne Charity [G.1-5]. King’s researchers also participate in Facebook sessions with patients via Tommy’s; a video arising from a joint session with ICP Support reached 32,125 people within a week, and was viewed 5024 times [G.6-8]. The CEO of Tommy’s charity stated, “We believe the work we have done with KCL researchers through the Tommy’s Research Centre has had a major clinical impact to improve clinical care and education of women based on the research performed at KCL” [G.1].

Impact through training and teaching: Health and wellbeing has been improved via training informed by our research. Following recommendation for national roll-out of the preterm birth clinic model (National Maternity Ambition), we have held regular training sessions. Nicolaides and Williamson deliver webinars every 2-4 weeks (typically 10-12,000 registrants) that include education about King’s research [H.1]. King’s researchers regularly deliver research-based training (examples include H.2-4). For cholestasis, King’s researchers validated the Royal College of Midwives (48,000 members) i-learn package on cholestasis, that used King’s biomarker research to inform the education of midwives across the UK [H.5].

Commercial

Kings biomarker research has benefited from strong and long-term commercial collaborations. We worked with HOLOGIC in development of the fetal fibronectin quantitative test [I.1]; the company have stated, “your research has helped physicians … better manage their patients presenting with symptoms of preterm labour”, and “the test has become the gold-standard across both the UK and Australia…and many other countries including the USA”, and with Mirvie to develop additional biomarkers for preterm birth prediction [I.2]. Research leading to the development of the cradle BSA device was in collaboration with MicroLife, and >35,000 have been made [I.3]. King’s work on PlGF has been carried out over many years with the manufacturer of the test, Quidel (previously known as Alere) who commented: “On behalf of Quidel I would personally like to thank the KCL team for making such an important contribution to pregnancy care” [I.4-5]. King’s cholestasis research influenced a main producer of the clinically-used bile acid assay, Diazyme, to alter their laboratory protocol such that testing should be performed to determine peak (prandial), rather than fasting, serum bile acid levels, a change proposed by affected women based on the research [I.6-7].