Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT

Article history

The research reported in this article was funded by the HTA programme under project number 12/25/03. The contractual start date was in March 2014. The article began editorial review in July 2021 and was accepted for publication in June 2022. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ article and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article.

Copyright statement

Copyright © 2023 Chappell et al. This work was produced by Chappell et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

2023 Chappell et al.

Clinical uncertainty

We presented the clinical uncertainty in a BMJ article,2 highlighting the tension between optimising the maternal condition (typically by prompt planned delivery) and the unclear balance of benefits and risks for the baby. Preterm birth is known to be associated with short- and long-term morbidity, and expectant management may perpetuate growth restriction (with attendant neurodevelopmental impact) and increase the risk of urgent delivery (if the condition of the woman or fetus deteriorates) and stillbirth. Whereas other trials had evaluated a policy of planned delivery in women with a broader spectrum of pregnancy hypertension disorders, we proposed undertaking a trial in women with pre-eclampsia only, in the United Kingdom (UK) health-care setting, with a health economic evaluation.

Protocol

Full details of the proposed study and analysis plan were published as a protocol. 3 It was prespecified that the findings of the main PHOENIX (Pre-eclampsia in HOspital: Early iNductIon or eXpectant management) study would be divided into publication of the short-term results (up to discharge of the woman and baby from hospital) and subsequent publication of the long-term outcomes (assessed at 2 years after birth) of the women and the babies.

Short-term maternal and infant outcomes in the PHOENIX trial

The short-term trial results were published as a fast-track article in The Lancet. 4 In this parallel-group, non-masked, multicentre, randomised controlled trial carried out in 46 maternity units across England and Wales, we compared planned delivery and expectant management (usual care), with individual randomisation, in women with late preterm pre-eclampsia at 34⁺⁰ to 36⁺⁶ weeks’ gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of ≥160 mmHg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN (International Standard Randomised Controlled Trial Number) registry as ISRCTN01879376. Between 29 September 2014 and 10 December 2018, 901 women were recruited; 450 women [448 women (two withdrew consent) and 471 infants] were allocated to planned delivery and 451 women (451 women and 475 infants) were allocated to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group [289 (65%) women] than in the expectant management group [338 (75%) women] [adjusted relative risk 0.86, 95% confidence interval (CI) 0.79 to 0.94; p = 0.0005]. The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group [196 (42%) infants] than in the expectant management group [159 (34%) infants] (adjusted relative risk 1.26, 95% CI 1.08 to 1.47; p = 0.034). The results from the per-protocol analysis were similar. Expectant management prolonged pregnancy by an average of around 5 days (3 days by adjusted analysis), and 54% of women in the expectant management group needed expedited delivery for maternal or fetal indications. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group. We concluded that there is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. We advised that this trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision-making on timing of delivery.

Secondary analysis of short-term PHOENIX outcomes

A secondary analysis of the study was undertaken to present results stratified by gestational age and to evaluate outcomes of induced labour in women with late preterm pre-eclampsia. 5 We demonstrated that in women who started induction of labour, 63% of women delivered vaginally (56% at 34 weeks’ gestation). Compared with expectant management, planned delivery was associated with higher rates of neonatal unit admission for prematurity (but lower proportions of small-for-gestational-age infants); length of neonatal unit stay and neonatal morbidity (including respiratory support) were similar across both trial groups at all gestational windows. Neonatal unit admission was more common among infants delivered at an earlier gestational age, small-for-gestational age infants and infants of women who developed severe pre-eclampsia. Documented neonatal morbidity at discharge and lengths of stay were similar between the trial groups at each gestational age (weeks), suggesting that these admissions may reflect clinicians’ behaviour.

Linked prognostic cohort study: the PEACOCK study

Two linked studies were undertaken, both addressing additional uncertainties around the main research question. In the first of these linked studies, funded by the NIHR HTA programme (15/59/06), we sought to establish a prognostic model to inform optimal timing of delivery in women with late preterm pre-eclampsia, comparing concentrations of placental growth factor (PlGF) with clinical and routinely collected blood and urinary parameters to determine clinically indicated need for delivery for pre-eclampsia (or related complications) within 7 days of assessment. The findings were published in a journal article6 and in the NIHR Journals Library. 7 The PEACOCK (Prognostic indicators of severe disEAse in women with late preterm pre-eClampsia tO guide decision-making on timing of delivery) study was a prospective cohort study nested within the PHOENIX trial. We undertook prospective recruitment of women in 36 maternity units across England and Wales between 34⁺⁰ and 36⁺⁶ weeks’ gestation with a diagnosis of pre-eclampsia and in whom blood samples for PlGF testing were obtained, alongside clinical data, for use in the PREP-S (Prediction models for Risk of Early-onset Pre-eclampsia – Survival) model. The main outcome measure was clinically indicated need for delivery for pre-eclampsia within 7 days of assessment. For statistical analysis, both PREP-S score and PlGF concentration were assessed and compared using standard methods (sensitivity and specificity for PlGF thresholds of 100 pg/ml and <12 pg/ml; receiver operating characteristic areas for continuous measurements). The estimated probability of early delivery from PREP-S was compared with actual event rates among women with similar probabilities by calibration. Calibration using logistic regression was also used. Between 27 April 2016 and 24 December 2018, 501 women were recruited to the study. Although PlGF testing had high sensitivity (97.9%) for delivery within 7 days, the negative predictive value was only 71.4%, and the specificity was low (8.4%). The area under the curve for the clinical prediction model (PREP-S) and PlGF in this cohort in determining need for delivery within 7 days was 0.64 (standard error 0.03) and 0.60 (standard error 0.03), respectively, and 0.65 (standard error 0.03) in combination. We noted that a high proportion of women in this cohort already had low PlGF concentrations at the time of confirmed diagnosis, which reduced the ability of the biomarker to further predict adverse outcomes. We concluded that, in this group of women with late preterm pre-eclampsia, PlGF measurement is not likely to add to the current clinical assessment to help plan care for late preterm pre-eclampsia regarding timing of delivery. Existing models developed in women with early-onset pre-eclampsia to predict complications cannot be used to predict clinically indicated need for delivery in women with late preterm pre-eclampsia.

Linked mechanism of action study: the PHOEBE study

In the second of these linked studies, funded by the NIHR Efficacy and Mechanism Evaluation (EME) programme (15/23/02), we evaluated the mechanism of action underlying the known association between pre-eclampsia and the development of cardiovascular disease, assessing whether or not planned delivery affected maternal echocardiographic measures of cardiac dysfunction and blood pressure 6 months after birth (the PHOEBE study). We published the findings in a journal article8 and in the NIHR Journals Library. 9 In 28 maternity hospitals in England and Wales, we approached women who were eligible for the PHOENIX study and offered participation in the PHOEBE study. Additional post-partum follow-up included medical history, blood pressure assessment and echocardiography (at 6 months). All women had blood sampling performed at at least two time points from recruitment to 6-month follow-up for assessment of cardiac necrosis markers. The primary outcome was a composite of systolic and/or diastolic dysfunction (originally by 2009 guidelines,10 updated by 2016 guidelines,11 with an amended definition of diastolic dysfunction). Analyses were by intention to treat together with a per-protocol analysis for the primary and secondary outcomes. Between 27 April 2016 and 30 November 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited. A total of 133 women were allocated to planned delivery, 137 women were allocated to expectant management and a further 150 received non-randomised expectant management as part of usual care. The mean time from enrolment to delivery was 2.5 days [standard deviation (SD) 1.9 days] in the planned delivery group and 6.8 days (SD 5.3 days) in the expectant management group. There were no differences in the primary outcome between women in the planned delivery group and women in the expectant management group using either the 2009 definition (risk ratio 1.06, 95% CI 0.80 to 1.40) or the 2016 definition (risk ratio 0.78, 95% CI 0.33 to 1.86). Overall, 10% (31/321) of women had a left ventricular ejection fraction <55%, and 71% of the cohort remained hypertensive at 6 months post partum. No differences were observed between the two groups in cardiorespiratory outcomes prior to discharge from hospital or in systolic or diastolic blood pressure. Variables associated with the primary outcome (2009 definition) at 6 months post partum were maternal body mass index (adjusted odds ratio 1.33 per 5 kg/m², 95% CI 1.12 to 1.59 per 5 kg/m²) and maternal age (adjusted odds ratio 2.16 years, 95% CI 1.44 to 3.22 per 10 years). Limitations include changing definitions regarding systolic and/or diastolic dysfunction. We concluded that preterm pre-eclampsia results in persistence of hypertension in the majority of women with late preterm pre-eclampsia at 6 months post partum, and systolic dysfunction in 10%, and that pre-eclampsia should not be considered a self-limiting disease of pregnancy alone. This study underlined the importance of conceptualising pre-eclampsia as a disease with life-long cardiovascular implications.

Two-year infant and maternal outcomes in the PHOENIX trial

We continued follow-up to 2 years post birth to evaluate the best time to initiate delivery in late preterm pre-eclampsia to optimise infant and maternal outcomes. 12 For this part of the trial, the primary long-term outcome was infant neurodevelopmental outcome at 2 years of age, using the Parent Report of Children’s Abilities-Revised (PARCA-R) composite score. At the 2-year follow-up, the intention-to-treat analysis population included 276 women (290 infants) allocated to planned delivery and 251 women (256 infants) to expectant management. The mean composite standardised PARCA-R scores were 89.5 points (SD 18.2 points) in the planned delivery group and 91.9 points (SD 18.4 points) in the expectant management group, with an adjusted mean difference of –2.4 points (95% CI –5.4 to 0.5 points; non-inferiority p = 0.147). We concluded that, in infants of women with late preterm pre-eclampsia, average neurodevelopmental assessment at 2 years was within the normal range, regardless of whether planned delivery or expectant management was pursued. Because of lower than anticipated levels of follow-up, there was limited power to demonstrate that these scores were not different, but the small between-group difference in PARCA-R scores was unlikely to be clinically important. 12

Health economic evaluation

The objective of the health economic evaluation was to evaluate the 2-year cost–utility of planned delivery for women with late preterm pre-eclampsia at 34⁺⁰ to 36⁺⁶ weeks’ gestation compared with expectant management from an NHS perspective. 13 We undertook an economic evaluation alongside the multicentre randomised controlled trial (PHOENIX), using participant-level data. Women were individually randomised to planned delivery or expectant management. Resource use was collected from hospital records between randomisation and primary hospital discharge following birth. Women were followed up at 6 months and 2 years following birth, and we collected self-reported resource use for them and their infant(s) covering the previous 6 months. Women completed the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at randomisation and follow-up. The main outcome measure was incremental cost per quality-adjusted life-year (QALY) gained. A total of 450 women were randomised to planned delivery and 451 to expectant management; 187 and 170 women, respectively, had complete data at 24 months. Planned delivery resulted in a significantly lower mean cost per woman and infant(s) over 2 years (–£2711, 95% CI –£4840 to –£637), with a mean incremental difference of 0.019 QALYs (95% CI –0.039 to 0.063 QALYs). Short- and long-term infant costs were not significantly different between the trial arms. We concluded that there is a high probability that planned delivery is cost-effective compared with expectant management. These results13 need to be considered alongside clinical outcomes and in the wider context of maternity care.

Patient and public involvement

Equality, diversity and inclusion

The study enrolled 901 pregnant women in the main PHOENIX trial from 46 maternity units in England and Wales. A total of 30% of women were from non-White ethnic minority groups and 70% of women were from White ethnic groups [following Office for National Statistics (ONS) ethnic group descriptors]. In ONS data on live births in 201814 (the most recent year of recruitment into the PHOENIX trial), 72% of women were from a White ethnic group, suggesting that the women recruited were broadly representative of the wider pregnancy population. The mean age of pregnant women in the PHOENIX trial was within the most common age category reported by the ONS in 2018. 15

We are not aware of any published data on ethnicity groupings specifically for women with late preterm pre-eclampsia (between 34⁺⁰ and 36⁺⁶ weeks’ gestation) in the UK between 2014 and 2018 to ascertain whether or not our participants were representative of the wider population. However, our wide geographical diversity of maternity units, inclusive approach to recruitment and enrolment of a similar proportion of women from non-White ethnic minority groups is in keeping with the wider pregnancy population characteristics and suggests that our research teams enabled participation by a diverse group of women and that our findings are generalisable.

Implication for practice/decision-makers

This study adds considerably to the body of literature on planned delivery in late preterm pre-eclampsia, more than doubling the number of women enrolled in similar studies to date. The results show that women with late preterm pre-eclampsia should be informed of the benefits and risks of planned delivery compared with expectant management, specifically including the following:

• Expectant management will prolong pregnancy by an average of 3–5 days.

• Around 54% of women managed expectantly will need expedited delivery for maternal or fetal indications, with a 74% chance of progressing to severe pre-eclampsia (compared with 64% of women progressing to severe pre-eclampsia with planned delivery).

• Planned delivery significantly reduces maternal complications, including severe high blood pressure.

• Planned delivery is associated with more babies being admitted to the neonatal unit because of prematurity, but with no clinically relevant differences in neonatal morbidity, suggesting that this may be a precautionary measure.

• At 2 years after birth, infants in both groups have development scores in the normal range.

• Planned delivery is around £2700 cheaper for the health service, mainly because of shorter stays in the neonatal unit and fewer complications for the women, with no overall difference in neonatal unit admission costs between the groups.

Since publication of the trial, an individual patient data meta-analysis has been undertaken to compare planned delivery with expectant management, focusing specifically on women with pre-eclampsia after 34 weeks’ gestation. This concluded that planned early delivery provides clear maternal benefits and may reduce the risk of the infant being born small for gestational age, with a possible increase in short-term neonatal respiratory morbidity. The article reiterated that potential benefits and risks of prolonging a pregnancy complicated by pre-eclampsia should be discussed with women as part of a shared decision-making process. 16

Research recommendations

We identified the following questions for future research, and have indicated the area of research to which they relate. We suggest that a more formal process of scoping and prioritisation is undertaken to determine how these are best taken forward in the wider context of pregnancy research and ongoing work in this area.

Conclusion

In women with late preterm pre-eclampsia, planned delivery reduces short-term maternal morbidity (including severe hypertension) compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater short-term neonatal morbidity. At 2-year follow-up, average infant development was within the normal range for both groups; the small between-group mean difference in PARCA-R scores is unlikely to be clinically important. Planned delivery was significantly cost-saving to the health service. These findings should be discussed with women with late preterm pre-eclampsia to allow shared decision-making on timing of delivery.

Contributions of authors

Lucy C Chappell (https://orcid.org/0000-0001-6219-3379) was co-chief investigator, contributed to study design, delivery, analysis and interpretation and wrote the first draft of the report.

Peter Brocklehurst (https://orcid.org/0000-0002-9950-6751) was a member of the co-investigator group.

Marcus Green (https://orcid.org/0000-0002-4561-8256) contributed in a PPI capacity throughout the study.

Pollyanna Hardy (https://orcid.org/0000-0003-2937-8368) was a member of the co-investigator group.

Rachael Hunter (https://orcid.org/0000-0002-7447-8934) was a member of the co-investigator group and undertook the health economic analyses.

Alice Beardmore-Gray (https://orcid.org/0000-0001-9923-4912) contributed to the analysis and writing of the PHOENIX 2-year outcomes paper.

Ursula Bowler (https://orcid.org/0000-0002-0100-0155) contributed to study management.

Anna Brockbank (https://orcid.org/0000-0002-2764-0556) contributed to sample management and aspects of laboratory analysis for the PHOEBE and PEACOCK studies nested within the PHOENIX RCT.

Virginia Chiocchia (https://orcid.org/0000-0002-6196-3308) undertook statistical analyses.

Alice Cox (https://orcid.org/0000-0001-5961-4793) contributed to study management.

Kate Duhig (https://orcid.org/0000-0001-9176-5671) contributed to the analysis and writing of the PEACOCK prospective cohort study nested within the PHOENIX RCT.

Jessica Fleminger (https://orcid.org/0000-0002-5744-5137) contributed to study management.

Carolyn Gill (https://orcid.org/0000-0003-0012-5105) contributed to sample management and aspects of laboratory analysis for the PHOEBE and PEACOCK studies nested within the PHOENIX RCT.

Melanie Greenland (https://orcid.org/0000-0001-9363-8844) undertook statistical analyses.

Eleanor Hendy (https://orcid.org/0000-0002-8168-0735) contributed to study management.

Ann Kennedy (https://orcid.org/0000-0003-0290-396X) contributed to study management.

Paul Leeson (https://orcid.org/0000-0001-9181-9297) was a member of the co-investigator group for the PHOEBE study.

Louise Linsell (https://orcid.org/0000-0003-3205-6511) undertook statistical analyses.

Fergus P McCarthy (https://orcid.org/0000-0001-5062-6851) was co-chief investigator for the PHOEBE study.

Jamie O’Driscoll (https://orcid.org/0000-0002-5923-4798) undertook and analysed all echocardiography assessments for the PHOEBE mechanisms of action study nested within the PHOENIX RCT.

Anna Placzek (https://orcid.org/0000-0002-6745-5996) contributed to study management.

Lucilla Poston (https://orcid.org/0000-0003-1100-2821) was involved in the study conception and in securing funding for the PHOEBE mechanisms of action study nested within the PHOENIX RCT.

Stephen Robson (https://orcid.org/0000-0001-7897-7987) was a member of the co-investigator group.

Pauline Rushby (https://orcid.org/0000-0003-2176-6593) contributed to study management.

Jane Sandall (https://orcid.org/0000-0003-2000-743X) was a member of the co-investigator group.

Laura Scholtz (https://orcid.org/0000-0002-4377-4669) contributed to study management.

Paul T Seed (https://orcid.org/0000-0001-7904-7933) undertook statistical analyses for the PHOEBE and PEACOCK studies nested within the PHOENIX RCT.

Jenie Sparkes (https://orcid.org/0000-0002-9973-544X) contributed to study management.

Kayleigh Stanbury (https://orcid.org/0000-0002-8726-2411) contributed to study management.

Sue Tohill (https://orcid.org/0000-0002-2344-4347) contributed to study management.

Basky Thilaganathan (https://orcid.org/0000-0002-5531-4301) was a member of the co-investigator group for the PHOEBE study.

John Townend (https://orcid.org/0000-0001-5455-2562) undertook statistical analyses.

Edmund Juszczak (https://orcid.org/0000-0001-5500-2247) was a member of the co-investigator group.

Neil Marlow (https://orcid.org/0000-0001-5890-2953) was a member of the co-investigator group.

Andrew Shennan (https://orcid.org/0000-0001-5273-3132) was co-chief investigator.

Publications

Chappell LC, Milne F, Shennan A. Is early induction or expectant management more beneficial in women with late preterm pre-eclampsia? BMJ 2015;350:h191.

Chappell LC, Green M, Marlow N, Sandall J, Hunter R, Robson S, et al. Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial). Trials 2019;20:85.

Chappell LC, Brocklehurst P, Green ME, Hunter R, Hardy P, Juszczak E, et al. Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. Lancet 2019;394:1181–90.

Duhig K, Seed PT, Placzek A, Sparkes J, Gill C, Brockbank A, et al. A prognostic model to guide decision-making on timing of delivery in late preterm pre-eclampsia: the PEACOCK prospective cohort study. Health Technol Assess 2021;25(30).

Fleminger J, Duhig K, Seed PT, Brocklehurst P, Green M, Juszczak E, et al. Factors influencing perinatal outcomes in women with preterm preeclampsia: a secondary analysis of the PHOENIX trial. Pregnancy Hypertens 2021;26:91–3.

Duhig KE, Seed PT, Placzek A, Sparkes J, Hendy E, Gill C, et al. Prognostic indicators of severe disease in late preterm pre-eclampsia to guide decision making on timing of delivery: the PEACOCK study. Pregnancy Hypertens 2021;24:90–5.

McCarthy FP, O’Driscoll J, Seed P, Brockbank A, Cox A, Gill C, et al. Planned delivery to improve postpartum cardiac function in women with preterm pre-eclampsia: the PHOEBE mechanisms of action study within the PHOENIX RCT. Efficacy Mech Eval 2021;8(12).

McCarthy FP, O’Driscoll JM, Seed PT, Placzek A, Gill C, Sparkes J, et al. Multicenter cohort study, with a nested randomized comparison, to examine the cardiovascular impact of preterm preeclampsia. Hypertension 2021;78:1382–94.

Beardmore-Grey A, Greenland M, Linsell L, Juszczak E, Hardy P, Placzek A, et al. Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. BJOG 2022;129:1654–63.

Beardmore-Gray A, Seed PT, Fleminger J, Zwertbtoek E, Bernardes T, Mol BW, et al. Planned delivery or expectant management in preeclampsia: an individual participant data meta-analysis. Am J Obstet Gynecol 2022;227:218–30.

Hunter R, Beardmore-Gray A, Greenland M, Linsell L, Juszczak E, Hardy P, et al. Cost-utility analysis of planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX). PharmacoEcon Open 2022;6:723–33.

Ethics statement

The trial was approved by the South Central – Hampshire B Research Ethics Committee (13/SC/0645) on 19 December 2013.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Funding

This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in Health Technology Assessment; Vol. 27, No. 28. See the NIHR Journals Library website for further project information.

Article history

The research reported in this article was funded by the HTA programme under project number 12/25/03. The contractual start date was in March 2014. The article began editorial review in July 2021 and was accepted for publication in June 2022. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ article and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article.

Disclaimers

This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.