Stakeholder engagement

Introduction

In this workstream, we describe OPTI-PREM engagement with relevant stakeholders throughout the project. This was to reassure LNU and NICU teams regarding the intent of the project, and to ensure that the questions, ideas and concerns by stakeholders (clinicians, decision-makers, managers, researchers, parents, members of the public) could be utilised to enhance the analysis and interpretation of the data. The potential implications of our findings are discussed. Dissemination of information around the findings of OPTI-PREM is in progress.

Aim

To engage with stakeholders regarding OPTI-PREM.

Objectives

Collaboration with stakeholders to

1. review with neonatal teams the study design and plan
2. share preliminary results for face validity
3. incorporate stakeholder comments into study analysis and interpretation of findings
4. identify potential implications of the study findings, and future work needed to fine-tune this
5. promote dissemination of study results.

Methods

We held multiple discussions and workshops with key stakeholders.

1. Early engagement with a national LNU working group: this included BLISS Parent Advisory Panel participation.

Rationale: The study team was careful to include representatives from the national organisation supporting perinatal medical and nursing care in England, the BAPM. This was to allay anxieties that the work could be targeted towards a NICU outcome, based on the predominant NICU representation of clinicians who were driving the project. As a result, a call-out was made to BAPM for a LNU working group to review the project design and advise of any shortcomings that could disadvantage LNU in the analyses.

1. Review of results stage: we engaged with stakeholders involved in neonatal service decision-making from LNU and NICU units, operational delivery networks and national government bodies involved in neonatal and maternity health care, together with parent panel and BLISS support at two time points:
   1. when the first results were available, and
   2. after near completion of all workstream results.

Transcripts from the stakeholder meetings were analysed and themes manually extracted. These were either included in the analysis and reporting of the study or justified, if the study team perspectives were different, in the discussion in this NIHR report.

1. Presentation of project and findings at national, international and regional forums and submission of main findings to high-impact peer-reviewed medical journals.

Results

National stakeholder engagement with OPTI-PREM

Early engagement with British Association of Perinatal Medicine local neonatal unit working group

A 1-day meeting was as a round-table workshop on 4 October 2019. There was representation from four different LNU from the East Midlands Operational Delivery Network (ODN), South West Neonatal ODN (two representatives, from different LNU) and West Midlands ODN. All LNU consultants attending were BAPM members. Each workstream lead presented their plans, with preliminary data where available.

The outcome from the meeting was positive, and the LNU members attending supportive of the work, its design and intent. There were no concerns regarding the project direction. Ideas regarding dealing with confounding factors such as congenital anomalies, multiple pregnancies, maternal illness, analysis, and interpretation of preliminary data were discussed. These have been assimilated into the project report where appropriate.

National stakeholder engagement with preliminary results

Two meetings were held in April 2022: a national parent stakeholder meeting on 11 April 2022, followed by combined (parent and professional) national stakeholder meeting on 25 April 2022. The national stakeholder meetings were virtual, using an MS Teams^® (Microsoft Corporation, Redmond, WA, USA) platform. Both meetings were chaired by the chairman of OPTI-PREM study steering committee.

11 April 2022: Four parents responded to a BLISS advert for the meeting, and participated in discussions around the preliminary findings, together with the parent panel lead, a BLISS representative. The perspectives of parents and members of the public were collated and represented at the meeting on 25 April 2022, by the parent panel lead.

25 April 2022: A further 76 individuals across England, Northern Ireland, Scotland and Wales participated in the national stakeholder meeting on this day. These included:

1. Maternity ODN: managers, clinical leads, their representatives and interested clinicians and midwives
2. Neonatal ODN: managers, clinical leads, their representatives and interested clinicians
3. Royal College of Paediatrics and Child Health National Neonatal Audit Programme Lead
4. Representation from NHS England, Public Health Scotland, Northern Ireland and Wales
5. Parents and members of the public (n = 7, responding to a second national call-out through BLISS)
6. the senior engagement officer at BLISS.

We elected first to engage with colleagues and managers, clinicians and researchers in neonatal and maternity care and members of the public. We anticipated that detailed discussions with the Royal College of Midwifery, Neonatal Nursing Association and the Royal College of Obstetrics and Gynaecology would begin after submission of the NIHR project report and peer review of this work. Ideas shared, expressed and explained were assimilated and are included in this NIHR report (see Report Supplementary Material 10).

Presentation at conferences and regional meetings

1. NNAP-NDAU National Collaborators meeting, Leeds, 18 March 2019: oral presentation to parents, multidisciplinary neonatal unit staff members and neonatal network representatives.
2. Health Systems Research UK Conference, Manchester, 2–3 June 2019: oral presentation to NHS research audience.
3. 5th Annual Preterm Births Conference, Birmingham UK, 30 September 2019: oral presentation to obstetricians (UK and internationally), with an interest in reducing preterm births. Further regional presentations to ODNs that requested further information were conducted.
4. Evidence and Excellence joint BAPM EBNeo conference, Newcastle, UK, 11–13 September 2019: our systematic checks in data and the lessons learnt from using large-scale routinely collected national data were presented as a poster titled ‘Using routinely recorded operational clinical data from electronic patient records for clinical research: The challenges and messages from OPTI-PREM, a national study evaluating best place of care for babies born at 27–31 weeks gestation’, Yang M, et al.
5. BAPM Annual Conference ‘Addressing Inequalities in Perinatal Care’, Sheffield, UK on 5 October 2021: oral presentation to a national audience. The stakeholders were neonatal consultants, neonatal nurses, and those interested in perinatal care, decision-makers at neonatal unit and regional level.
6. UK Neonatal Society Meeting on 10 March 2023, London, UK: oral presentation of morbidity outcomes data, to an international audience, with interest in neonatal research. The audience included neonatal consultants and researchers involved in neonatal basic science and clinical research, and clinicians who had decision-making responsibility for their units and regions.
7. UK Neonatal Society Meeting on 4 March 2021 and Perinatal Conference UK 2020, London, UK . There was a general acceptance of the findings, and questions were similar to those described in Report Supplementary Material 10.
8. HSR UK conference on 5–7 July 2022 in Sheffield, UK: the overall OPTI-PREM project was presented (short oral) as ‘Place of care for babies born at 27–31 weeks in England: a qualitative study of staff decision-making perspectives and practices’. There were no concerns raised and there wasgeneral acceptance of the methodologies utilised. Workstream 4 was also presented at the conference.
9. British Sociological Association Medical Sociology Conference 11–13 September 2019, York, UK: workstream 4 results were presented at this meeting.
10. Royal College of Obstetrics and Gynaecology World Congress, London 12–14 June 2023: workstream 1 findings were presented orally at this international congress.
11. BAPM autumn meeting September 11–12, 2023, Sheffield, UK: workstream 1 findings were presented orally at this national congress for neonatologists and perinatal teams.

List of published papers from OPTI-PREM

1. Pillay T, Modi N, Rivero-Arias O, Manktelow B, Seaton SE, Armstrong N, et al. Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol. BMJ Open 2019;9:e029421. https://doi.org/10.1136/bmjopen-2019-029421
2. Ismail AQT, Boyle EM, Pillay T, Boyle EM, Modi N, Rivero-Arias O, et al. Clinical outcomes for babies born between 27–31 weeks of gestation: should they be regarded as a single cohort? J Neonatal Nurs 2022;29:27–32. https://doi.org/10.1016/j.jnn.2022.04.003
3. Ismail AQT, Boyle EM, Pillay T; OPTI-PREM Study Group. The impact of level of neonatal care provision on outcomes for preterm babies born between 27 and 31 weeks of gestation, or with a birth weight between 1000 and 1500 g: a review of the literature. BMJ Paediatr Open 2020;4:e000583. https://doi.org/10.1136/bmjpo-2019-000583. eCollection 2020
4. Ismail AT, Boyle EM, Oddie S, Pillay T. Exploring variation in quality of care and clinical outcomes between neonatal units: a novel use for the UK National Neonatal Audit Programme (NNAP). BMJ Open Qual 2022;11:e002017. https://doi.org/10.1136/bmjoq-2022-002017
5. Yang M, Campbell H, Pillay T, Boyle EM, Modi N, Rivero-Arias O. Neonatal health care costs of very preterm babies in England: a retrospective analysis of a national birth cohort. BMJ Paediatr Open 2023;7. https://doi.org/10.1136/bmjpo-2022-001818
6. Cupit C, Paton A, Boyle E, Pillay T, Armstrong N; OPTI-PREM Study Group. Managerial thinking in neonatal care: a qualitative study of place of care decision-making for preterm babies born at 27–31 weeks gestation in England. BMJ Open 2022;12:e059428. https://doi.org/10.1136/bmjopen-2021-059428
7. Paton A, Cupit C, Armstrong N. Organising work in neonatal transfer: Optimising place of care for babies born moderately preterm. Sociol Health Illn 2023;45:1634–51. https://doi.org/10.1111/1467-9566.13656
8. Cupit C, Paton A, Boyle E, Pillay T, Anderson J, Armstrong N. Parenting through place‐of‐care disruptions: a qualitative study of parents’ experiences of neonatal care. Health Expectations. 2023;1. https://doi.org/10.1111/hex.13933

Doctor of Philosophy

Ismail AQT. Exploring the relationship between care provided and outcomes for preterm babies born between 27 and 31 weeks gestation in England. PhD successfully defended July 2023, University of Leicester

Presentation of near-final results to key stakeholders

A presentation of OPTI-PREM findings was held on 23 March 2023. Participants were the leads for

• the Neonatal Clinical Reference Group
• the National Neonatal Critical Care Transformation Programme
• BAPM
• GIRFT Neonatology
• National Clinical Director for Maternity Review and Women’s Health
• National Programme of Care Manager for Women and Children NHS England
• RCPCH NNAP
• research engagement in BLISS, the national charity for parents of babies born premature or sick.

The purpose of the meeting was to briefly share the findings from OPTI-PREM and to get a steer on the implications of our observations.

Points of discussion in stakeholder meeting

Our scientific observations are that for England, based on current practice:

1. The clinically safe threshold for care for babies born at 27–31 weeks gestation in either NICU or LNU is 28 weeks. For babies born at 27 weeks gestation, care in LNU is associated with a higher rate of SBI. This appears to also be related to postnatal transfers.

This suggests that antenatal triage to maternity services colocated with NICU is advantageous for expectant preterm births at 27 weeks gestation.

This finding was accepted, and the strength of significance at 99% CI was acknowledged. However, it was noted that capacity in NICU was the determining factor. A discussion on high-volume and low-volume LNU was raised at the meeting, as, if high-volume LNU were functioning as effectively as NICU in relation to SBIs then, recommending only low-volume LNU plans for in utero transfers would limit the capacity burden currently facing NICU. On further analysis our work supports that the benefits of reduced SBI apply for NICU over all LNU. The justification for this is as follows:

Justification: the definition of high-volume and low-volume used in the OPTI-PREM project was based on previous scientific study,11 and the experience of teams looking after babies born at < 32 weeks gestation.

We analysed this (using the IV approach and adjusting for confounders) for high versus low volume using two definitions of high versus low volume:

1. the single uppermost quartile (high volume) versus the lower three quartiles (low volume) on the number of IC days provided to babies born at < 32 weeks gestation in the unit; or
2. the upper three quartiles (high volume) versus the single lowermost quartile (low volume) on the number of IC days provided to babies born at < 32 weeks gestation in the unit.

We observed that the difference in SBI was significant for high-volume versus low-volume units when the single uppermost quartile was used to define high/low volume (threshold 1614 days/year of providing IC to babies born at < 32 weeks gestation), but not when the single lowermost quartile was used to define high/low volume (threshold 440 days/year of providing IC to babies born at < 32 weeks gestation).

Current service specification low-volume units are defined as those providing < 1000 IC and HD days for all babies in the neonatal unit, and there are 26 of these identified in the UK. We were unable to run our analysis comparing these 26 units against the rest, as the data for OPTI-PREM were pseudonymised, and we did not have unit permissions to explore this. All low-volume neonatal units provided between < 268 IC days per year overall in 2019 [GIRFT data, with permission, E Adams (Getting It Right First Time; NHS England)].15

Loss of significant differences in SBI using the OPTI-PREM definitions at a low-volume threshold of 440 days IC days (for babies born at < 32 weeks gestation) while noting differences at a threshold of 1614 IC days (for babies born at < 32 weeks gestation) suggests that further subdivision to service specification thresholds for low-volume (< 268 IC days for all babies) are unlikely to yield significant differences for SBI. Our initial scientific observation that expectant births at 27 weeks gestation in maternity services colocated with NICU versus LNU therefore remains.

There may be future work required to refine NICU care, as high-volume units using the upper quartile for IC days incorporated NICU only, and here we found statistically significant differences for SBI.

1. Our data suggest that capacity transfers at 27 weeks gestation offer no advantage for SBI and should cease; there were no objections to this.
2. A discussion on the difficulties of distinguishing between uplifts for clinical care compared with uplifts for protocol-driven reasons was noted. The suggestion that clinical teams risk-assess the need for clinical transfer at 27 weeks gestation is dependent on clinical team capabilities, and an assessment of the degree of illness in the baby. We do not wish to make any recommendation that could worsen outcomes for babies born at 27 weeks gestation who are retained at LNU.
3. It was noted that outcomes were no different between NICU and LNU for babies born at 28–31 weeks gestation. Here again, stakeholders were cautious of recommending transfers to make capacity, as this would take families further away from home. The issue of redirecting the burden of SBI to babies of higher gestational age was noted as a theoretical possibility, as transfers in this age group could potentially increase, to make capacity for those at 27 weeks gestation in NICU.

The remaining points were noted and accepted:

1. High-quality care, measured by the culture of units in adhering to evidence-based or consensus-based early preterm care, is associated with a shortened length of neonatal stay.
2. The costs of care in LNU and NICU amount to ~0.26 billion pounds a year and are driven by daily care costs, not by specialised medications costed separately.
3. Cost-effectiveness of care: data on this was not presented at this meeting, and will be presented, in the dissemination phase of this work. (For the purposes of this report, there was no difference in cost of care between NICU and LNU for births between 27 and 29 weeks gestation. This suggests that the recommendation of antenatal transfer to maternity services colocated with a NICU will be cost neutral per baby. The cost savings to the NHS of preventing SBI has not been calculated in this project. However, it can be assumed that this will represent a cost saving to the NHS and to society.)
4. Parents value optimising their baby’s development and getting baby home. They place emphasis on continuity of care, integration of families in care of their baby, and support for their physical and mental well-being.

Discussion

In all the stakeholder meetings, the OPTI-PREM project protocol was accepted, participants understood the nature of the project and there were no areas of dissent. At the obstetrics preterm birth meeting, it was noted that care needed to be taken to ensure that unmeasured confounders due to degree of maternal illness were adequately addressed. The aspects discussed in Report Supplementary Material 10 with national stakeholders overlapped with ideas expressed at these meetings and so are not repeated. When presented to our stakeholder discussion on 23 March 2023, multiple points were reviewed regarding the implication of OPTI-PREM findings. These, together with OPTI-PREM study team review, are discussed in the next section. They provide context to potential considerations for policy-making in neonatal service delivery once the scientific findings from OPTI-PREM are published.