OPTI-Prem

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The Royal Wolverhampton NHS Trust (RWT) requires access to NHS England Data for the purpose of the following research project: OPTI-PREM: Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation using national data, qualitative research and economic analysis. [1 paragraph unchanged] The Neonatal Data Analysis Unit (NDAU) is a section within Imperial College's Chelsea and Westminster hospital Hospital campus. The NDAU receives pseudonymised neonatal data for the whole of England [33 words unchanged] data for new-born babies in the UK. All employees at NDAU are substantiate substantive Imperial College staff. More details about NDAU and NNRD at https://www.imperial.ac.uk/neonatal-data-analysis-unit. The Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation in England, using national data, qualitative research and economic analysis (OptiPREM) study, is one that seeks to establish best place of care for babies born between 27-31 [22 words unchanged] England. As part of the work for the OptiPREM study, additional data is was required on babies born between 27 – 31 weeks in England, beyond [8 words unchanged] captures information on babies while they are admitted in the neonatal unit). The cohort is all babies born with a gestational age between 27+0 weeks and 31+6 weeks at birth, and discharged between the time periods 01 January 2014 to 31 December 2018 in England. This extra information required for the project involved an assessment of hospital care, for up to two years of age. This includes hospital care after the baby has been discharged from neonatal care i.e. readmitted or reviewed in a hospital setting after being discharged from the neonatal unit. This hospital care for babies after discharge from neonatal care is captured in NHS England HES & Mortality Data, and is the reason for this NHS England application The project aims to improve health outcomes overall – the likely full impact of this project can be seen in the Expected Benefits section of this Agreement. These include impact on babies, mothers, families, clinical teams, health care providers service provision and commissioning. NHS England Data is used in a part of the OptiPrem project (Workstream 3). This workstream evaluates the cost of care for all preterm babies born between 27-31 weeks in England, up to the time they reach two years of age. It seeks to discover whether it is cost effective to be born and looked after in one of two types of neonatal units: a neonatal intensive care unit (NICU) or a local neonatal unit (LNU). The study assess whether this influences the longer-term cost of medical care up to two years of age). The dataset for this project is called The OptiPrem dataset and comes from the NNRD. It is important to note that the economic cost of care forms just one stream of the entire project. The project evaluates best place of care based on key clinical outcomes i.e mortality and major morbidity. These are undertaken in different workstreams that do not require NHS England linkage and are not part of this application. In the event that there is no difference in place of care, based on the key clinical outcomes, then the economic cost of care will be used to define recommendations nationally, together with parent staff perceptions (separate workstream). The NNRD only captures neonatal admission data (this usually lasts a few weeks for babies born in this age group 27-31 weeks). This project looks at outcomes (hospital admissions, critical care, out-patient visits, and deaths up to two years of age) and works out the costs associated with this care. The OptiPREM study team at University of Oxford used NHS England Data to cover the two-year time point that is needed; this is not available via the NNRD. The OptiPREM study team at University of Oxford used the NNRD data to calculate costs of care while the baby is an inpatient on the neonatal unit (captured on NNRD and not on NHS England), and the NHS England HES and mortality Data is used to calculate the cost of care after the baby is discharged from the neonatal unit up to time of death or two years of age (this is captured on NHS England HES/Mortality). The OptiPREM team utilised the Data from NHS England (HES and mortality), linked to the OptiPrem cohort babies (27-31 weeks gestation) in the OptiPrem dataset. [1 paragraph unchanged] This extra information required for the project involves an assessment of hospital care, for up to two years of age. This includes hospital care after the baby has been discharged from neonatal care i.e. readmitted or reviewed in a hospital setting after being discharged from the neonatal unit. The OptiPREM team based at University of Oxford calculate the cost of care for babies born at each gestational age (i.e. 27, 28, 29, 30, 31 weeks) and for each type of unit (i.e. Local Neonatal Unit vs Neonatal Intensive Care Unit) while they are in hospital in a neonatal unit (i.e. the first few weeks of life), using NNRD data, and then after they are discharged from the neonatal unit, and are seen at hospital/outpatient clinic/critical care/ etc up to time of death or two years of age, whichever comes first. For the latter Data from NHS England is used. This hospital care for babies after discharge from neonatal care is captured by NHS Digital HES/Mortality, and is the reason for this NHS Digital application To calculate the cost of this care after discharge from the neonatal unit, the OptiPREM team required a link between each baby born in this gestational age group, and their HES and Mortality record, held at NHS England. This information is linked using their identifiers such as NHS number. The project aims to improve health outcomes overall – the likely full impact of this project can be seen in section 5d below. These include impact on babies, mothers, families, clinical teams, health care providers service provision and commissioning. NHS Digital data will be used in a part of the OptiPrem project (Workstream 3). This workstream evaluates the cost of care for all preterm babies born between 27-31 weeks in England, up to the time they reach two years of age. It will look to see whether it is cost effective to be born and looked after in one of two types of neonatal units: a neonatal intensive care unit (NICU) or a local neonatal unit (LNU). It will see assess whether this influences the longer-term cost of medical care up to two years of age). The dataset for this project is called The OptiPrem dataset and comes from the NNRD. With the NHS England Data, the study team looked at Hospital Episode Statistics Outpatients, Hospital Episode Statistics Critical Care, HES: Civil Registration (Deaths) bridge, Civil Registration (Deaths) - Secondary Care Cut, and Hospital Episode Statistics Admitted Patient Care. This analysis includes calculating the cost of care from daily episodes of care for each baby in each gestational age group, and comparing the overall costs of care for those babies born in a Local Neonatal unit, and those babies born in a neonatal intensive care unit (two types of units). It is important to note that the economic cost of care forms just one stream of the entire project. The project evaluates best place of care based on key clinical outcomes i.e mortality and major morbidity. These are being undertaken in different workstreams that do not require NHS digital linkage and are not part of this application. In the event that there is no difference in place of care, based on the key clinical outcomes, then the economic cost of care will be used to define recommendations nationally, together with parent staff perceptions (separate workstream). Justification for the work- how NHS England linkage assisted the OptiPrem project aims: The NNRD only captures neonatal admission data (this usually lasts a few weeks for babies born in this age group 27-31 weeks). This project looks at outcomes (hospital admissions, critical care, out-patient visits, and deaths up to two years of age) and works out the costs associated with this care. The OptiPREM study team at University of Oxford need NHS Digital data because it has data that covers the two-year time point that is needed; this is not available via the NNRD. • Linking NHS England Data on each baby from the time of birth, through discharge from a neonatal unit (i.e. NNRD held information on babies born between 27-31 weeks gestation in England), to hospital episodes statistics and mortality up to two year of age for each baby (i.e. NHS England records) helps to assess costs of care using population-based outcomes up to 2 year of age, in workstream 3 of the OptiPrem project. The OptiPREM study team at University of Oxford will use the NNRD data to calculate costs of care while the baby is an inpatient on the neonatal unit (captured on NNRD and not on NHS digital), and the NHS Digital HES and mortality data will be used to calculate the cost of care after the baby is discharged from the neonatal unit up to time of death or two years of age (this is captured on NHS digital HES/Mortality). • Linking neonatal patient records to subsequent HES patient records and civil registration mortality Data up to two years of life enables the OptiPrem research team make a reasonably informed decision on what impact the place of care at birth or neonatal period has, on the subsequent mortality and hospital episodes needed for babies born between 27 and 31 weeks. This enables the organisation to examine post discharge morbidity, resource utilization, readmission rates and secondary care activity. This work aims to set standards for the country on where babies should be born and cared for between 27-31 weeks gestation. The OptiPREM team will be utilising the data from NHS Digital (HES and mortality), linked to the OptiPrem cohort babies (27-31 weeks gestation) in the OptiPrem dataset. The cohort is all babies born with a gestational age between 27+0 weeks and 31+6 weeks at birth,and discharged between the time periods 01 January 2014 to 31 December 2018 in England. The OptiPREM team based at University of Oxford will calculate the cost of care for babies born at each gestational age (i.e. 27, 28, 29, 30, 31 weeks) and for each type of unit (i.e. Local Neonatal Unit vs Neonatal Intensive Care Unit) while they are in hospital in a neonatal unit (i.e. the first few weeks of life), using NNRD data, and then after they are discharged from the neonatal unit, and are seen at hospital/outpatient clinic/critical care/ etc up to time of death or two years of age, whichever comes first. For the latter data from NHS Digital will be used. In order to work out the cost of this care after discharge from the neonatal unit , the OptiPREM team will need to have a link between each baby born in this gestational age group, and their HES and Mortality record, held at NHS Digital. This information will be linked using their identifiers such as NHS number. With the NHS Digital data, the team will be looking at Hospital Episode Statistics Outpatients, Hospital Episode Statistics Critical Care, HES: Civil Registration (Deaths) bridge, Civil Registration (Deaths) - Secondary Care Cut, and Hospital Episode Statistics Admitted Patient Care. This analysis will include calculating the cost of care from daily episodes of care for each baby in each gestational age group, and then comparing the overall costs of care for those babies born in a Local Neonatal unit, and those babies born in a neonatal intensive care unit (two types of units). Justification for the work- how NHS Digital linkage will help OptiPrem project aims: • Linking NHS Digital data on each baby from the time of birth, through discharge from a neonatal unit (i.e. NNRD held information on babies born between 27-31 weeks gestation in England), to hospital episodes statistics and mortality up to two year of age for each baby (i.e. NHS digital records) will help to assess costs of care using population-based outcomes up to 2 year of age, in workstream 3 of the OptiPrem project. • Linking neonatal patient records to subsequent HES patient records and civil registration mortality data up to two years of life helps the OptiPrem research team make a reasonably informed decision on what impact the place of care at birth or neonatal period has, on the subsequent mortality and hospital episodes needed for babies born between 27 and 31 weeks. This will also help the organisation examine post discharge morbidity, resource utilization, readmission rates and secondary care activity. This work will help set standards for the country on where babies should be born and cared for between 27-31 weeks gestation. [1 paragraph unchanged] The OptiPREM study has 5 workstreams and seeks to address best place [23 words unchanged] two years of age and socio-ethnographic analysis. Workstream 3, which studies the socio economic socio-economic cost of care up to two years of life, requires linkage to NHS Digital, England, for the reason stated above. [1 paragraph unchanged] The Royal Wolverhampton NHS Trust (RWT) is the sole data controller for this project working on linked HES, Mortality and OptiPREM data. RWT was awarded the grant and is the OptiPREM study sponsor and outsources the expertise from NDAU and the University of Oxford for data management and analysis respectively. The grant has been awarded to the Royal Wolverhampton NHS Trust, and the project is managed through its chief investigator, at the Royal Wolverhampton NHS Trust. All decision making around results, recommendations and outputs will be led by the Royal Wolverhampton NHS Trust. The Royal Wolverhampton NHS Trust (RWT) is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. Organisations which are analysing and preparing the data in this NHS Digital Linkage request The lawful basis for processing personal data under the UK GDPR is: University of Oxford: Data processor who will be conducting the health economic analysis for this linked data between NHS digital (HES/mortality) and the NNRD OptiPrem dataset on behalf f the data controller. Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. The Neonatal Data Analysis Unit (NDAU): Data processor, and will be a) forming the OptiPrem dataset using the NNRD, b) will send OptiPrem dataset identifiers for the NHS digital linkage, and c) append the NHS digital HES/mortality data to the rest of the OptiPrem dataset. The lawful basis for processing special category data under the UK GDPR is: LEGAL BASIS AND ETHICS: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The legal basis for processing personal data under GDPR, is to perform a task in the public interest. This is covered under Article 6(1)(e); - The Royal Wolverhampton NHS Trust (RWT) are both public bodies, and it is in the public interest that work is done into providing details on mortality rates. The personal data requested under this agreement includes information about a participant's health; these are considered as special category data, and therefore the legal basis for processing these data is processing required for scientific research purposes which is covered under Article 9(2)(j) of the GDPR. The funding is provided by the National Institute for Health Research (NIHR) under the Health Systems (HS) and Delivery Research (DR) programmes . The funding is specifically for the workstreams described. Relevant Ethics approval for OptiPrem, NDAU and NNRD: The project is funded by the National Institute for Health Research Health Systems and Delivery Research (NIHR HS&DR) stream Project number 15/70/104) and ethical approvals are in place (IRAS Reference No 212034). The University of Oxford is a processor acting under the instructions of The Royal Wolverhampton NHS Trust. The University of Oxford's role is limited to data analysis. The University of Oxford conducted the health economic analysis for the linked data between NHS England (HES/mortality) and the NNRD OptiPrem dataset on behalf of RWT. The NDAU has Research Ethics Approval (REC Reference: 16/LO/1093) and Confidential Advisory Group (CAG) approval (ECC8-05(f)/2010 for the creation of the NNRD. Imperial College London is a processor acting under the instructions of The Royal Wolverhampton NHS Trust. Imperial College London's role is limited to data management. Imperial College London performed three functions: The NNRD is hosted on secure Chelsea and Westminster NHS Foundation Trust servers within the Chelsea and Westminster Campus of Imperial College. The NDAU extracts the data for the OptiPrem dataset from the NNRD, using these servers. The NDAU (who prepares the OptiPrem dataset) is a section within Imperial College of Science, Technology and Medicine. The team at NDAU working on the OptiPrem dataset (and supporting the NHS digital linkage) are substantive employees of NDAU, at Imperial College. a) forming the OptiPrem dataset using the NNRD There is no separate individual consent process as this project captures data on approximately 29000 babies. Linkage of the OptiPREM data and NHS Digital data is covered by section 251. Ethical approvals for the data linkage are covered by IRAS 212034. b) sending OptiPrem dataset identifiers for the NHS England linkage c) appending the NHS England HES/mortality Data to the rest of the OptiPrem dataset. The NNRD is hosted on secure Chelsea and Westminster NHS Foundation Trust servers within the Chelsea and Westminster Campus of Imperial College. The NDAU extracts the data for the OptiPrem dataset from the NNRD, using these servers. The NDAU (who prepares the OptiPrem dataset) is a section within Imperial College of Science, Technology and Medicine. The team at NDAU working on the OptiPrem dataset (and supporting the NHS England linkage) are substantive employees of NDAU, at Imperial College.

Processing activities

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data)” To facilitate data linkage, Imperial College London (ICL) submitted patient level data using the NHS England Secure Electronic File Transfer service for babies born at 27 to 31 weeks and discharged from neonatal care between 2014 and 2018 from the Neonatal Data Analysis Unit, for linkage with HES and mortality Data. The following identifiers were submitted to NHS England using the NHSE Secure Electronic File Transfer service: To facilitate data linkage, there will be a secure data submission of patient level data for babies born at 27 to 31 weeks and discharged from neonatal care between 2014 and 2018 from the Neonatal Data Analysis Unit to NHS Digital for linkage with HES and mortality data. The following identifiers will be submitted: [6 paragraphs unchanged] Linkage of the dataset cohort to HES and mortality data shall solely be done Data was completed by NHS digital. England. NHS Digital will supply England supplied an extract of linked data pseudonymised Data for these babies (Study ID + HES + mortality data) Data) back to NDAU. NDAU at ICL. This will include data included Data for babies discharged from neonatal units between 01/01/2014 and 31/12/2018 and will include data included Data up to the second birthday for each baby included in the study. The data requested covers Data was provided as one dissemination of HES and mortality data from Data for the period 2013/2014 - 2019/2020 2019/2020, and 2020/2021 HES and mortality Data was provided in one a later dissemination and data from 2020/2021 in another dissemination. when the Data became available. This data will Data sufficiently capture captured all post neonatal events for up to 2 years for each date of birth for every baby in OptiPREM. At NDAU the HES + Mortality linked data will be was downloaded and there after shall be appended to the rest of the OptiPrem variables via Study ID to form a linked HES + Mortality + OptiPrem dataset. The Study ID, which was created only for the sole purpose of linkage, will be is used to trace back to the first unique identifier for each baby, a pseudonymised NHS number. Once this trace is was complete, the Study ID will be dropped, was removed from the linked dataset, this linked pseudonymised HES + Mortality + OptiPrem datatset will was then be sent to the OptiPrem health economic team at the University of Oxford for data analysis. There will be no un-encrypting or decrypting requirement and no attempt to reidentify babies, individuals when using the Data. The team at NDAU will only use used the Study ID to trace back to original unique identifier, the pseudo anonymised NHS number ID for each baby. This will allow allowed the team at NDAU to present NHS Digital data England Data with pseudonymised NHS number for baby identification. As stated earlier, this is what is well understood as a baby identifier with the OptiPREM study team. Neonatal Data Analysis Unit transfers identifying data in an encrypted file sent over a file exchange system, with the password sent separately. After linkage, NHS Digital sends England sent linked data Data to NDAU over secure electronic file transfer. using the NHS England Secure Electronic File Transfer system. All identifying data is removed by NHS Digital. This England. The linked data is Data was then downloaded vis secure electronic file transfer via the NHS England Secure Electronic File Transfer system and loaded on a secure Chelsea and Westminster Hospital NHS Trust server. The data request Data held is limited and restricted to a cohort containing babies born in England [7 words unchanged] and discharged out of neonatal care between 2014 and 2018. The records requested held are limited minimised to only be from date of discharge from neonatal care up to [7 words unchanged] for the selected cohort. Only HES admitted, critical care, out-patient and mortality data Data products are were requested, as these will contain the paediatric records for the selected cohort. Only annual refreshes from 2013/2014 to 2020/2021 are requested, were provided, as these will contain the relevant records of up to the second birthdate of the last discharged OptiPrem baby on 31st December 2018. HES/Mortality Data submitted provided by NHS digital will then be England was appended to OptiPrem dataset to link it and thereafter sent as an encrypted file over the a secure file exchange system to the OptiPrem health economic team at the University of Oxford, with password sent separately. [1 paragraph unchanged] The cohort is all babies born with a gestational age between 27+0 weeks and 31+6 weeks at birth,and birth, and discharged between the time periods 01 January 2014 to 31 December 2018 [6 words unchanged] 2 years from the date of birth for individuals in the cohort. Dataset: Datasets: The NHS England provided the OptiPREM study team request to only obtain data from have limited to only get data from Hospital the following datasets under a previous iteration of this agreement: Episode Statistics (HES) Outpatients, Outpatients; Hospital Episode Statistics Critical Care, Care; HES: Civil Registration (Deaths) bridge, bridge; Civil Registration (Deaths) - Secondary Care Cut, and Cut; and, Hospital Episode Statistics Admitted Patient Care. The OptiPREM study team believes will capture data for the paediatrics, when compared to the rest of the datasets like HES Accident and Emergency. [1 paragraph unchanged] In this request, the The OptiPREM study team has limited the number of years to 2013/2014, 2014/2015, 2015/2016, 2016/2017, 2017/2018, 2018/2019 [22 words unchanged] age of each discharged out of neonatal care between 2014 and 2018. [1 paragraph unchanged] The request focuses focused on records for those babies that were born and admitted in England and at 27 to 31 weeks of gestation. [1 paragraph unchanged] All episodes falling between 2014 and 2020 2021 are essential to measuring clinical outcomes and cost of care each discharged out of neonatal care between 2014 and 2018. [1 paragraph unchanged] Not all fields have been were chosen, as some do not apply to paediatrics, i.e. alcohol related variable. [29 words unchanged] (LSOA)is sufficient, instead of using all the rest of the geography fields. [1 paragraph unchanged] The requested data will be Data was linked data for to only those supplied by the NDAU to NHS Digital. England. NDAU will supply supplied identifiers for a cohort of approx approximately ~26000 to 29000 babies. There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement. No other linkage of NHS England Data was undertaken. Only linkage described in the Agreement was undertaken. Data will only be is processed by substantive employees of the processors listed in this agreement.

Expected output

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide [3 paragraphs unchanged] This project will include a recommendation component (workstream 5) that will tie up all the findings in the project, including that if workstream 3, which uses NHS Digital England linked data. Data. [2 paragraphs unchanged] The output from the study will be shared via social media, presentations, [9 words unchanged] are likely to shape service delivery for neonatal units around the country. Expected target date for publication output in relation to data linkage is December 2021. This will allow adequate time for analysis of the last set of data from babies completing their 2nd birthday by December 2020. Preliminary output for Workstream 3 linked data in the form of presentations, workshops and discussion forums will begin around August 2021. [4 paragraphs unchanged] It is expected recommendations may be available after completion of data analysis including the two-year data linked to NHS digital. England. It is expected recommendations may be available after completion of data analysis including the two-year data linked to NHS digital. Outputs from this may be evident by late 2023/2024 and the study team may have to return to NHS England to attend to reviewer comments. Output from this may be evident by late 2021 and early 2022. Findings from WS1 will inform the analysis of nhs hospital utilisation and outcomes for babies with SBI and BPD to assess impact of place of care on NHS costs up to 2 years of life. Publications to date: 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(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(8):e029421. Ismail AQT, Boyle EM, Pillay T, OptiPrem Study G. 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(1):e000583. Ismail AQT, Boyle EM, Pillay T. Clinical outcomes for babies born between 27 – 31 weeks of gestation: Should they be regarded as a single cohort? Journal of Neonatal Nursing. 2022. 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(4). Cupit C, Paton A, Boyle E, Pillay T, Armstrong N, Team O-PS. 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(6):e059428.

Expected measurable benefits

The first results for this study are were expected within a year of the download of the NHS digital England linked two-year data. The OptiPREM study will hopefully lead Whilst some outputs have been achieved, there have been delays due to recommendations which may have an impact on the following categories. COVID and changes in staffing. The OptiPREM study will hopefully lead to recommendations which may have an impact on the following categories. [26 paragraphs unchanged] SBI findings are likely to change service delivery for country for babies born at 27 weeks.

Benefits reported

Yielded Benefits is not a requirement for new applications. The results of Opti-prem are now being published and information on how it can shape future service delivery being developed. The study team have identified an increase in serious brain injury in babies born at 27 weeks at LNU and this information is informing health service delivery discussions on best place of care for babies born at 27 weeks gestation in England. The study team have also identified costs of care and cost effectiveness of care to one year. The study identified a preliminary association with quality of care and this will be studied in more detail over the coming year through additional projects. Parent perspectives on place of care have been captured, which will guide overall service delivery. The study team are now pending submission of the NIHR draft report, the morbidity and mortality outcomes and cost effectiveness analysis.