Critically ill children and young people: do national Differences in access to Emergency Paediatric Intensive Care and care during Transport affect clinical outcomes and patient experience? The DEPICT study

Critically ill children who are admitted to district general hospitals can require specialist transport to a paediatric intensive care unit (PICU). There is considerable variation in the care provided to critically ill children prior to admission to paediatric intensive care. It is unclear whether the differences in timeliness of access to paediatric intensive care, and care delivered during stabilisation and transport by specialist transport teams have an impact on clinical outcomes or in terms of the cost of transportation and subsequent care, and patient's quality of life. The primary objective of the DEPICT (Differences in access to Emergency Paediatric Intensive Care and care during Transport) study which is covered by the initial Data Access Request is to study the association between timeliness of access to paediatric intensive care and 30-day mortality. A further workstream of the DEPICT study (workstream C), included in the original protocol is an economic analysis. The aim of this workstream is to determine the costs and value for money of different models of Paediatric Intensive Care Retrieval Teams (PICRTs) in order to identify cost-effective models of service delivery.

The University of Leicester is the current data holder and they are submitting this amendment in order to use the dataset already held at Leicester for the economic analysis of DEPICT and to extend the current agreement by a further 3 years. Data that has been pseudonymised and linked data for use in the quantitative analysis work stream of the DEPICT Study (IRAS ID: 218569) will be used for the economic analysis.

This amendment requires no additional data just a change of purpose whereby the same data will be used for analysis of health economic outcomes. In addition University of Leicester would like to extend the agreement for a further 3 years. For this amendment Great Ormond Street and the University of Leicester are joint data controllers. Great Ormond Street Hospital in their role as lead for their study, and the University of Leicester in their role as lead for Workstream A and C. No other organisations, including those listed in the study protocol (who are involved in other Workstreams of the study), will have any decision-making powers in relation to Workstreams A and C. No other organisations will have any responsibility for determining the purpose for which or the means by which data is processed for Workstreams A and C, and therefore no organisation other than University of Leicester and Great Ormond Street Hospital will have data controllership over the data provided under this data sharing agreement.

As Sponsor of the study, Great Ormond Street Hospital, through the Chief Investigator, have a responsibility for the conduct of the entire DEPICT study including Work streams A and C. The University of Leicester are essentially carrying out the data analysis of the linked data set, therefore will decide how the data is analysed. They will receive the study data and store it. Great Ormond Street Hospital will not receive or have access any data that has been received from NHS Digital.

To undertake the analysis specified in the health economic workstream (Workstream C), two health economists with honorary contracts at the University of Leicester will have access to pseudonymised linked data on site only. The sources of data are:

1) Paediatric Intensive Care Audit Network (PICANet) audit data from the University of Leeds. This audit is commissioned by the Healthcare Quality Improvement Partnership (HQIP) and University of Leeds is a data processor for the audit data. There has and will not be any involvement from University of Leeds or HQIP in the design or performance of the DEPICT study, in the study itself or this agreement.

2) Case Mix Programme (CMP) audit data from Intensive Care National Audit and Research Centre (ICNARC). There has and will not be any involvement from ICNARC in the design of the DEPICT study, in the study itself or this agreement.

3) Hospital Episode Statistics from NHS Digital.

4) Civil Registration mortality data from NHS Digital.

5) Patient Episode Database for Wales (PEDW) data from NHS Wales Informatics Service (NWIS).

For both the audit datasets (PICANet and CMP), the University of Leicester approached HQIP and ICNARC to access and process their audit data for the purpose of Workstream A of this study, and this access has been agreed. This application has been updated to include Workstream C in addition to the original Workstream A. Neither HQIP, ICNARC nor the University of Leeds have had or will have any further involvement in this study and, therefore, play no role in the design or performance of the project, and do not have access to any of the data to be disseminated by NHS Digital under this agreement. They will, however, receive study IDs only from the University of Leicester.

The legal basis for dissemination is:

- GDPR Article 6(1)(e) task in the public interest.

- GDPR Article 9(2)(j) scientific research.

The DEPICT study is funded by the NIHR HS&DR programme (ref: 15/136/45) to study the relative cost effectiveness of the PICRT transport team and evaluate alternative methods of service delivery, and provide evidence for the development of future clinical standards.

Under this agreement, the only organisation permitted to access and process the data provided by NHS Digital is University of Leicester.

The data flows are as follows:

1) Data flows to NHS Digital

University of Leeds (PICANet) and ICNARC (CMP) will each securely transfer a file to the NHS Digital Data Access Request Service (DARS). These files will contain person-identifiable information (NHS Number, sex, post code, date of birth) and unique study identifiers (PICANet: DEPICT Study Number; CMP: CMP identifier) required to perform the data linkage.

2) NHS Digital will identify common records between PICANet data and CMP data

3) Data flows from NHS Digital

- NHS Digital will supply a list of the study identifiers common to PICANet and CMP to University of Leicester

- NHS Digital will provide HES data for all individuals in the PICANet cohort to the University of Leicester. The unique study identifiers (DEPICT study number and CMP identifier, where applicable) will be appended to the end of every episode record provided to the University of Leicester.

- Mortality data for all individuals in the PICANet cohort will be provided to the University of Leicester. The unique study identifiers (DEPICT study number and CMP identifier, where applicable) will be appended to the end of every episode record provided to the University of Leicester.

4) Data flow from University of Leicester

University of Leicester will securely transfer DEPICT study numbers and the unique CMP study identifiers for the records that were identified as been in common by NHS Digital to University of Leeds and ICNARC respectively. No HES or mortality data or any other personal identifiable data will be transferred. This information is shared so that clinical data for the records in common can be securely transferred from both PICANet and ICNARC to the University of Leicester for inclusion in their analysis.

5) Data flow from University of Leeds (PICANet) and ICNARC (CMP)

University of Leeds (PICANet) and ICNARC will provide clinical data from their respective audits for the specific DEPICT and CMP records in common identified by NHS Digital to the University of Leicester by means of secure transfer. No personal identifiers will be transferred. HQIP are the data controller for the PICANet data with the GDPR lawful basis Article 6(1)(e) and 9(2)(i); ICNARC are the data controller for the CMP data with GDPR lawful basis Article 6(1)(f) and 9(2)(j).

All statistical analyses will be undertaken at the University of Leicester. The complete study dataset will only be accessed by two individuals employed by the University of Leicester for the statistical analyses and two health economists from the research team with honorary contracts at University of Leicester who will analyse the data for the purposes of the health economic outcomes (work stream C) as planned in the study protocol. 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).

The datasets required by the DEPICT Study team from NHS Digital are mortality and HES data. Data will be required from 2012/13 to 2017/18 to allow investigation of mortality and details about re-admission to A&E or hospital up to one year after the initial admission to paediatric intensive care. Data is only required on individuals aged <19 years to follow up children who required paediatric intensive care. There will be no requirement nor attempt to re-identify individuals from the data. National data is required to allow comparison of the different specialist transport services across the country.

The results of all analyses will be published in aggregate form, with small numbers suppressed in line with HES guidance. No identifiable data will be held by the University of Leicester; therefore, no identifiable data will be released. Linked study data provided by NHS Digital will be used by the Workstream A team at the University of Leicester to achieve the primary and secondary study aims, i.e. investigate if differences exist in PICU mortality, or at 30 days, 90 days or one-year post-admission or if differences exist in re-admission to hospital and subsequent care in hospital following discharge.

The DEPICT Study has the relevant Research Ethics and Section 251 approvals. Under this agreement, the only organisation permitted to access and process the data provided by NHS Digital is University of Leicester’.

There will be no data linkage undertaken with NHS Digital data provided under this agreement other than that which is specified.

The identified outputs relate to both workstream A and C of the DEPICT Study.

The results of the study will be disseminated actively and extensively. The research team has strong links with (a) the PICU community via the Paediatric Intensive Care Society (PICS), PICS Study Group (PICS-SG), and the NIHR CRN: Children Clinical Studies Group (CSG) in Anaesthesia, Intensive Care and Cardiology; (b) the PICU Transport community through the PICS Acute Transport Group; (c) the Healthcare Quality Improvement Partnership national audit programme through the Paediatric Intensive Care Audit Network (PICANet) and Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme; and (d) NHS England.

The DEPICT Study team plan to write six peer-reviewed publications related to the study aims. A recent paper describing the background to the DEPICT study was published in Paediatric Critical Care Medicine (Feb 2018). A peer-reviewed publication describing the DEPICT study’s initial findings will be submitted within 12 to 18 months of beginning the work. The intention is to publish the findings in high-impact journals and these will be made open-access. A final report overviewing the entire project will be published in the National Institute for Health Research (NIHR) Health Services and Delivery Research journal (funders of this research) by the end of the study (May 2020).

CLINICIANS AND ACADEMICS: Clinicians in the study steering group will be drawn from relevant transport services in the UK, and will ensure wide dissemination of the results to frontline clinicians. The findings from the work will be presented at national and international conferences, potentially including the Annual Conference of the Royal College of Paediatrics and Child Health, the World Congress of Paediatric Intensive Care, the PICANet Annual Meeting, the Society of Critical Care Medicine Annual Congress, PICS Annual Scientific Meeting, American Association of Paediatrics Conference, the European Society of Paediatric and Neonatal Intensive Care, and British Association of Critical Care Nurses (BACCN). Dissemination at conferences will occur throughout the course of the DEPICT study (2019-2022).

POLICY MAKERS: Recommendations for clinical guidelines arising out of the research will be published and disseminated to professional societies concerned with the care of children presenting with acute illness, including PICS and the Royal College of Paediatrics and Child Health. The research team's strong links with service managers and NHS commissioners will allow their findings to be disseminated to national policy makers, especially through the PIC Clinical Reference Group. Presentation slides will be prepared for use by the study team or others in disseminating the research findings. The timescale for this will also be throughout the course of the DEPICT study (2019-2022).

PUBLIC: The results of the study will be disseminated to patients and their families, facilitated by the co-applicants, members of the research team who have links with PICS and the NIHR CSG, and via The PICANet Families Group who the research team have liaised with already. Findings will be made available via the DEPICT Study website (https://depict-study.org.uk/) which will make all results publicly available. These will also be promoted via social media (Twitter @DEPICT_Study). The research team will ensure that lay summaries are provided (reviewed in collaboration with parents involved in this research). Where appropriate, results will be promoted as press releases. (2019-2022).

Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide

The identified benefits relate to both workstream A and C of the DEPICT Study.

The DEPICT Study addresses an important clinical problem related to the care of acutely ill children in the NHS. The study will provide important information about the differences which may exist between the different paediatric transport services and the outcomes experienced by children. This is particularly important since current national standards from the Paediatric Intensive Care Society (PICS) are expert consensus derived rather than being evidence based.

The main areas of uncertainty addressed by the DEPICT study are:

1. Provision of early, high-quality acute care has been shown to improve clinical outcomes in specific diseases such as paediatric sepsis and head trauma but it is unclear how these findings apply to the vast majority of critically ill children who require stabilisation and transport to a PICU. The research team will examine whether and how timeliness of access to paediatric intensive care and care delivered during acute stabilisation and transport affect clinical outcomes of

critically ill or injured children with a range of diagnoses and pre-existing medical conditions, so that findings can be generalised to all critically ill children.

2. Centralisation of specialist acute care has occurred in several NHS services such as stroke, trauma, and specialist paediatrics. The findings from this research can provide evidence that can be generalised to evaluate other such centralisations. This is especially relevant to questions related to the trade-off between timeliness of access to acute care and provision of high quality cost effective specialist care.

3. Evidence is urgently required to understand whether and how delays in access to paediatric intensive care and variations in the quality of care provided during acute stabilisation and transport affect clinical outcomes. This study will provide definitive outcome information about critically ill children who receive specialist transport to paediatric intensive care. Development of the transport services and their related PICS standards of care have been driven by expert opinion but these have lacked scientific evidence. It will allow different transport services to compare their service with other services in the country, whilst accounting for the differences in populations and sickness of the children they transport, and will identify inequalities in access and timing of care.

The DEPICT study will generate the high-quality evidence necessary to guide the development of future standards of care for the transport of critically ill children and inform decisions about the associated national policy. This work will be completed by the conclusion of the study in 2022.

To date there has been no yielded benefits from this study. University of Leicester are currently undertaking the statistical analysis as outlined in the original application and they anticipate completing the initial statistical analysis in Autumn 2019.