Trends in the Prevalence and Complexity of Children with a Life-Limiting or Life-threatening Condition in England

King’s College London (KCL) requires access to NHS England data for the purpose of the following research project:

Trends in the Prevalence and Complexity of Children with a Life-Limiting or Life-threatening Condition in England

The following is a summary of the aims of the research project provided by KCL:

Life-limiting conditions (LLC) are serious health conditions in which the child's life may be shortened. From a previous study using Hospital Episode Statistics (HES) data, it was estimated that 86,000 children (0 – 19 years) lived with an LLC in England in 2017/18. Children living with an LLC usually have repeated admissions to hospitals and require healthcare including palliative care for many years. Having up to date data is pivotal for service planning and provision.

One challenge in the field is the lack of information on the severity or complexity of the child’s condition. This could be assessed using key features like the number of health conditions and the use of medical technologies and problem severity by children’s clinical stages. Availability of community prescribing data in England along with data on hospital admission and emergency department attendances would enable KCL to update the national prevalence of children and young adults living with LLC in England and to determine their clinical condition and complexity to aid service planning and delivery. Prevalence will be calculated as an overall total per 10,000 and stratified by age group, diagnostic category, ethnicity, and deprivation category. An assessment on the complexity of a child’s or young adult's condition will be calculated, considering the number of prescription medications and the disability complexity scale (considering primary diagnosis, the number of other diagnoses, the use of medical technologies and number of medications taken). Children and young adults aged up to 25 years have been included in this research project to include the transition to adult services and to allow comparison with recent data analyses from Wales.

Specific Objectives:

1. To assess the trends in the numbers of and prevalence of children and young adults with a life-limiting condition in England from 2003-2022

2. To assess the complexity of children and young adults with a life-limiting condition and the trends over time in this complexity

3. To assess the proportion of children with polypharmacy that may result in safety concerns

4. To describe the number and prevalence of children and young adults with a life-limiting condition at Integrated care board (ICB) level

5. To model future national prevalence of children and young adults with an LLC utilising the ethnic specific population projections (2023/2035)

6. To describe the population of children seen by consultants in Paediatric Palliative Medicine

The following NHS England data will be accessed:

• Hospital Episode Statistics

> Admitted Patient Care (APC) – necessary to identify the cohort of interest and to assess healthcare use.

> Accident & Emergency (A&E) – necessary to assess healthcare use – one measure of complexity.

• Emergency Care Data Set (ECDS) – necessary to assess healthcare use – one measure of complexity.

• Civil Registration Mortality – necessary to assess the number and place of death in this population.

• Medicines Dispensed in Primary Care (NHSBSA) – necessary to assess medication use in the form of polypharmacy – one measure of complexity. This group of children have very complex needs - understanding their use of medication i.e. combinations required is crucial to understand the effectiveness of these medications in this group. It is important to understand the use of medications in this very vulnerable population especially in relation to outcomes. The use of the NHSBSA data will enable the patterns of prescribing in the population of children and young people with life-limiting conditions to be described, in relation to their complexity, and contribute to intelligence about the safety and effectiveness in this population. The proportion of children who are taking multiple medications (polypharmacy) will be calculated. Polypharmacy has been shown to be associated with increased safety issue of medication i.e medication errors, drug interactions and increased side effects.

Sensitive data required:

> Ethnic category: The prevalence of life limiting conditions is higher in children from non-white ethnic backgrounds. Sensitive ethnic category data is required to assess the prevalence of children with LLC in ethnic minority groups.

The level of the data will be:

> Pseudonymised

The data will be minimised as follows:

> Limited to a study cohort identified by NHS England as meeting the following criteria: Patients between 0-25 years who have a life-limiting or life-threatening ICD 10 code OR a palliative care treatment/speciality code in HES APC. Only individuals aged up to 25 years have been included to include the transition to adult services and to allow comparison with recent data analyses from Wales – see https://www.hopehouse.org.uk/trends-report

> Limited to data between 01 January 2003 to latest available, or until date of death, whichever comes soonest. This is to allow KCL to analyse data from birth to young adulthood.

> The quantum of data requested is the minimum necessary and could not be further reduced without impacting the ability to achieve the stated aims. 20 years of data are required to:

- align and enable comparison with previous studies using HES data

- understand trends in this population over time

- model future prevalence. As long a time period as possible is required as this data are used in the statistical models of future prevalence

King’s College London (KCL) 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. KCL also process the data.

The coinvestigator for the study is employed by the University of York. The University of York do not process the data, and do not influence the purpose or means of data processing and will not carry out any controllership activities.

NHS England has commissioned KCL to undertake the work. NHS England does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by KCL.

The lawful basis for processing personal data under the UK GDPR is:

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 lawful basis for processing special category data under the UK GDPR is:

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, in the University's capacity as a public authority, the research undertaken will be in the public interest as the outcomes of this study are expected to quantify the effects of current healthcare practices, identify the impact on those affected and have the potential to improve healthcare by aiding service planning and provision.

The funding is provided by NHS England. The funding is specifically for the project described. Funding is in place until December 2023.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Studies assessing the numbers of children with life-limiting conditions and the importance of these data for planning services have been discussed with the Family Advisory Board members of the Martin House Research Centre (www.york.ac.uk/mhrc) several times. The parents were supportive of the research and stated they wished that data were shared to inform the care of their children. This group will be consulted with initial study findings to help with interpretation and dissemination.

No data will flow to NHS England for the purposes of this Agreement.

NHS England data will provide the relevant records from the HES, NHSBSA, and deaths datasets to KCL. The data will:

> contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at KCL within the King's Computational Research, Engineering and Technology Environment (CREATE) Trusted Research Environment (TRE), which operates via the KCL privately run cloud.

The data will be accessed onsite at the premises of KCL.

The data will also be accessed by authorised personnel via remote access. The data will remain on the servers owned by KCL at all times.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Personnel are both prohibited and technically prevented from downloading or copying NHSE data to local devices;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The data will not leave England/Wales at any time.

Access is restricted to substantive employees of KCL who have authorisation from the Principal Investigator.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the data.

Researchers from KCL will analyse the data for the purposes described above.

The expected outputs of the processing will be:

> A report of findings to NHS England as funder (expected once, at the end of the study)

> Submissions to peer reviewed journals such as Archives of Disease in Childhood, British Medical Journal (BMJ) Supportive & Palliative Care, Palliative Medicine (approx. 12-18 months after receipt of data)

> Presentations at appropriate conferences

> Presentations at the World Research Congress of European Association for Palliative Care and the European Congress on Paediatric Palliative Care

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

NHSBSA data:

The medicines data is not deemed disclosive and information on a GP level is available in the public domain. However, should the published information pose a risk of re-identification, the following suppression methodology should be applied:

· Zeros should be shown.

· 1-7 to be rounded to 5.

· Any other numbers rounded to nearest 5.

· Rounding unnecessary for averages etc.

· Percentages calculated from rounded values.

· If zeros need to be suppressed, round to 5.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Open-source frameworks such as publication on online webpages open to all, e.g., the study website

> Email alerts, including key findings, to key stakeholders, e.g., clinicians, policy makers

> Presentations at appropriate conferences, available to clinicians, academics and members of the public

> Social media such as X (@csi_kcl)

> Briefing documents provided to the clinical leads in all the paediatric palliative care teams, in the UK

The outputs are expected from mid to late 2024. Final outputs will be towards the end 2024. There is then expected to be a period of up to 12-months for peer review

The results of this study may be very important for service planning and resource allocation for paediatric palliative care/children's hospice services, as the study hopes to provide details on the number of patients who require these services and how long they require these services for. Results aim to update the prevalence of children and young people living with LLC in England and provide information on the complexity of the child's condition.

The use of the data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of regional and national trends in health and social care needs.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

The study is expected to lead to recommendations that have an impact on the following areas:

1. impact on children and families

The results of this study hope to impact on children and families by presenting the number of children living with an LLC in England and assessing the stage of their condition, it's complexity and the potential safety concerns over polypharmacy. This knowledge could be essential for recognising children and family needs, which has the potential to support healthcare provision including appropriate and safe medication management. Ultimately, it may help to improve the quality of life for the children and their families.

2. Impact on healthcare services and palliative care teams

Approximately half of all deaths in England and Wales every year are from underlying life-limiting conditions, and children living with an LLC usually have repeated admissions to hospitals and require palliative care for many years. To plan services, it is necessary to understand the population who may benefit from these services. The study hopes to provide the most up-to-date national data, aiding both service planning and provision.

3. Impact on commissioning: service and economic implications for the NHS

The hospital based paediatric palliative care services are NHS funded, with most children's hospice services being provided by the voluntary sector. The data provided from this project hopes to ensure that the future provision of and planning of both NHS and voluntary sector services is based on robust data. Considering the limited resources available, the results of this study may help to identify healthcare usage and costs that could provide guidance for further resource allocation that can maximise the impact on public health.

The impact of this study is expected to be achieved through dissemination of the study findings to the NHS England palliative and end of life care (PEoLC) board, who commissioned this study and will be allocating the children’s hospice grant. Findings will also be shared with all the Integrated Care Boards (ICBs) and through charities including Together for Short Lives.

Not stated in the register.