Investigating the impact of London’s Ultra Low Emission Zone on children’s respiratory health: evidence from NHS health records CHILL-HR: Children’s Health in London and Luton: Health Records Study NIHR Public Health Research Programme, Project Reference Number: 16/139/01

Queen Mary University of London (QMUL) requires access to NHS England data for the purpose of the following research project:

Investigating the impact of London’s Ultra Low Emission Zone on children’s respiratory health: evidence from NHS health records: Children’s Health in London and Luton: Health Records Study (CHILL-HR)

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

Air pollution is the greatest environmental threat to health in the UK. Each year it contributes to 30,000 deaths in people under the age of 75 and costs our economy £20 billion. Childhood and adolescence are periods of rapid growth when organ systems are susceptible to damage from traffic-derived air pollution.

The UK government has committed to reduce the amount of particulate matter (PM), a harmful component of air pollution, in the air we breathe to meet the World Health Organisation’s guidance. Clean Air Zones (CAZ), areas where targeted action is taken to improve air quality, are increasingly planned across the world. However, we do not know what effect these CAZs have on air pollution levels or health. The London Ultra Low Emission Zone (ULEZ) was introduced on 8 April 2019, covering initially only Central London. From 2021 it covers a larger area inside the North and South circular roads that is home to 3.8 million people. From 29 August 2023, the ULEZ expanded across all Greater London, that is home to additional 5 million people.

CHILL is a prospective two-arm parallel cohort study to determine what is the impact of a large-scale public health intervention – ULEZ – compared to no-intervention on lung growth, respiratory health, cognitive function and mental health, school attendance, parent work productivity and use/costs of healthcare services and Quality of Life of primary school children.

The primary research question QMUL aims to answer is:

• Do air quality improvements delivered through the introduction of the Ultra-Low Emission Zone in Central London improve the health of children growing up in highly trafficked urban environments, as judged by NHS health record data of CHILL study participants?

Secondary objectives are to:

• Assess value for money by undertaking a cost consequence analysis.

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care

o Accident & Emergency

o Critical Care

o Outpatients

• Emergency Care Data Set (ECDS)

• Medicines dispensed in Primary Care NHS Business Services Authority

These datasets are required to assess the impact of air pollution and London’s ULEZ on child health outcomes. In addition, these datasets are also required to capture a comprehensive record of healthcare use that, together with national reference costs, enables the assessment of children’s healthcare and prescription costs, a key component of the economic evaluation of London’s ULEZ.

The level of the Data will be Identifiable.

The Data will be minimised as follows:

• Limited to a study cohort identified by QMUL – This consists of 1,964 primary school children in London and Luton who have been recruited through parental consent, who meet the following inclusion criteria:

1. Primary schools within, or with catchment areas that include, the Central London ULEZ.

2. Primary schools within the Borough of Luton and town of Dunstable.

3. State or independent sectors.

4. Children attending a study school, in years 2, 3, or 4, at study inception.

• Limited to data from point of child’s birth to 2023/24.

QMUL 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.

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.

Air pollution negatively affects health across the life-course, and children and adolescents residing in urban areas are particularly vulnerable to the harmful effects of air pollution. These health effects including pre-term birth, asthma incidence and exacerbation, eczema, and mental health problems in adolescence and increased risk of poor health and premature death in adulthood. Thus, the purpose of this processing is to bring robust evidence on the health and economic impact of clean air zones as an intervention to prevent these harms, to inform public health policy on implementation of air quality interventions across the UK.

The funding is provided by the National Institute for Health and Research. The funding is specifically for the study described.

The Independent Scientific Committee (ISC) oversees the CHILL study, ensuring the highest standards of robust scientific research. The ISC is chaired by a prominent, internationally respected scientist; members are drawn from public and scientific organisations. The ISC meets on an annual basis. Three members of the public, who are advisors to the project, are invited to attend the ISC.

Data will be accessed by:

a) Undergraduate, Masters, or PhD students enrolled with QMUL. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to QMUL policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of QMUL. QMUL would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA.

b) Individuals holding an honorary contract under the supervision of a substantive employee of QMUL for the purposes described in this DSA only. QMUL must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

a. Their substantive employer;

b. Their role in respect of the purpose for the processing specified in the DSA;

c. The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

d. The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

e. Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

A Public and Patient Involvement and Engagement (PPIE) group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above. The role of the PPI group is to ensure that the perspectives and welfare of the participant children, parents and schools remain at the centre of the study throughout. The PPIE group will provide comment and advice on study materials, support recruitment and retention in the study, and advise on dissemination of progress and findings. The PPIE group will be informed of study progress by the Project Management Group (PMG), and PPIE group members will be invited to join PMG meetings as required.

QMUL will transfer data to NHS England. The data will consist of identifying details including NHS Number, Date of Birth, Gender, Forename, Surname and a unique person ID for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES/ECDS & Medicines dispensed in Primary Care (NHSBSA data) datasets to QMUL. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

QMUL will extract a subset of the Data comprised of linked study collected data, modelled air quality exposure data, and HES data for each participant and securely transfer this to North West London (NWL) NHS Secure Data Environment for analysis.

The Data will be stored on SMD Barts Cancer Centre (BCC) Data Safe Haven at QMUL.

The Data will be accessed by authorised personnel via remote access.

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. Only authorized individuals will have access to the data.

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;

- 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 DSA) 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).

Remote processing will be from secure locations within England. The data will not leave England/Wales at any time.

Data will be accessed by individuals with an honorary contract with QMUL. The individuals will act as an agent of QMUL at all times under supervision from employees of QMUL. Aside from these individuals, access is restricted to employees of QMUL who have authorisation from the Chief Investigator.

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

The Data will be linked at person record level with CHILL cohort study collected data, air pollution exposure data, and primary care record data obtained from TPP, EMIS, and Discovery Data Service.

Across these primary care data providers, participant primary care records will be obtained via TPP service data extraction for patients attending practices in Bedfordshire, Luton and Milton Keynes Integrated Care Board (ICB); via EMIS Explorer service for patients attending GP practices in North Central London and South West London ICBs; and via Discovery Data Service for those attending GP practices in North West London, North East London, and South East London ICBs.

The Data will be linked with publicly available data including Index of Multiple Deprivation from GOV.UK (https://www.gov.uk/government/statistics/english-indices-of-deprivation-2019). To assess the value for money of the ULEZ each hospital attendance or hospital episode recorded in HES will be mapped to a Healthcare Resource Group (HRG) and appropriate NHS reference costs will be applied to value hospital resource use and estimate hospital care costs. In parallel, part of the economic evaluation will include the income/productivity loss due to parental work absence related to the participant’s ill health, to this extent the data will be linked with data from the Annual Survey of Hours and Earnings (ASHE) of the Office of National Statistics (ONS).

Researchers from the CHILL study team at QMUL will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to the funder (NIHR), which will be targeted for Spring 2025.

• Submissions to peer reviewed journals which will be targeted for Summer/Autumn 2025.

• Presentations to study stakeholders

• Presentations at appropriate conferences

• Short videos to convey results to the public and study participants

• Publication of study findings on partnership organisation’s websites

• Policy briefings to NHS and government bodies

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.

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

• Journals

• Webinars open to study participants, peer supporters, primary and secondary care staff, and organisations such as the Committee on the Medical Effects of Air Pollutants (COMEAP) and the Tackling Air Pollution at School (TAPAS) network (https://tapasnetwork.co.uk/).

• Social media

• Briefing documents provided to study participants, CHILL primary and secondary schools, peer supporters as well as primary and secondary care staff.

• Public events – QMUL will present the work at scientific meetings, and congresses. For example, the European Respiratory Society (ERS) Congress.

• Press/media engagement

• Public promotion of the research by disseminating aggregated findings through the mainstream media (e.g. BBC news, Channel 4 News, Times Newspaper etc.)

• Participant school newsletters

• Reports aimed at Urban Managers and City Planners to be aware of the negative effects of air pollution

- Final Report to Funder: Autumn 2025

- Peer Reviewed Publications: Autumn/Winter 2025

- Conferences and meetings: Autumn/Winter 2025

- Media 2023 - Ongoing

The findings of this research are expected to contribute to evidence-based decision-making for UK government, international government; NHS policymakers, local decision-makers including NHS Integrated Care Boards; and patients and patient advocacy groups to inform best practice, particularly for vulnerable patient groups.

Specifically, the team expect to show:

• Reductions in the incidence of diseases, for example new cases of asthma, incidence of poor mental health

• Reductions in the incidence of consequences of diseases, for example asthma attacks

• Reductions in health care utilisation and NHS and social care costs

• Improvements in quality of life

The team will also provide evidence on the city-wide impacts of introducing a Clean Air Zone – evidence that will inform UK governments and local government transportation and health policy, and city planning policy globally.

The use of the data could:

• 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 the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

• inform planning health and care services and programmes, for example to improve equity of access, experience and outcomes via universal services provided by health visitors, GPs and school nurses.

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

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

These expected benefits to health and social care are achievable through the dissemination and impact strategy developed by an interdisciplinary team at QMUL and our partner institutions, Imperial College London and the University of Edinburgh.

The team will share CHILL study findings via a video series highlighting key findings, online webinars, a stakeholder event for local and regional leaders and related investigators, regular parent and school newsletters, website and social media content, local public engagement events, and policy briefs for local and national policy influencers on the impacts of Clean Air Zones on children’s health.

In addition, the team will prepare brief reports for each London ICB region and Luton Primary Care Network to highlight findings and relevance to the local area, to provide local healthcare policy makers and primary care practitioners with evidence of the benefits of minimising exposure to air pollutants. The CHILL Health Records study will also strengthen the role of the primary care practices in advising patients on the health and welfare risks of poor air quality.

There are no yielded benefits thus far, as the study is ongoing. The analysis will commence as soon as the data from v1.0 is released.