Recording Antimicrobial Resistance during Death Certification in England

University College London (UCL) requires access to NHS England data for the purpose of the following research project:

The AMR-DC study: Antimicrobial Resistance in Death Certification

The following is a summary of the aims of the research project provided by University College London (UCL):

The aim of this project is to calculate the burden of antimicrobial resistance (AMR) on mortality in England. AMR has been declared a top 10 threat to humanity by the World Health Organisation. Precise estimation of the mortality burden of AMR is important, as it raises awareness regarding the magnitude of the problem among relevant stakeholders, including governments and the public. It also allows accurate epidemiological monitoring of drug-resistant infections and correct allocation of resources to address the infections with the highest burden of disease.

Aims

· To describe the burden and trend of AMR-associated mortality in England in the years 2021 through to 2023

· To establish a pathway for public health authorities for calculating AMR-associated deaths in England using routinely collected data

The following NHS England Data will be accessed:

· Hospital Episode Statistics

o Admitted Patient Care

o Critical Care

– necessary to calculate the total number of AMR-associated deaths.

· Civil Registration Mortality – necessary to identify the cohort.

The level of the Data will be:

· Identifiable – identifiers necessary to enable linkage of the data with Second Generation Surveillance System (SGSS) data collected from UK Health Security Agency (UKHSA).

The Data will be minimised as follows:

· Limited to a study cohort identified by NHS England as meeting the following criteria: All patients who had their death registered;

· Between 01/01/2021 and 31/12/2023;

· Limited to the following geographic areas: England

University College London (Great Ormond Street Institute of Child Health) 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.

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 funding is provided by UKHSA. The funding is specifically for the study described. The funder will have no ability to suppress or otherwise limit the publication of findings.

UKHSA is a processor acting under the instructions of University College London (UCL). UKHSA’s role is limited to receiving identifiable data from NHS England, linking it to SGSS data, removing all identifiers, and then sending these data to UCL.

Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL’s Data Safe Haven.

UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

The London School of Hygiene and Tropical Medicine and the British Society for Antimicrobial Chemotherapy are study collaborators and have advised on the study protocol as experts in the field.

Individuals holding an honorary contract under the supervision of a substantive employee of [Organisation (a named controller or processor)] for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

• Their substantive employer;

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

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

• 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;

• 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 group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above. Thirteen PPIE members were consulted through both interviews and questionnaires. PPIE members agreed that this study is important; the need to learn more about drug-resistant infections and protect future generations was emphasized. They agreed that the steps taken by the study team to safeguard patient confidential data were sufficient. PPIE members agreed that the aim of this study justifies temporary access and dissemination of patient identifiable information for the purposes of data linkage. PPIE members agreed that the study poses low risk to patient confidentiality.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the data from the HES and Civil Registrations of Death datasets to UKHSA. The Data will contain directly identifying data items (specifically NHS Number and Date of death) which are required to link the Data at record level with data already held by UKHSA.

UKHSA will extract linked SGSS data comprised of anonymised data and securely transfer the linked data to UCL.

The Data shared directly with UCL will contain no direct identifying data items but will contain a unique person ID which can be used to remove duplicate records.

The de-identified data will be stored on servers at UCL Data Safe Haven.

Amazon Web Services provides cloud hosting services to UCL and will store the data as contracted by UCL. UCL uses offsite data centre services provided by VIRTUS data centre.

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

The University College London (UCL)(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;

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

Access is restricted to individuals within the Great Ormond Street Institute of Child Health department of University College London (UCL); who have authorisation from one of the Principal Investigators. All such individuals are employees or agents of UCL.

Access to confidential patient identifiable data is restricted to employees or agents of UKHSA for the purposes of data linkage for this study only.

Employees or agents of UCL Great Ormond Street Institute of Child Health are permitted to access anonymised data only.

Data will be accessed by individuals with an honorary contract with UCL. The individuals will act as an agent of UCL at all times under supervision from employees of UCL. Aside from these individuals, access is restricted to employees or agents of UCL who have authorisation from one of the Principal Investigators.

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

The Data will be linked at person record level with SGSS dataset obtained from UKHSA.

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

Researchers from UCL will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

· Publications in peer-reviewed journals within 2025 (one or two)

· Conference presentations (oral and poster) within 2025

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:

· Social media

· Website

· Newsletter of the British Society for Antimicrobial Chemotherapy

· Journals

The findings of this research study are expected to contribute to:

· evidence-based decision-making for the management of antibiotic-resistant infections, which have been declared a public health emergency by the WHO.

· better quality evidence to the UK Healthcare Security Agency on the epidemiology and burden of antibiotic resistant infections.

· identifying improvements required in the death certification system with regards to antibiotic resistant infections

· advancing understanding of regional and national trends in mortality from antibiotic resistant infections and assess inequality metrics among patients dying from these infections.

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.

· advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as drug resistant infections.

· 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.

· 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.

It is hoped that through journal and media publications of the study findings, this research will add to the body of evidence that is considered by organisations and individual care practitioners with regards to the management of drug resistant infections within the NHS.

The findings will be advertised to the general public through the following charities: British Society for Antimicrobial Chemotherapy, Antibiotic Research UK.

Yielded Benefits is not a requirement for new applications.