Motor Neuron Disease Register

King’s College London and University of Oxford require access to NHS England data for the purpose of the following research and non-research purposes:

The MND Register.

Motor Neuron Disease (MND) is a neurodegenerative disease that involves loss of function or death of the cells which relay messages between the brain and muscles (known as motor neurons). The pathology causes progressive muscle wasting and paralysis, and death is often by respiratory failure. Apart from a small genetic subset of people, there is currently no cure for MND.

Currently, the project receives health record data from sites across England, Wales, and Northern Ireland that treat people with MND. The data include a demographic subset and a clinical subset with details of the MND diagnosis and key features. It is necessary to collect data directly from treating services to ensure that the diagnosis has been confirmed by a neurologist and to request clinical details related to disease progression that are not collected in routine healthcare datasets. However, due to the burden on people collecting the data at individual sites the study team are seeking to supplement the clinical data with routinely collected administrative healthcare data in order to better address the research questions.

The following is a summary of the aims of the research project provided by King’s College London and University of Oxford: (covered by s251 21/CAG/0009)

The MND Register is a population register that aims to collect information about all people with a diagnosis of MND in England. The team aim to use this information to accurately estimate incidence and prevalence of MND in those areas. The team also aim to investigate epidemiological research questions including geographical spread of disease including clustering, natural history of disease, factors related to disease progression, hospitalisation need, and access to disease modifying interventions. This application is for England only.

The following is a summary of the aims of the non-research project provided by King’s College London and University of Oxford (covered by s251 21/CAG/0028)

To improve care planning, looking at regional differences, and enabling the applicants to provide answers associated with the NICE MND Audit. Development of a mathematical model of MND. Such models can inform future studies, drug discovery and knowledge of

pathogenesis of the disease.

The following NHS England Data will be accessed:

• Hospital Episode Statistics (HES)

- Admitted Patient Care (APC) – necessary because people with MND may be offered interventions such as gastrostomy, tracheotomy, and non-invasive ventilation.

- Outpatients – necessary because people with MND are seen regularly at outpatient appointments.

- Accident & Emergency (A&E) – necessary because people with MND are admitted to A&E for respiratory arrest.

• Civil Registration Mortality – necessary because disease duration is commonly used as an endpoint for many research studies as MND currently does not have a cure. It is important to have up-to-date mortality data for the cohort to support statistical analysis.

There are two parts to this request

Identifiable:

Necessary because the data needs to be linked to the clinical dataset collected by the MND Register to allow analysis of individual records.

Aggregated:

Aggregated HES APC data will be accessed on people with MND (identified by ICD10 code G12.2) who are not present in the MND cohort to estimate case ascertainment. This will be broken down by Lower layer Super Output Areas (LSOAs) in order to estimate case ascertainment against the catchment areas. As this project is a population register aiming to count every person with MND in England, case ascertainment statistics are important in assessing the success of the register and the generalisability of the statistics. The purpose of the aggregated data is to ascertain the coverage that the current MND Register Cohort provides and the study team are not seeking to necessarily capture the data of people who have opted out of the MND register and not requesting patient level information relating to these individuals.

The Data will be minimised as follows

• Limited to a study cohort of 9605 patients identified by King’s College London and University of Oxford – the cohort comprises people with a confirmed diagnosis of MND over the age of 16 diagnosed between 01/04/2020 and 01/04/2024, identified by the case load of services treating people with MND.

• Limited to data between 2020/21 and 2023/24.

Aggregated HES APC data:

Limited to patients identified in HES APC through the following inclusion and exclusion criteria:

• Inclusion criteria: any patient diagnosed with MND between 01/04/2015 and 31/03/2024 who was aged over 16 at diagnosis and who have records of MND diagnosis or treatment based on ICD-10 diagnosis code G12.2.

• Exclusion criteria: any patient who is included in the cohort submitted to NHS England for linkage.

King’s College London as the research sponsor, and University of Oxford as the main collaborator, are joint controllers as the organisations 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 personal 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 will be used for research into MND.

The funding is provided by the MND Association. The funding is specifically for the project described. Funding is in place until 30/06/2025.

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

The following organisations are involved in the above project but will not access the data:

• Steering committee: Sheffield University, Edinburgh University, and MND Association

• Data access committee: MND Association, Cambridge University, and South Wales MND Care Network

Patients from the Sheffield MND Research Advisory Group, the MND LOROS Patient Support Group, and the South London MNDA Patient Focus Group were consulted. The feedback received was very positive with patients strongly supporting the proposal. Copies of the patient-facing documents were distributed to the group for review, and the group explained that they felt that some of the terminology used in these documents was complicated to understand. After further discussions with the group, the documents were updated to include terminology that was easier to understand for patients and carers.

King’s College London will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender, 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 APC, HES Outpatients, HES A&E, and Civil Registration Mortality datasets to King’s College London. 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

The data will not be transferred to any other location.

The data will be stored on servers at King’s College London hosted on the OpenStack private cloud.

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.

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 at any time.

Access is restricted to substantive employees and enrolled students King’s College London, University of Oxford, and London School of Hygiene and Tropical Medicine who have authorisation from the Principal Investigators.

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

Analysts/researchers from King’s College London, University of Oxford, and London School of Hygiene and Tropical Medicine will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• Annual reports of findings to the MND Association.

• Submissions to peer reviewed journals – the number and frequency of publications will be determined following receipt of the data.

• Annual presentations at appropriate national and international conferences (such as the ENCALS meeting in Turin in 2025, and the International Symposium on ALS/MND in San Diego).

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

• Social media

• Public reports

• Briefing documents provided to policy organisations such as National Institute for Health and Care Excellence

• Posters displayed at appropriate conferences

• Patient Information leaflets available at MND services

• Press/media engagement

• Public promotion of the research by the MND Association

• Participant newsletters

A general report and manuscripts are expected to be produced a year on receipt of the data.

The findings of this research study are expected to contribute to evidence-based decision-making for local decision-makers to inform best practice to improve the care and treatment of health care users relevant to motor neuron disease. The research database will be a resource for people studying motor neuron disease to help drive research insights.

The use of the data could:

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

• 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 people with motor neuron disease.

• 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.

• support knowledge creation or exploratory research through modelling projects using the data (and the innovations and developments that might result from that exploratory work).

• development of a mathematical model of MND. Such models can inform future studies, drug discovery and knowledge of pathogenesis of the disease which will benefit patients with MND (this sits within non research).

The research is hoped to contribute towards knowledge of the causes of MND due to the linkage to different familial, demographic, environmental, and lifestyle risk factors with the development of MND and disease progression.

The register has the potential to benefit patient treatment because results are anticipated to inform clinical trial design making power scores more accurate. This means that physicians could make more informed decisions on how patients are treated based on their presenting symptoms. The MND register is hoped to inform care planning because it will provide counts of how many people in an area have the disease, what their prognostic characteristics are, and what care different groups require.

It is hoped that through publication of the findings of this research will add to the body of evidence that is considered by the organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

The research will be promoted on the MND social media accounts to optimise the potential public benefits from the use of the data. The MND Association has an active research promotion team which will be utilised to publish the research findings. The sites that submit data will be contacted to enable the research findings to be used locally to inform patients about their services.

Yielded Benefits is not a requirement for new applications.