MORSE (MORtality Study of former professional footballers in England and Wales) Study

Institute of Occupational Medicine (IOM) requires access to NHS England data for the purpose of the following research project:

MORSE - (MORtality Study of former professional footballers in England and Wales)

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

IOM wish to undertake a retrospective study of former professional footballers in England and Wales to assess whether there is an association between the amount of heading undertaken during a professional player’s playing career and risk of death from neurological diseases.

Information gathered for the study will be assembled by IOM from the Barry Hugman’s Footballers’ Website:

http://barryhugmansfootballers.com/, which is at online database of former professional footballers, IOM have supplemented the Barry Hugman database with information from Wikipedia in order to fill in gaps in the playing careers of some of the players. IOM have thus created a new database that IOM are the data controllers for.

The aims of the study are:

To answer the following research questions:

1) Are former professional footballers in England and Wales at increased risk of death from neurological disease compared to the general population (external comparison)

2) How does mortality compare for all causes, respiratory diseases and circulatory diseases between former professional footballers and the general population (external comparison)

3) Is there an exposure-response between cumulative heading of footballs and death from neurodegenerative disorders (internal comparison)

4) Are there other aspects of a former professional player’s career (e.g. position played) that influences mortality from neurodegenerative disorders (internal comparison).

Answers to these questions are expected to to enable a better understanding of whether a career as a professional footballer increases a person’s risk of dying from a neurological disorder and whether this is related to the amount of heading of footballs. To assess whether occupational exposure to playing football was associated with an increased mortality from neurological disorders.

The following NHS England Data will be accessed:

• Civil Registration Mortality – necessary to establish cause and date of death of those who have died in England and Wales. IOM requires data fields to include underlying and associated causes (for the revisions in force at time of death)

• Demographics – necessary to identify informal/formal deaths and reasons for removal/exits from the NHS system.

The level of the Data will be:

• Identifiable – as the IOM require names, date of birth, full date of death, sex, necessary to ensure that there are no transcription errors and that the correct events are allocated to the correct individual. IOM needs to have deaths, including coded underlying and associated causes (for the revisions in force at time of death). In addition, from the Demographic data, the reason for informal death and reason for removal from the NHS will ensure the study has maximum statistical power.

The Data will be minimised as follows:

• Limited to a study cohort identified by IOM assembled by IOM from the Barry Hugman’s Footballers’ Database and augmented from other public sources. It will include English born professional football players, as well as international players who have played any football game in England in one of the top 4 recognised professional divisions (currently described as Premier League, Championship, League One and League Two).

• Cohort consists of approximately between 15,000 - 22,000 professional footballers from 1946 onwards, aged over 40 years, who have played in England and Wales.

IOM is 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)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.

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 The Colt Foundation. The funding is specifically for the MORSE study described.

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

Microsoft Ltd supply IT infrastructure for IOM and are therefore listed as Data Processors.

Microsoft Ltd will store the Data as contracted by IOM.

No Public and Patient Involvement and Engagement group activities have been undertaken during the proposal of the study. However, The Football Association (FA) and Professional Footballers' Association (PFA) are aware of the existence of this study.

IOM will transfer data to NHS England. The data will consist of identifying details Date of Birth, Forename and Surname, 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 mortality and Demographic data set to IOM. The Data will

• contain directly identifying data items including Date of Birth, Surname, Forename and gender.

The Data will not be transferred to any other location.

The data will be stored on Cloud servers at Microsoft Ltd.

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).

The Data will not leave the UK at any time.

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

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

The Data will be combined with publicly available data. Data from NHS England will be linked to each footballer’s playing careers. In addition, estimates of total repeated sub concussive football-related head impacts (mainly headers, but also other impacts to player heads during training and play). The results of the matching will be checked and a pseudonymised data set created that will be used for analysis within IOM.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed.

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

The expected outputs of the processing will be:

• Submissions to peer reviewed journals

• Leaflets designed for the Professional football community (e.g. FA and PFA).

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 datasets from which the information was derived.

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

• Journals

• Social media

• Patient Information leaflets available within the Football community.

• Press/media engagement

Data to be analysed and results published within the next 12 months.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

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

It is hoped that the dissemination of the results of this study will inform policy aimed at protecting the health and well-being of such professional athletes. This may then lead to a review of heading in football which could substantially alter how the game is played both professionally and recreationally.

Not applicable.