OPAL - The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study

The University of Oxford and the University of Exeter requires access to NHS England data for the purpose of the following research project: OPAL - The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study.

The following is a summary of the aims of the research study provided by the University of Oxford:

a. Describe the prevalence, severity, course, and prognosis of a range of musculoskeletal problems in older people.

b. Evaluate the impact of back pain on important health outcomes for older people (quality of life, mobility, falls and fractures)

c. Study a range of factors hypothesised to moderate and mediate the effects of back and other musculoskeletal pain for example, co-morbidities.

d. Perform an economic evaluation of cost of NHS resources used by participants mapped to the health conditions that were self-reported at baseline and in subsequent follow-up questionnaires.

The OPAL Cohort Study is being conducted under a programme of works funded by the National Institute for Health Research Programme Grants for Applied Research funding scheme. The OPAL Cohort Study are projects 2, 3 & 6 of the programme of works detailed below:

1. To refine a physiotherapy intervention for Neurogenic Claudication (NC) (Project 1). NC is intermittent leg pain from impingement of the nerves emanating from the spinal cord

2. To complete a feasibility study for a prognostic study and clinical trial of the NC intervention in the UK NHS (Project 2)

3. To develop a tool that is expected to help clinicians and older people recognise when and what types of Low Back Pain (LBP) are important targets for treatment for older people. The outcomes will be mobility disability (primary model), disability, frailty and falls (Project 3)

4. To undertake a definitive randomised controlled trial demonstrating that access and participation in a physiotherapy intervention for NC can improve important outcomes including pain, disability, mobility, frailty and falls (Project 4)

5. Explore whether MRI scans and other factors can help determine who may and may not respond to this treatment (Project 5).

6. To integrate the findings of the trial and the prognostic tool into a package of treatments that can be used in primary care and other settings. This is intended to include exploring GP's attitudes and beliefs to inform implementation and future research (Project 6).

The following NHS England data will be accessed:

> Hospital Episode Statistics;

- Admitted Patient Care

- Accident & Emergency

- Critical Care

- Outpatients

The use of Hospital Episode Statistics data is expected to allow an economic evaluation of the cost of NHS resources used by participants mapped to the health conditions that were self-reported at baseline and in subsequent follow-up questionnaires. Data is requested from the four HES datasets to ensure the study team capture a complete picture of NHS usage by study participants.

> Emergency Care Data Set (ECDS) – necessary because this dataset replaced HES Accident & Emergency dataset from 2019 onwards.

> Civil Registration of Death (Secondary Care Cut) – Necessary to know the time frame that participants may have been accessing health care. In addition, deaths data will be used to minimise any distress caused to surviving family members if further questionnaires regarding the deceased participant were to be sent.

The level of the data will be:

> Pseudonymised

The data will be minimised as follows:

• Limited to a study cohort identified by the University of Oxford – 5,409 community dwelling adults aged 65 years and over, invited from 35 primary care practices across England within West Yorkshire, Merseyside, West Midlands, Gloucestershire, Dorset, Wiltshire, London, Oxfordshire and Cambridgeshire.

• Limited to data between October 2016 and October 2023. For each individual patient, data will only be provided from the date they consented to join the trial until 5-years after the date of consent.

The University of Exeter as the research sponsor, and the 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 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 National Institute for Health Research. The funding is not specifically limited to the study described. This funding is in place until 31st January 2024. Further funding from the NIHR Oxford and Thames Valley Applied Research Collaboration is place to specifically support this study until 30th September 2024.

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

Microsoft Limited provides IT hosting services to the University of Exeter and will store the Data as contracted by the University of Exeter.

There are no other organisations involved in an advisory capacity or as part of a steering committee.

The data will be accessed by substantive employees of the University of Exeter.

The University of Oxford worked with a Patient and Public Involvement and Engagement Group of people of 65 years of age throughout the study to refine the purpose of the research. The group were very supportive of the research and strongly supported the collection of the data the purposes described above. The study team met with the PPI group and discussed the relevance of different outcomes related to this programme of work including the importance of health care use as an outcome. In addition, a PPI Representative was part of the study team management group who were responsible for delivering this research and helped develop the protocol in which health research use is included as one of the key outcomes of interest of the OPAL study.

The University of Oxford will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Surname, Forename, Date of Birth, Postcode, Gender and Consent Date), for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES Outpatients, HES Critical Care, HES Admitted Patient Care, HES Accident & Emergency, Emergency Care, and Civil registrations of death datasets to the University of Exeter. 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 identifiable 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 the University of Exeter only.

The University of Exeter stores Data on the Cloud provided by Microsoft Limited.

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

Access is restricted to individuals within The University of Exeter who have authorisation from the Principal Investigator. All such individuals are substantive employees of the University of Exeter.

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

The data will be linked with questionnaire data obtained from OPAL cohort study using the study ID.

The identifying details from the questionnaire data 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.

Statisticians and data analysts from the University of Exeter will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer reviewed journals such as The Journals of Gerontology and Age and Ageing. The study team expect to submit papers to journals from 2024.

• Presentations at appropriate conferences such as The British Society of Gerontology Annual Conference and The Society for Academic Primary Care Annual Conference.

• Publication of a plain English summary of study results for the general public on the study website (University of Oxford’s website https://opal.octru.ox.ac.uk/welcome )

• Outputs will inform the development of training materials for health professionals working with older people along with findings from the broader programme of research including the prognostic tool developed to identify when older people are at risk of mobility decline. This training would be provided free of change.

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

• Website publications - The website will host published articles, conference papers, videos and tutorials for NHS colleagues, health care planners, commissioners, and patients. It is expected that this will include e-learning tutorial videos demonstrating the prognostic tool and providing a prognostic calculator for both the public and healthcare professionals. The website is expected to include oral and video clips of older people describing their experiences of living with lower back pain (LBP).

• Social media

• Posters displayed at relevant conferences.

The University of Oxford expects to produce and disseminate outputs from 2024 onwards.

The findings of this research study are expected to contribute to evidence-based decision-making for clients; 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:

• 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 the need for, or effectiveness of, preventative health and care measures for patients over 65 suffering with low back pain.

• 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 (and the innovations and developments that might result from that exploratory work).

The use of a prognostic tool to help General Practitioners understand when low back pain should be considered a substantial threat to the well-being of older people may benefit patients by relieving or preventing loss of mobility, disability, and potentially reduce risk of frailty and falls.

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

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, General Practitioners would need to adopt and utilise the prognostic tool to maximise benefits to patients.

Yielded Benefits is not a requirement for new applications.