MIDAS (MIDAS-GP and MIDAS-Population) project

Keele University requires access to NHS England data for the purpose of the following research project:

MIDAS (MIDAS-GP and MIDAS-Population) project

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

Painful musculoskeletal conditions like back pain and osteoarthritis cause more disability in the general population than any other health conditions. Poorer communities and individuals appear to be hardest hit. To have a suitably ‘joined up’ response to this challenge, accurate and meaningful joined up information on musculoskeletal health, risk, and care in local populations in needed. This is what the MIDAS project aims to address.

The MIDAS programme of research seeks to develop and evaluate a place-based system for population musculoskeletal health intelligence across North Staffordshire and Stoke-on-Trent.

Under the wider MIDAS project, two studies require access to NHS England data under this Data Sharing Agreement:

(1) "Real world" pain outcomes and experiences of care (MIDAS-GP)

(2) Multi-level Integrated Data for Musculoskeletal Health Intelligence and Actions: Population Survey (MIDAS-Population)

MIDAS-GP Objectives:

> To estimate the magnitude and direction of differences between potentially ‘disadvantaged’ and ‘advantaged’ groups of patients in their reported musculoskeletal health outcomes up to 6 months after consultation [patient reported outcomes/experiences sub-cohort]

> To estimate the magnitude of between-practice variation in processes of care for adults consulting with a MSK pain condition [EHR-only processes of care]

MIDAS-Population Objectives:

> To describe musculoskeletal health and inequalities in the adult population

> To describe and compare the biopsychosocial context of adults with musculoskeletal health problems

> To relate local estimates of musculoskeletal health need with use of healthcare services

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC), HES Accident & Emergency (A&E), HES Outpatients (OP) and Emergency Care Data Set (ECDS) – necessary to meet the objectives detailed above.

The following sensitive field has been requested: registered GP. This sensitive field is required to link to the GP practices who took part in the study.

The level of the Data will be:

> Identifiable

Although the Data requested contains pseudonymised data fields only, Keele University hold and have access to the identifiers. Therefore, though no effort will be made to identify participants, the identifiability has been set to identifiable as the technical means to re-identify exists.

The Data will be minimised as follows:

> Limited to a study cohort identified by Keele University – comprised of 2 consented cohorts. Cohort A: Adults aged 18+ years who were registered with a participating North Staffordshire or Stoke-on-Trent general practice during the study period for a common musculoskeletal pain condition (MIDAS-GP cohort; cohort size approximately: 2,009). Cohort B: Adults aged 35 years and over who were registered with a participating North Staffordshire or Stoke-on-Trent general practice during the study period (MIDAS-Population cohort; cohort size approximately: 2,565).

Keele University 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 analyses of these data will be used to identify unwarranted variation and disparities in care for adults living with a musculoskeletal pain condition. These conditions are the leading causes of long-term pain and disability in the general population and associated with substantial personal, NHS, and societal costs. Keele University's Patient Advisory Group have stressed the importance to patients of getter and using better ‘real world’ information to improve the quality of care for people living with these conditions.

The funding is provided by the Nuffield Foundation. The funding is specifically for the project described.

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

Data will be accessed by:

· Substantive employees of Keele University

· Students enrolled with Keele University. The individual has completed mandatory data protection and confidentiality training and is subject to Keele University’s policies on data protection and confidentiality. The individual accessing the data will do so under the supervision of a substantive employee of Keele University. Keele University would be responsible and liable for any work carried out by the individual. The PhD student would only work on the data for the purposes described in this Data Sharing Agreement (DSA).

· Individuals holding an honorary contract with Keele University (currently only one individual) under the supervision of a substantive employee of Keele University for the purposes described in this DSA only. Keele University must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

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

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

o 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;

o 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.

Keele University have a MIDAS Patient Advisory Group (PAG) who have

already been involved in designing this study. The Group have:

• stressed the importance of looking seriously at inequalities in health and care,

• suggested ways of raising awareness, maintaining interest in the study, and making it easier for a wide range of people to take part,

• looked carefully at the questionnaires and suggested ways of making it more relevant and easier to complete,

• highlighted ways to improve response and overcome barriers linked to low survey participation

The study team will continue to work with the PAG to monitor how the study is going, what the findings mean, and how best to share them with participants, the public, and other groups, to maximise the chances of this research making a real difference. In addition, Keele University have access to a Race Equality Ambassador who can advise on the NIHR Race Equality Framework for Public Involvement in Research.

Keele University will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth 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 and ECDS datasets to Keele University. 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 Keele University.

The Data will be accessed onsite at the premises of Keele University and 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.

Data will be accessed by an individual with an honorary contract with Keele University. The individual will act as an agent of Keele University at all times under supervision from employees of Keele University. Aside from this individual, access is restricted to employees of Keele University 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 MIDAS-GP Study questionnaire answers obtained from participants and GP data obtained from participating general practices (30 located in North Staffordshire & Stoke-on-Trent) for MIDAS-GP and MIDAS-POP participants who provided individual informed consent for this.

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 identifiers will be destroyed following data receipt.

Researchers from Keele University will process the Data for the purposes described above.

The expected outputs of the processing will be:

> Submissions to peer reviewed journals: 2-3 submissions are expected

> Creation of code lists, programming code (e.g. weighting)

> Databases: survey data and health data will be collated into databases which will be made available to researchers internal to Keele University. This data will be anonymised with small numbers supressed.

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

> Dashboards: aggregate level estimates derived from anonymised linked data may be included in pilot power BI dashboards published on Keele University's webpages and shared with NHS providers and other relevant stakeholders to understand their MSK health intelligence information needs and preferences

> Plain Language summaries will be published on Keele University webpages.

Outputs are expected to be produced throughout 2026.

The findings of this research study are expected to underpin the development and implementation of a place-based system of MSK health intelligence in the population of North Staffordshire and Stoke on Trent that provides, timely, sustainable, trustworthy evidence for policymakers, practitioners and the public. The findings are also expected to describe the frequency, distribution, inequalities and variation in MSK healthcare and outcomes and the determinants of those inequalities.

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 obesity and diabetes.

> 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).

This is an observational study, therefore, no specific direct benefits to participants are expected. However, this work is expected to raise awareness of musculoskeletal health conditions and current patterns of healthcare use and care for these. Findings that identify unwarranted variation and disparities that help healthcare professionals, service managers, and commissioners may benefit patients in the future through the provision of more effective and efficient care but also highlighting the important of determinants with the formal healthcare system.

There are two main mechanisms proposed:

(1) raising public awareness and understanding of MSK pain conditions and quality of care;

(2) engaging with service managers and commissioners to critically review the commissioning and delivery of healthcare services and wider health promotion and prevention for MSK pain conditions

Keele Univesity have been working closely with their local Integrated Commissioning Board and service managers to ensure that the research findings will address important evidence gaps and health intelligence needs for service planning and delivery. Keele University's communication plan has identified multiple channels to reach key audiences including the use of social media, press releases, and webpages to reach public audiences. Their work is funded by two prominent national charities - Nuffield Foundation and Versus Arthritis - with whom they are working to disseminate and amplify key findings from this research.

Yielded Benefits is not a requirement for new applications.