An evaluation of the clinical efficacy and risk profile of routine spinal operations performed in the National Health Service

Queen Mary University of London (QMUL) requires access to NHS England data for the purpose of the following research project:

‘An evaluation of the clinical efficacy and risk profile of routine spinal operations performed in the National Health Service’

The following is a summary of the aims of the research project:

The study aims to validate the British Spine Registry (BSR). The BSR was established in 2012 by the British Association of Spinal Surgeons (BASS) to monitor the results of spinal surgery and improve operative outcomes. The Registry collects routine data on spinal procedures performed in the UK and patient-reported outcome data. Given that the BSR is a relatively new registry, it has not yet been validated. The project team want to link the BSR with the Data under this Agreement to validate the Registry’s accuracy.

The project team will then use the linked dataset to achieve the following aims:

1. To assess the clinical outcomes of common spinal surgery procedures for low back pain

2. To investigate the effect of patient and surgical factors on clinical outcomes

3. To compare the efficacy of different spinal surgical procedures in treating low back pain

The following NHS England Data will be accessed:

- Hospital Episode Statistics Admitted Patient Care – necessary to understand reoperations, readmissions, surgical/medical complications, length of stay and cost of hospital admission which are key to achieving the study’s aims

- Civil Registrations of Death - necessary to understand mortality within the study population which is key to achieving the study’s aims

The level of the Data will Pseudonymised.

The Data will be minimised as follows:

- Limited to individuals contained within the British Spinal Registry, a cohort will be provided by Amplitude Clinical Outcomes who manage the BSR on behalf of BASS. (Approx ~100,000 individuals)

- Historic hospital episodes will be collected up to 5 years prior to each individual's first spinal procedure (For the BSR cohort). The earliest records would be 2010/11.

- In addition to the above, a cohort will be identified by NHS England (Control cohort) that includes individuals who have received spinal procedures between 1st April 2010 to 1st January 2023 as defined by specified OPCS codes for routine spinal surgical procedures.

- For individuals in this control cohort that meet the above criteria data will be limited to records that fall between 2010/11 to latest available at time of dissemination.

QMUL 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)(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.

The funding is provided as part of a National Institute for Health and Care Research (NIHR) Academic Clinical Fellowship. In addition, the applicant holds the Barts ACF charity award to fund this specific project. The funders will have no ability to suppress or otherwise limit the publication of findings.

The research team at Barts Bone Joint Health has created a patient and public advisory group database for musculoskeletal research. The group were recruited though local organisations such as social action for health, Barts Health NHS trust and social media. The majority of people in the database are local (east London) and represent a mixed demographic.

The patient and public advisory group were provided with a summary of this research and were asked if they would be interested in assisting the development of research questions, design, and results presentation. During the workshop the study team asked patients what the most important research questions are for back pain and spine surgery, outcomes they felt should be assessed, what defines success/failure for this project and how they felt about the use of large routinely collected datasets in this context.

The advisory group felt that it was the study team's responsibility to use routinely collected datasets to help improve quality of care for patients and that this was a moral obligation.

Amplitude Clinical Outcomes, on behalf of BASS, 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 aforementioned datasets to QMUL. 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 QMUL.

The Data will be accessed onsite at the premises of QMUL only.

The Data will not leave England at any time.

Access is restricted to employees of QMUL 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 linked at the person record level (at QMUL) with BSR data (registry ID and pseudonymised data) obtained from BASS

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

Analysts from QMUL will process the Data for the purposes described above.

The expected outputs of the processing may include:

- Submissions to peer-reviewed journals. The study will be targeting journals such at the Lancet, The British Medica Journal and the Journal of Bone and Joint Surgery.

- Presentations at the American Academy of Orthopaedic Surgeons, the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress, and the British Orthopaedic Associations Meeting

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- the team have a dedicated X (formerly Twitter) account

- Press/media engagement

The dissemination of outputs should be expected within 6 months of receiving data the requested data, outputs can be expected on an on-going basis for the current planned length of the project (5 years).

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 research aims to help guide clinicians and patients on the risks and benefits of each spinal procedure. Through studying different patient subgroups of the population, this will give great insight into patient factors which influence doing better or worse with surgery and ultimately help deliver more patient specific care.

An assessment of surgical factors and how they affect outcomes has the potential to help deliver better surgical care.

An exploration of the cost effectiveness of different procedures may help guide healthcare providers into which treatment is the most clinically effective and ultimately develop new guidelines.

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 patient.

The project team intend to use the study’s X (formerly Twitter) account and the University’s webpage to advertise the findings to a wider audience as possible. In addition, the BASS will disseminate key outputs from the study on their webpages.

Yielded Benefits is not a requirement for new applications.