Evaluation of ocular and systemic outcomes after treatment of ocular melanoma and other ocular tumours.

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Datasets: + Civil Registrations of Death · − MRIS - Cause of Death Report; − MRIS - Cohort Event Notification Report; − MRIS - Flagging Current Status Report; − MRIS - Members and Postings Report

Objective for processing

Mortality and Cancer data were supplied to the Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust by ONS and subsequently the Health and Social Care Information Centre (which has since become requires access to NHS Digital) England data for the purpose of a research study referred to as Management the following: Service evaluation and audit of Ocular Melanoma ocular and systemic outcomes after treatment of ocular melanoma and other ocular tumours. This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. The following is a summary of the aims of the Service evaluation provided by the Liverpool University Hospitals NHS Foundation Trust. Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required. The data will be used to provide the following services only: The following information provides background information on the purpose of the original study: - Service Evaluation The most common primary intraocular malignancy is uveal melanoma, with an incidence of about 7 per million per year. The chances of dying of metastic disease within ten years increase with large tumour size, eoitheliod cell type, and old age, ranging from 5% - 70% according to the number of risk factors. Survival after conservation of the eye does not seem to be significantly worse than after enucleation (removal of the eye), but further studies are required, particularly with regards to the influence of local tumour recurrence. - Audit Patients from all over Great Britain and overseas are referred to the Ocular Oncology Service, which was established in 1993 and which was designated a supra-regional centre in April 1997. Liverpool University Hospitals NHS Foundation Trust requires death notification data about patients with ocular cancers treated at the Trust, in order to examine local treatment outcomes, prognosis and mortality from the disease or other causes. The data will be used for evaluation of patient outcomes following proton beam radiotherapy (including vision, retention of the eye, and mortality), ruthenium plaque brachytherapy and topical chemotherapy. This will enable a more accurate process of patient counselling and management of patient expectation. The service will then be audited against current international benchmarks regarding mortality outcomes, eye and vision retention and complications. The aims of the study are to evaluate ocular and systemic outcomes after treatment of ocular melanoma and other ocular tumours. The following NHS England data will be accessed: The main ocular outcomes are visual acuity, retention of the eye and complications such as local tumour recurrence, retinal detachment, cataract and optic neuropathy. Civil Registrations of Death: date and cause of death, is necessary to assess patient outcomes of these rare diseases. This will be used to calculate 5-year and 10-year outcomes which are essential for understanding prognosis, directly affecting patient decision making and management plans. The main systemic outcomes are death and cause of death. The level of the data will be: Results will also be evaluated in terms of quality of life/well-being, using standard instruments and a questionnaire. • Identifiable – identifiable data is needed to enable the linkage of the Deaths data with clinical data. These studies should: The data will be minimised as follows: Limited to a cohort of patients, approximately 300 patients per year from 2018. Limited to data between 2018 and latest available for all patients seen at the Liverpool Ocular Oncology Centre. 1. improve definition of the indications and contra-indications for the various forms of treatment for uveal melanoma and other tumours. The Liverpool University Hospitals NHS Trust’s pathology service has a completely anonymised dataset with no identifiable data (such as hospital number, laboratory number or date of birth) by means of a randomly generated pathology ID key. This ID key can only be traced to each original identifiable patient data with great difficulty by means of a complex process of cross referencing the anonymised generated ID data with the clinical database based on tumour characteristics. Both of these datasets are located in different locations, with the clinical dataset within the ocular oncology offices, and the anonymised dataset within the trust pathology department. Both locations are secure. Access to the data is controlled by appropriate supervisors and no individual has access to both databases. 2. identify complications Data may be accessed by staff affiliated with Liverpool University Hospitals NHS Foundation Trust. This includes only substantive positions within the Trust under the direct supervision of one of 3 substantive consultants within the Trust who are responsible for and run the Ocular Oncology service. Staff working with the data held under this Agreement have completed relevant data protection and confidentiality training and are subject to Liverpool University Hospitals NHS Foundation Trust policies on data protection and confidentiality. Staff members would only work on the data for the purposes described in this Data Sharing Agreement. 3. evaluate the benefits of conserving vision in eyes with ocular tumours. Liverpool University Hospitals NHS Foundation Trust is the sponsor and the controller 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)(h) - processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3; Liverpool University Hospitals NHS Foundation Trust believe that these data outcome reports are in the public interest to enable further understanding in the field of this rare disease with a high mortality rate. The need for assessment of patient outcomes is essential in counselling of these patients. These data are used to inform patient oncologists and other professionals involved in the care of uveal melanoma. Although the department is funded by NHS England as a specialised commissioned service, there is no associated funding for this service evaluation/audit purpose. Therefore, this service evaluation and audit is self-funded by Liverpool University Hospitals NHS Foundation Trust. A Public and Patient Involvement and Engagement group has helped refine the purpose of the Service evaluation/Audit. The group strongly supported the collection of the data for the purposes described above. Regular meetings are held with patient support groups such as Ocumel UK to enable such groups to better understand treatment options and outcomes. Liverpool University Hospitals NHS Foundation Trust closely collaborate with the patient support group Ocumel UK and will be in consultation with this group regarding the use of confidential patient information.

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. Liverpool University Hospitals NHS Foundation Trust will transfer data to NHS England. The data will consist of identifying details NHS Number & Date of Birth, for the cohort to be linked with NHS England data. The study data, including data provided by NHS Digital under previous agreements, are currently held by the Royal Liverpool and Broadgreen University Hospitals NHS Trust. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the Royal Liverpool and Broadgreen University Hospitals NHS Trust storage address specified in this Agreement. This cohort will exclude eligible participants who have expressed a project specific opt-out against Liverpool University Hospitals NHS Foundation Trust. For clearness, the data required from NHS England will exclude those who have expressed a project specific opt-out, or a National Data Opt-out. The following provides background on the processing activities undertaken for the original study: NHS England data will provide the relevant records from the Civil Registrations Death to Liverpool University Hospitals NHS Foundation Trust. The data will contain directly identifying data items including, NHS Number, Forename, Surname, Date of Birth and the Date and Cause of death which are required to link the data at record level with data already held by the Liverpool University Hospitals NHS Foundation Trust. Identifiable data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at the Royal Liverpool and Broadgreen University Hospitals NHS Trust of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in September 2018. The data will not be transferred to any other location. The data will be stored on servers at Liverpool University Hospitals NHS Foundation Trust. The data will be accessed onsite at the premises of Liverpool University Hospitals NHS Foundation Trust only. Personnel are prohibited from downloading or copying data to local devices. All personnel accessing the data have been appropriately trained in data protection and confidentiality. Civil Registration Deaths data is to be linked to clinical data obtained within the service. The data will be linked at person record level with datasets obtained from Liverpool University Hospitals NHS Foundation Trust. These are clinical data in the Trust’s electronic patient record. The NHS England Mortality data will be correlated with clinical data (such as the size and location of the tumour) The details will then be stored in a separate database to create a completely anonymised dataset used for analysis. Once this has been transferred the date of death and any other identifiers provided by NHS England are no longer required and will be destroyed. All analyses will use the anonymised dataset. As mentioned above, anonymisation occurs by means of a randomly generated pathology ID key. This ID key can only be traced to each original identifiable patient data with great difficulty by means of a complex process of cross referencing the anonymised generated ID data with the clinical database based on tumour characteristics. Both of these datasets are located in different locations, with the clinical dataset within the ocular oncology offices, and the anonymised dataset within the trust pathology department. Although both areas are secure with limited supervisors with access no individual has access to both databases. Subject to approval from one of the Liverpool University Hospitals NHS Foundation Trust consultants involved in this study, pseudonymised extracts may be linked to Pathology data (not NHS England data) which is held and stored within the pathology department at Liverpool University Hospitals NHS Foundation Trust. On request (and approval of the supervisor) the pathology data is extracted by the pathology Data Manager and utilised only on hospital secure computers within the Trust. By means of the pseudonymised pathology ID key, the data can be linked. No data flows to the pathology team with exception of the required pathology IDs.

Expected output

No new outputs will be produced under this Data Sharing Agreement. The expected outputs of the processing will be: In any future application, the applicant will be required to provide details of the outputs that were produced and disseminated by the study as well as details of any future outputs planned. • A service evaluation report of findings in parallel to new revised uveal melanoma guidelines will be produced to NHS England commissioners on an annual basis to enable improvements in patient care. • Submissions to peer reviewed journals, approximately 3-5 per year. • Presentations at Ocular Oncology conferences. 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 • Workshops • Webinars open to teaching events held locally/national and international teaching. • Social media – Royal Liverpool Hospital twitter account published papers. • Public reports • Posters displayed at conferences. • Patient Information leaflets • Public promotion of the outcomes provided on patient forums. • Conferences/teaching events held at various locations. Outcome audits of patient treatments and mortality would be expected to be presented to NHS England commissioners on an annual basis. Service evaluation reports in parallel to new revised uveal melanoma guidelines will be produced to enable improvements in patient care on an ongoing basis. Papers will be published on outcome data.

Expected measurable benefits

In any future application, the applicant will be required to provide details of the expected benefits resulting from the study. The service evaluation is hoped to: • Improve definition of the indications and contra-indications for the various forms of treatment for uveal melanoma and other ocular tumours. • Identify complications such as loss of vision. • Evaluate the benefits of conserving vision in eyes with ocular tumours. The findings of this Service evaluation/Audit are expected to contribute to evidence-based decision-making for policymakers, 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 disease. 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. • 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. It is hoped that through publication of findings in appropriate media, the findings of these Service evaluation/Audits 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. To summarise, it is hoped this data will provide: 1. Further development of UK melanoma and European Melanoma guidelines to improve and streamline quality of patient care. 2. Evaluation of current screening practices for metastatic surveillance.

Benefits reported

Stated in the previous version and removed here.

In any future application, the applicant will be required to provide details of the actual benefits achieved as a result of the study.