Risk Of Aneurysm Rupture Study (ROAR)
University Hospital Southampton NHS Foundation Trust · NHS Trust
In term In term in the September 2026 edition: the latest version runs to 2 December 2028.
- Reference
- DARS-NIC-334745-L4J6P
- Current version
- v3.3
- Term of current version
- 3 December 2025 to 2 December 2028
- Start date
- 12 December 2022
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 124
Why the data was released
Objective for processing
University Hospitals Southampton NHS Foundation Trust (UHS) requires access to NHS England data for the purpose of the following research project:
Risk Of Aneurysm Rupture Study (ROAR)
The following is a summary of the aims of the research project provided by the UHS:
“Unruptured intracranial aneurysms (a bulge in a blood vessel caused by a weakness in the blood vessel wall) are a common condition (3% of the population) which have life threatening implications for the patient if they rupture. Patients who suffer a ruptured brain aneurysm are frequently left dead or severely disabled. Decision making around the prophylactic treatment (a prophylactic is a medication, or a treatment designed and used to prevent a disease from occurring) of unruptured brain aneurysms is part of routine practice in neurosurgery and the results from this study will help predict a patient's risk of rupture and thus guide the clinical management of these patients towards the lowest risk option possible.
The aim of this study is to describe the natural history of unruptured intracranial aneurysms (UIA) in England. The condition is of great clinical importance because of the high prevalence of UIA with diagnoses continually increasing due to the widespread availability of imaging and increasing age of the population. Despite this there are great uncertainties as to how to manage patients with UIA. The management is fundamentally based on the balance of risk between treatment and the natural history of the UIA. However, as described above, our understanding of UIA natural history is flawed and thus currently patients are potentially being subjected to the risk of over- or under-treatment. The possible negative outcomes from either unnecessary prophylactic aneurysm treatment or from subarachnoid haemorrhage (SAH), include stroke, long term disability and death, and thus it is crucial that patients are provided with most accurate information possible for their treatment decisions.”
This amendment now seeks the inclusion of the Maternity Services Data Set to help answer the longstanding, and unanswered, clinical question - what advice to give to women with unruptured aneurysms who want to get pregnant? Patients want to know what is the risk of the aneurysm rupturing during pregnancy, should their aneurysm be treated before they get pregnant and what are the rupture risks during delivery. The implications of rupture during pregnancy, in addition to the neurological injury to the patient from subarachnoid haemorrhage, include the potential for harm to the foetus from ionising radiation used to investigate and treat ruptured aneurysms. Blood pressure changes during gestation and during delivery may increase the risk of aneurysm rupture and many women are advised, or opt themselves, for Caesarean sections to mitigate this risk however there is currently no evidence to actually support this. Within the ROAR cohort of patients with unruptured aneurysms there will be a subset of women who were pregnant after their aneurysm was diagnosed. The purpose of the amendment is to evaluate the role of pregnancy as a risk factor for aneurysm rupture by identifying all episodes of pregnancy for women in the ROAR cohort, how many women had a ruptured aneurysm during pregnancy and what are the risk factors associated with rupture during delivery.
The following is a summary of the aims of the research project provided by UHS:
Primary Aims:
Aim 1 - To validate the PHASES score in a UK population.
Aim 2 - To develop a new prediction model including all described predictors of risk.
Aim 3 - To report long-term risk of aneurysm rupture.
Secondary Aims:
Aim 4 – To develop risk models of aneurysm growth.
Aim 5 – To evaluate the efficacy of aneurysm screening regimens.
Aim 6 – To develop and evaluate new radiological predictors of aneurysm growth and rupture.
Aim 7 – To develop a prognostic rupture model for patients with ADPKD.
Aim 8 – To develop risk models for aneurysm rupture during pregnancy and delivery.
The following NHS England Data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care – necessary to provide information on hospital admissions for aneurysm rupture events or elective aneurysm treatment. Rupture is the primary outcome and elective treatment is a censoring event. Aneurysm rupture produces severe symptoms and thus nearly all ruptures who don't die immediately will get admitted to hospital. All potential ruptures identified will be validated to confirm true ruptures from miscoding.
• Civil Registration of Death – necessary for two purposes. The date of death for those patients who die from causes other than aneurysm rupture will be a censoring event when a patient’s aneurysm rupture risk stops. The cause of death is important to identify patients who had an aneurysm rupture and died without attending hospital and thus will not be included in APC data.
• Patient Demographic Service - Required in order to be able to check successful linkage of patients data, to ensure that where data is missing, the reason for that missing data is known. Without the amendment, the aneurysm rupture rates produced by this study will be unreliable as they will contain an unmeasured degree of inaccuracy. Whilst this inaccuracy is likely to only be a few percent based on pilot data it is important that data be as accurate as possible.
• Maternity Services Data Set - a secondary outcome of the study is to measure the risk of pregnancy and different delivery methods on aneurysm rupture. In order to determine the rupture rate during pregnancy it is necessary to know details of all pregnancies that occurred in this cohort.
• Diagnostic Imaging Dataset (DID) - Imaging will be subjected to advanced image analysis (e.g. Computational Fluid Dynamics (CFD) and Convolutional Neural Networks (CNN)) to derive new predictors of rupture to be tested in the main ROAR prediction models. In order to aid in the identification of radiological investigations for these patients, which could have been performed across the UK, the cohort will be linked to the Diagnostic Imaging Dataset by NHS England for data on the scans these patient have received.
The level of the Data will be identifiable because UHS holds the identifying details of the cohort. Identifiable data include date/cause of death (where applicable) which is needed for censoring the length of follow-up and serves as the date of aneurysm rupture for out of hospital deaths. The date of death will be anonymised into a duration of follow-up within 60 days of data receipt in accordance with the CAG support. Additionally, NHSE will return from the Demographics data identifiers pertaining to date of birth, names and postcode for validation purposes where they will be checked against the data held by the recipient to confirm the correct patient linkage. All identifiers, both those initially held by UHS and those received from NHSE will be deleted within 60 days of data receipt (with the exception of the CAG extension required to receive scans through PACS).
The data will be minimised as follows:
- Limited to data for a study cohort identified by neurosurgery units and renal units in the UK and then sent to UHS – Limited to adults aged 18 years or older with an Intracranial intradural unruptured aneurysm confirmed on angiogram (a type of X-ray used to check blood vessels), and a diagnosis of UIA between January 2006 and December 2020.
- Limited to data between 2006 and latest availability (expected 2024).
- Limited to conditions relevant to the study identified by specific ICD or OPCS codes.
- Limited to pseudonymised data only when accessed for analysis purposes.
The reason the cohort is limited to 'over 18's' is that cerebral aneurysms are seen with advancing age, the average age of diagnosis is in the 50s. Aneurysms are rare in children and when they do occur they are likely due to a different underlying mechanism and so their natural history is expected to be different. Including patients <18 years old would interfere with the accuracy of the results.
UHS is the research sponsor and 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 it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding will be provided by National Institute for Health and Care Research (NIHR). Funding is in place until 31/08/2024. Previous iterations of this agreement also had an additional funding source of Smile4Wessex. Funding to continue the work described will be sought on an ongoing basis.
University of Oxford are not accessing the data but acting in an advisory capacity to the study. No NHS England data will be shared with the University of Oxford.
A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the data for the purposes described above.
The PPIE group is a forum for patients and carers with SAH and UIA established in 2001 and available to over 2000 patients during that time. It runs bi-monthly meetings with typically 30 to 50 participants and has been on social media since 2016 (187 current members). Recurrently the main themes at Q&A are around anxiety, and more specifically “what is the risk I will have a haemorrhage”. These observations of patient concerns were mirrored closely in an analysis of online discussion groups of patients with UIA5.
A workgroup to discuss UIA research was organised (advertised via the support group page on social media) where it was confirmed that better decision making on aneurysm treatment is the main concern for patients, but patients do not want their management to be randomised and therefore a Randomised Controlled Trial (RCT) is unlikely to succeed. Consequently, a better understanding of the natural history of UIA was deemed the top priority and that long term, ideally lifetime risks, are what is relevant to patients. On the basis of this, a observational study of the natural history was designed rather than an RCT.
The Trial Management Group (TMG) includes a PPIE lead who is a patient representative with personal experience of both unruptured and ruptured aneurysms. They attend all TMG meetings. The team are also holding PPI meetings every 6 months which will be open to stakeholders from across the UK. These meetings will help guide secondary analysis and the methods of disseminating the results so that they are tailored to the lay audience’s needs.
Processing activities
Neurosurgery units and renal units in the UK will send the study cohort to UHS. UHS will then transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, full name, Date of Birth, Postcode, gender, and a unique person ID) for the cohort to be linked with NHS England data.
NHS England will then provide the relevant records from the Hospital Episode Statistics Admitted Patient Care (HES APC), Civil Registrations of Death, Demographics, Diagnostic Imaging Dataset and Maternity Services datasets to UHS.
The data 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 contain identifying data.
Date of death will be converted into a length of follow-up duration in days within 60 days of data receipt by UHS. Forename, surname, date of birth and postcode from the demographic data will be checked against the data held by the recipient to confirm the correct patient linkage, these data points will be deleted within 60 days of data receipt.
Following processing of the NHS England data, the study team will contact the specific neurosurgery unit and use the study ID for the unit to review any radiology imaging and/or discharge summaries to confirm that the rupture event identified in HES APC matches and there are no errors in their coding. This process will only use the date of potential rupture from HES-APC or Civil Registrations of Death. Only the specific neurosurgery unit will receive any contact related to their original data collection. Data will not be shared across units.
The Data will be stored on servers at UHS. The Data will not be stored in another location.
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.
The Data will be accessed onsite at UHS and via remote access
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 England and Wales at any time.
Access is restricted to employees or agents of UHS 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 data obtained from UK neurosurgery units and renal units supplied by UHS.
Further linkage for Civil Registrations of Death will be required to the Patient Episode Database for Wales (PEDW). Since the data from NHS England data covers England and Wales, individuals may appear in both. PEDW results will also be pseudonymised with a study ID. Any PEDW admissions and NHS England deaths relating to the same patient will be linked by the Study team using the study ID.
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 for analysis.
Researchers from the UHS will process the data for the purposes described above.
Expected output
The expected outputs of the processing will be:
• A report of findings to the study sponsor and the Confidentiality Advisory Group on an annual basis.
• Submissions to peer reviewed journals, these will be journals catering for neurosurgery and stroke clinicians.
• Presentations at neurosurgery and stroke conferences including the British Neurovascular Group.
• Publication of dashboards: The study has a dedicated website (www.roarstudy.co.uk) where summary data may be published at the end of the study.
• Production of a tool which will be made available. A patient specific online risk calculator will be published on the study website. This calculator will use processed data from the ROAR study in order to provide a specific rupture risk for the patient based on the clinical characteristics they enter. This is available free of charge.
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:
1. Journals
2. Workshops involving Patient feedback groups
3. Social media
4. Industry newsletters
5. Participant newsletters
It is expected that the primary outcomes will be answered by July 2025 at which point the manuscripts for publication will be prepared, if not already published. The online patient calculator will also be ready for launch by this date. Dissemination at conferences will be an ongoing process throughout the study and beyond 2024 as further secondary analysis is conducted.
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD. The team will be publishing a peer-reviewed manuscript on this data.
Expected measurable benefits
The findings of this research study 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 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 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.
• 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).
Members of the public with an unruptured intra-cranial aneurysm are currently subject to both physical and psychological harm. The former due to over/undertreatment from using inaccurate data and the latter due to anxiety from having to make treatment decision using unreliable data. It is hoped that by disseminating the results to clinicians and the public both sources for harm will be abated.
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.
Benefits reported so far
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.; National Health Service Act 2006 - s251 - 'Control of patient information'.
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Civil Registrations of Death | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Demographics | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Diagnostic Imaging Data Set (DID) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Identifiable | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Maternity Services Data Set (MSDS) v1.5 | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Maternity Services Data Set (MSDS) v2 | Identifiable | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were applied to all 124 files released under this agreement, across every version. About opt-outs
Files released against version 3.3 of this agreement, summarised by dataset.
| Dataset | Files | First released | Last released | Opt-outs applied |
|---|---|---|---|---|
| Diagnostic Imaging Data Set (DID) | 1 | February 2026 | February 2026 | Yes |
Version history
The register lists each renewal of this agreement as a separate row. This site has 4 versions.
DARS-NIC-334745-L4J6P-v3.3 3 December 2025 to 2 December 2028
- Title
- Risk Of Aneurysm Rupture Study (ROAR)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 6
- Files released
- 1
Datasets: Civil Registrations of Death; Demographics; Diagnostic Imaging Data Set (DID); Hospital Episode Statistics Admitted Patient Care (HES APC); Maternity Services Data Set (MSDS) v1.5; Maternity Services Data Set (MSDS) v2
What changed from DARS-NIC-334745-L4J6P-v2.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-12-03 | |
| End date | 2028-12-02 |
Datasets: + Diagnostic Imaging Data Set (DID)
Objective for processing
[22 paragraphs unchanged] • Diagnostic Imaging Dataset (DID) - Imaging will be subjected to advanced image analysis (e.g. Computational Fluid Dynamics (CFD) and Convolutional Neural Networks (CNN)) to derive new predictors of rupture to be tested in the main ROAR prediction models. In order to aid in the identification of radiological investigations for these patients, which could have been performed across the UK, the cohort will be linked to the Diagnostic Imaging Dataset by NHS England for data on the scans these patient have received. [19 paragraphs unchanged]
Processing activities
[1 paragraph unchanged]
NHS England will then provide the relevant records from the Hospital Episode Statistics Admitted Patient Care (HES APC), Civil Registrations of Death,
Demographics
Demographics, Diagnostic Imaging Dataset
and Maternity Services datasets to UHS.
[20 paragraphs unchanged]
Unchanged: Expected output, Expected measurable benefits, Benefits reported.
DARS-NIC-334745-L4J6P-v2.2 16 August 2024 to 15 August 2027
- Title
- Risk Of Aneurysm Rupture Study (ROAR)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 103
Datasets: Civil Registrations of Death; Demographics; Hospital Episode Statistics Admitted Patient Care (HES APC); Maternity Services Data Set (MSDS) v1.5; Maternity Services Data Set (MSDS) v2
What changed from DARS-NIC-334745-L4J6P-v1.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Title | Risk Of Aneurysm Rupture Study (ROAR) | |
| Start date | 2024-08-16 | |
| End date | 2027-08-15 |
Datasets: + Demographics; + MSDS (Maternity Services Data Set) v1.5; + MSDS (Maternity Services Data Set) v2.0
Objective for processing
[1 paragraph unchanged]
Risk Of Aneurysm Rupture Study
(ROAR)
The following is a summary of the aims of the research project provided by the UHS:
“Unruptured intracranial aneurysms (a bulge in a blood vessel caused by a weakness in the blood vessel wall) are a common condition (3% of the population) which have life threatening implications for the patient if they rupture. Patients who suffer a ruptured brain aneurysm are frequently left dead or severely disabled. Decision making around the prophylactic treatment (a prophylactic is a medication, or a treatment designed and used to prevent a disease from occurring) of unruptured brain aneurysms is part of routine practice in neurosurgery and the results from this study will help predict a patient's risk of rupture and thus guide the clinical management of these patients towards the lowest risk option possible.
The aim of this study is to describe the natural history of unruptured intracranial aneurysms (UIA) in England. The condition is of great clinical importance because of the high prevalence of UIA with diagnoses continually increasing due to the widespread availability of imaging and increasing age of the population. Despite this there are great uncertainties as to how to manage patients with UIA. The management is fundamentally based on the balance of risk between treatment and the natural history of the UIA. However, as described above, our understanding of UIA natural history is flawed and thus currently patients are potentially being subjected to the risk of over- or under-treatment. The possible negative outcomes from either unnecessary prophylactic aneurysm treatment or from subarachnoid haemorrhage (SAH), include stroke, long term disability and death, and thus it is crucial that patients are provided with most accurate information possible for their treatment decisions.”
This amendment now seeks the inclusion of the Maternity Services Data Set to help answer the longstanding, and unanswered, clinical question - what advice to give to women with unruptured aneurysms who want to get pregnant? Patients want to know what is the risk of the aneurysm rupturing during pregnancy, should their aneurysm be treated before they get pregnant and what are the rupture risks during delivery. The implications of rupture during pregnancy, in addition to the neurological injury to the patient from subarachnoid haemorrhage, include the potential for harm to the foetus from ionising radiation used to investigate and treat ruptured aneurysms. Blood pressure changes during gestation and during delivery may increase the risk of aneurysm rupture and many women are advised, or opt themselves, for Caesarean sections to mitigate this risk however there is currently no evidence to actually support this. Within the ROAR cohort of patients with unruptured aneurysms there will be a subset of women who were pregnant after their aneurysm was diagnosed. The purpose of the amendment is to evaluate the role of pregnancy as a risk factor for aneurysm rupture by identifying all episodes of pregnancy for women in the ROAR cohort, how many women had a ruptured aneurysm during pregnancy and what are the risk factors associated with rupture during delivery.
[1 paragraph unchanged]
“Unruptured intracranial aneurysms (a bulge in a blood vessel caused by a weakness in the blood vessel wall) are a common condition (3% of the population) which have life threatening implications for the patient if they rupture. Patients who suffer a ruptured brain aneurysm are frequently left dead or severely disabled. Decision making around the prophylactic treatment (a prophylactic is a medication, or a treatment designed and used to prevent a disease from occurring) of unruptured brain aneurysms is part of routine practice in neurosurgery and the results from this study will help predict a patient's risk of rupture and thus guide the clinical management of these patients towards the lowest risk option possible.
Primary Aims:
"The aim of this study is therefore to describe the natural history of unruptured intracranial aneurysms (UIA) in Great Britain. The condition is of great clinical importance because of the high prevalence of UIA with diagnoses continually increasing due to the widespread availability of imaging and increasing age of the population. Despite this there are great uncertainties as to how to manage patients with UIA. The management is fundamentally based on the balance of risk between treatment and the natural history of the UIA. However, as described above, our understanding of UIA natural history is flawed and thus currently patients are potentially being subjected to the risk of over- or under-treatment. The possible negative outcomes from either unnecessary prophylactic aneurysm treatment or from subarachnoid haemorrhage (SAH), include stroke, long term disability and death, and thus it is crucial that patients are provided with most accurate information possible for their treatment decisions.”
Aim 1 - To validate the PHASES score in a UK population.
Aim 2 - To develop a new prediction model including all described predictors of risk.
Aim 3 - To report long-term risk of aneurysm rupture.
Secondary Aims:
Aim 4 – To develop risk models of aneurysm growth.
Aim 5 – To evaluate the efficacy of aneurysm screening regimens.
Aim 6 – To develop and evaluate new radiological predictors of aneurysm growth and rupture.
Aim 7 – To develop a prognostic rupture model for patients with ADPKD.
Aim 8 – To develop risk models for aneurysm rupture during pregnancy and delivery.
[1 paragraph unchanged]
• Hospital Episode Statistics (HES) Admitted Patient Care – necessary to provide
[31 words unchanged]
nearly all ruptures who don't die immediately will get admitted to hospital.
All potential ruptures identified will be validated to confirm true ruptures from miscoding.
• Civil Registration
Mortality
of Death
– necessary for two purposes. The date of death for those patients
[36 words unchanged]
without attending hospital and thus will not be included in APC data.
The data are required to establish a new prediction model based on risk factors that have not previously been considered or recorded in the initial cohort data collection. There are many more risks which have not been considered which could impact UIA’s.
• Patient Demographic Service - Required in order to be able to check successful linkage of patients data, to ensure that where data is missing, the reason for that missing data is known. Without the amendment, the aneurysm rupture rates produced by this study will be unreliable as they will contain an unmeasured degree of inaccuracy. Whilst this inaccuracy is likely to only be a few percent based on pilot data it is important that data be as accurate as possible.
The level of the data will be identifiable because UHS holds the identifying details. However, the data that will be disseminated by NHS England will contain no identifying details.
• Maternity Services Data Set - a secondary outcome of the study is to measure the risk of pregnancy and different delivery methods on aneurysm rupture. In order to determine the rupture rate during pregnancy it is necessary to know details of all pregnancies that occurred in this cohort.
The level of the Data will be identifiable because UHS holds the identifying details of the cohort. Identifiable data include date/cause of death (where applicable) which is needed for censoring the length of follow-up and serves as the date of aneurysm rupture for out of hospital deaths. The date of death will be anonymised into a duration of follow-up within 60 days of data receipt in accordance with the CAG support. Additionally, NHSE will return from the Demographics data identifiers pertaining to date of birth, names and postcode for validation purposes where they will be checked against the data held by the recipient to confirm the correct patient linkage. All identifiers, both those initially held by UHS and those received from NHSE will be deleted within 60 days of data receipt (with the exception of the CAG extension required to receive scans through PACS).
[1 paragraph unchanged]
- Limited to data for a study cohort identified by neurosurgery units and renal units in the UK and then sent to UHS –
Eligibility:
Limited to adults aged 18 years or older with an Intracranial intradural unruptured aneurysm confirmed on angiogram (a type of X-ray used to check blood vessels), and a diagnosis of UIA between January 2006 and December 2020.
- Age 18 years or older.
- Limited to data between 2006 and latest availability (expected 2024).
- Intracranial intradural unruptured aneurysm.
- Confirmed on angiogram (a type of X-ray used to check blood vessels).
- Diagnosis of UIA between January 2006 and December 2020.
- Limited to data between 2006 and latest availability (expected 2023).
[2 paragraphs unchanged]
UHS is the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The reason the cohort is limited to 'over 18's' is that cerebral aneurysms are seen with advancing age, the average age of diagnosis is in the 50s. Aneurysms are rare in children and when they do occur they are likely due to a different underlying mechanism and so their natural history is expected to be different. Including patients <18 years old would interfere with the accuracy of the results.
UHS is the research sponsor and controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
[5 paragraphs unchanged]
The funding will be provided by National Institute for Health and Care Research (NIHR). Funding is in place until
31/07/2024.
31/08/2024. Previous iterations of this agreement also had an additional funding source of Smile4Wessex. Funding to continue the work described will be sought on an ongoing basis.
Previous iterations of this agreement also had an additional funding source of Smile4Wessex. In version 1.3 of the agreement funding will be solely provided by NIHR only.
University of Oxford are not accessing the data but acting in an advisory capacity to the study. No NHS England data will be shared with the University of Oxford.
Funding to continue the work described will be sought on an ongoing basis.
University of Oxford are not accessing the data but acting in an advisory capacity to the study.
[2 paragraphs unchanged]
The team therefore organised a
A
workgroup to discuss UIA research
was organised
(advertised via the support group page on social media) where it was
[15 words unchanged]
patients do not want their management to be randomised and therefore a
Random
Randomised
Controlled Trial (RCT) is unlikely to succeed. Consequently, a better understanding of
[15 words unchanged]
lifetime risks, are what is relevant to patients. On the basis of
this
this, a observational study of
the
team designed an observational
natural history
was designed
rather than an
attempt at an
RCT.
[1 paragraph unchanged]
Processing activities
No further data will flow under this version of the Data Sharing Agreement.
Neurosurgery units and renal units in the UK will send the study cohort to UHS. UHS will then transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, full name, Date of Birth, Postcode, gender, and a unique person ID) for the cohort to be linked with NHS England data.
Neurosurgery units and renal units in the UK will send the study cohort to UHS. UHS will then transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, full name, Date of Birth, Postcode, and a unique person ID) for the cohort to be linked with NHS England data.
NHS England will then provide the relevant records from the Hospital Episode Statistics Admitted Patient Care (HES APC), Civil Registrations of Death, Demographics and Maternity Services datasets to UHS.
NHS England data will provide the relevant records from the Hospital Episode Statistics (HES) Admitted Patient Care dataset and Civil Registration Mortality dataset to UHS.
The data 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 contain identifying data.
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.
Date of death will be converted into a length of follow-up duration in days within 60 days of data receipt by UHS. Forename, surname, date of birth and postcode from the demographic data will be checked against the data held by the recipient to confirm the correct patient linkage, these data points will be deleted within 60 days of data receipt.
Following processing of the NHS England data, the study team will contact the specific neurosurgery unit and use the
person centred
study
ID for the unit to review any radiology imaging and/or discharge summaries
[16 words unchanged]
in their coding. This process will only use the date of potential
rupture.
rupture from HES-APC or Civil Registrations of Death.
Only the specific neurosurgery unit will receive any contact related to their original data collection. Data will not be shared
cross
across
units.
The
data
Data
will be stored on servers at
University Southampton NHS Foundation Trust.
UHS. The Data will not be stored in another location.
The Data will be accessed by authorised personnel.
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.
In the event that Data will be accessed 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.
The Data will be accessed onsite at UHS and via remote access
Personnel are prohibited from downloading or copying data to local devices.
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).
[1 paragraph unchanged]
Access is restricted to employees or agents of UHS who have authorisation from the Chief Investigator.
All personnel accessing the data have been appropriately trained in data protection and confidentiality.
All personnel accessing the data have been appropriately trained in data protection and confidentiality.
[1 paragraph unchanged]
Further linkage
for Civil Registrations of Death
will be required to the Patient Episode Database for Wales (PEDW). Since
[11 words unchanged]
may appear in both. PEDW results will also be pseudonymised with a
person centred
study
ID. Any PEDW admissions and NHS England deaths relating to the same patient will be linked by the Study team using the
person centred
study
ID.
[2 paragraphs unchanged]
Expected output
[13 paragraphs unchanged]
It is expected that the primary outcomes will be answered by July
2024
2025
at which point the manuscripts for publication will be prepared, if not
[23 words unchanged]
throughout the study and beyond 2024 as further secondary analysis is conducted.
[1 paragraph unchanged]
Unchanged: Expected measurable benefits, Benefits reported.
Objective for processing
University Hospitals Southampton NHS Foundation Trust (UHS) requires access to NHS England data for the purpose of the following research project:
Risk Of Aneurysm Rupture Study (ROAR)
The following is a summary of the aims of the research project provided by the UHS:
“Unruptured intracranial aneurysms (a bulge in a blood vessel caused by a weakness in the blood vessel wall) are a common condition (3% of the population) which have life threatening implications for the patient if they rupture. Patients who suffer a ruptured brain aneurysm are frequently left dead or severely disabled. Decision making around the prophylactic treatment (a prophylactic is a medication, or a treatment designed and used to prevent a disease from occurring) of unruptured brain aneurysms is part of routine practice in neurosurgery and the results from this study will help predict a patient's risk of rupture and thus guide the clinical management of these patients towards the lowest risk option possible.
The aim of this study is to describe the natural history of unruptured intracranial aneurysms (UIA) in England. The condition is of great clinical importance because of the high prevalence of UIA with diagnoses continually increasing due to the widespread availability of imaging and increasing age of the population. Despite this there are great uncertainties as to how to manage patients with UIA. The management is fundamentally based on the balance of risk between treatment and the natural history of the UIA. However, as described above, our understanding of UIA natural history is flawed and thus currently patients are potentially being subjected to the risk of over- or under-treatment. The possible negative outcomes from either unnecessary prophylactic aneurysm treatment or from subarachnoid haemorrhage (SAH), include stroke, long term disability and death, and thus it is crucial that patients are provided with most accurate information possible for their treatment decisions.”
This amendment now seeks the inclusion of the Maternity Services Data Set to help answer the longstanding, and unanswered, clinical question - what advice to give to women with unruptured aneurysms who want to get pregnant? Patients want to know what is the risk of the aneurysm rupturing during pregnancy, should their aneurysm be treated before they get pregnant and what are the rupture risks during delivery. The implications of rupture during pregnancy, in addition to the neurological injury to the patient from subarachnoid haemorrhage, include the potential for harm to the foetus from ionising radiation used to investigate and treat ruptured aneurysms. Blood pressure changes during gestation and during delivery may increase the risk of aneurysm rupture and many women are advised, or opt themselves, for Caesarean sections to mitigate this risk however there is currently no evidence to actually support this. Within the ROAR cohort of patients with unruptured aneurysms there will be a subset of women who were pregnant after their aneurysm was diagnosed. The purpose of the amendment is to evaluate the role of pregnancy as a risk factor for aneurysm rupture by identifying all episodes of pregnancy for women in the ROAR cohort, how many women had a ruptured aneurysm during pregnancy and what are the risk factors associated with rupture during delivery.
The following is a summary of the aims of the research project provided by UHS:
Primary Aims:
Aim 1 - To validate the PHASES score in a UK population.
Aim 2 - To develop a new prediction model including all described predictors of risk.
Aim 3 - To report long-term risk of aneurysm rupture.
Secondary Aims:
Aim 4 – To develop risk models of aneurysm growth.
Aim 5 – To evaluate the efficacy of aneurysm screening regimens.
Aim 6 – To develop and evaluate new radiological predictors of aneurysm growth and rupture.
Aim 7 – To develop a prognostic rupture model for patients with ADPKD.
Aim 8 – To develop risk models for aneurysm rupture during pregnancy and delivery.
The following NHS England Data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care – necessary to provide information on hospital admissions for aneurysm rupture events or elective aneurysm treatment. Rupture is the primary outcome and elective treatment is a censoring event. Aneurysm rupture produces severe symptoms and thus nearly all ruptures who don't die immediately will get admitted to hospital. All potential ruptures identified will be validated to confirm true ruptures from miscoding.
• Civil Registration of Death – necessary for two purposes. The date of death for those patients who die from causes other than aneurysm rupture will be a censoring event when a patient’s aneurysm rupture risk stops. The cause of death is important to identify patients who had an aneurysm rupture and died without attending hospital and thus will not be included in APC data.
• Patient Demographic Service - Required in order to be able to check successful linkage of patients data, to ensure that where data is missing, the reason for that missing data is known. Without the amendment, the aneurysm rupture rates produced by this study will be unreliable as they will contain an unmeasured degree of inaccuracy. Whilst this inaccuracy is likely to only be a few percent based on pilot data it is important that data be as accurate as possible.
• Maternity Services Data Set - a secondary outcome of the study is to measure the risk of pregnancy and different delivery methods on aneurysm rupture. In order to determine the rupture rate during pregnancy it is necessary to know details of all pregnancies that occurred in this cohort.
The level of the Data will be identifiable because UHS holds the identifying details of the cohort. Identifiable data include date/cause of death (where applicable) which is needed for censoring the length of follow-up and serves as the date of aneurysm rupture for out of hospital deaths. The date of death will be anonymised into a duration of follow-up within 60 days of data receipt in accordance with the CAG support. Additionally, NHSE will return from the Demographics data identifiers pertaining to date of birth, names and postcode for validation purposes where they will be checked against the data held by the recipient to confirm the correct patient linkage. All identifiers, both those initially held by UHS and those received from NHSE will be deleted within 60 days of data receipt (with the exception of the CAG extension required to receive scans through PACS).
The data will be minimised as follows:
- Limited to data for a study cohort identified by neurosurgery units and renal units in the UK and then sent to UHS – Limited to adults aged 18 years or older with an Intracranial intradural unruptured aneurysm confirmed on angiogram (a type of X-ray used to check blood vessels), and a diagnosis of UIA between January 2006 and December 2020.
- Limited to data between 2006 and latest availability (expected 2024).
- Limited to conditions relevant to the study identified by specific ICD or OPCS codes.
- Limited to pseudonymised data only when accessed for analysis purposes.
The reason the cohort is limited to 'over 18's' is that cerebral aneurysms are seen with advancing age, the average age of diagnosis is in the 50s. Aneurysms are rare in children and when they do occur they are likely due to a different underlying mechanism and so their natural history is expected to be different. Including patients <18 years old would interfere with the accuracy of the results.
UHS is the research sponsor and 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 it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding will be provided by National Institute for Health and Care Research (NIHR). Funding is in place until 31/08/2024. Previous iterations of this agreement also had an additional funding source of Smile4Wessex. Funding to continue the work described will be sought on an ongoing basis.
University of Oxford are not accessing the data but acting in an advisory capacity to the study. No NHS England data will be shared with the University of Oxford.
A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the data for the purposes described above.
The PPIE group is a forum for patients and carers with SAH and UIA established in 2001 and available to over 2000 patients during that time. It runs bi-monthly meetings with typically 30 to 50 participants and has been on social media since 2016 (187 current members). Recurrently the main themes at Q&A are around anxiety, and more specifically “what is the risk I will have a haemorrhage”. These observations of patient concerns were mirrored closely in an analysis of online discussion groups of patients with UIA5.
A workgroup to discuss UIA research was organised (advertised via the support group page on social media) where it was confirmed that better decision making on aneurysm treatment is the main concern for patients, but patients do not want their management to be randomised and therefore a Randomised Controlled Trial (RCT) is unlikely to succeed. Consequently, a better understanding of the natural history of UIA was deemed the top priority and that long term, ideally lifetime risks, are what is relevant to patients. On the basis of this, a observational study of the natural history was designed rather than an RCT.
The Trial Management Group (TMG) includes a PPIE lead who is a patient representative with personal experience of both unruptured and ruptured aneurysms. They attend all TMG meetings. The team are also holding PPI meetings every 6 months which will be open to stakeholders from across the UK. These meetings will help guide secondary analysis and the methods of disseminating the results so that they are tailored to the lay audience’s needs.
Expected output
The expected outputs of the processing will be:
• A report of findings to the study sponsor and the Confidentiality Advisory Group on an annual basis.
• Submissions to peer reviewed journals, these will be journals catering for neurosurgery and stroke clinicians.
• Presentations at neurosurgery and stroke conferences including the British Neurovascular Group.
• Publication of dashboards: The study has a dedicated website (www.roarstudy.co.uk) where summary data may be published at the end of the study.
• Production of a tool which will be made available. A patient specific online risk calculator will be published on the study website. This calculator will use processed data from the ROAR study in order to provide a specific rupture risk for the patient based on the clinical characteristics they enter. This is available free of charge.
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:
1. Journals
2. Workshops involving Patient feedback groups
3. Social media
4. Industry newsletters
5. Participant newsletters
It is expected that the primary outcomes will be answered by July 2025 at which point the manuscripts for publication will be prepared, if not already published. The online patient calculator will also be ready for launch by this date. Dissemination at conferences will be an ongoing process throughout the study and beyond 2024 as further secondary analysis is conducted.
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD. The team will be publishing a peer-reviewed manuscript on this data.
Benefits reported
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD.
DARS-NIC-334745-L4J6P-v1.4 12 December 2023 to 11 December 2024
- Title
- Risk Of Aneurysm Rupture Study
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC)
What changed from DARS-NIC-334745-L4J6P-v0.7
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2023-12-12 | |
| End date | 2024-12-11 |
Objective for processing
University Hospitals Southampton NHS Foundation Trust (UHS) requires access to NHS
Digital
England
data for the purpose of the following research project:
[4 paragraphs unchanged]
The following NHS
Digital
England
data will be accessed:
[3 paragraphs unchanged]
The level of the data will be identifiable because UHS holds the identifying details. However, the data that will be disseminated by NHS
Digital
England
will contain no identifying details.
[15 paragraphs unchanged]
The funding comes from multiple sources. Current funders include:
The funding will be provided by National Institute for Health and Care Research (NIHR). Funding is in place until 31/07/2024.
• National Institute for Health and Care Research (NIHR) – Funding is in place until 31/07/2024.
Previous iterations of this agreement also had an additional funding source of Smile4Wessex. In version 1.3 of the agreement funding will be solely provided by NIHR only.
• Smile4Wessex – Funding is in place until 14/06/2024.
• Polycystic Kidney Charity – Funding is in place until 30/09/2022.
[6 paragraphs unchanged]
Processing activities
Neurosurgery units and renal units in the UK will send the study cohort to UHS. UHS will then transfer data to NHS Digital. The data will consist of identifying details (specifically NHS Number, full name, Date of Birth, Postcode, and a unique person ID) for the cohort to be linked with NHS Digital data.
No further data will flow under this version of the Data Sharing Agreement.
NHS Digital data will provide the relevant records from the Hospital Episode Statistics (HES) Admitted Patient Care dataset and Civil Registration Mortality dataset to UHS.
Neurosurgery units and renal units in the UK will send the study cohort to UHS. UHS will then transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, full name, Date of Birth, Postcode, and a unique person ID) for the cohort to be linked with NHS England data.
NHS England data will provide the relevant records from the Hospital Episode Statistics (HES) Admitted Patient Care dataset and Civil Registration Mortality dataset to UHS.
[1 paragraph unchanged]
Following processing of the NHS
Digital
England
data, the study team will contact the specific neurosurgery unit and use
[54 words unchanged]
to their original data collection. Data will not be shared cross units.
[1 paragraph unchanged]
The data will be accessed either onsite at the premises of UHS or by authorised personnel via remote access. The data will always remain on the servers at UHS.
The Data will be accessed by authorised personnel.
In the event that Data will be accessed 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.
[5 paragraphs unchanged]
Further linkage will be required to the Patient Episode Database for Wales (PEDW). Since the data from NHS
Digital
England
data covers England and Wales, individuals may appear in both. PEDW results will also be pseudonymised with a person centred ID. Any PEDW admissions and NHS
Digital
England
deaths relating to the same patient will be linked by the Study team using the person centred ID.
[2 paragraphs unchanged]
Expected output
[6 paragraphs unchanged]
The outputs will not contain NHS
Digital
England
data and will only contain aggregated information with small numbers suppressed as
[5 words unchanged]
relevant disclosure rules for the dataset(s) from which the information was derived.
[7 paragraphs unchanged]
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD. The team will be publishing a peer-reviewed manuscript on this data.
Benefits reported
Yielded Benefits is not a requirement for new applications.
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD.
Unchanged: Expected measurable benefits.
Objective for processing
University Hospitals Southampton NHS Foundation Trust (UHS) requires access to NHS England data for the purpose of the following research project:
Risk Of Aneurysm Rupture Study
The following is a summary of the aims of the research project provided by UHS:
“Unruptured intracranial aneurysms (a bulge in a blood vessel caused by a weakness in the blood vessel wall) are a common condition (3% of the population) which have life threatening implications for the patient if they rupture. Patients who suffer a ruptured brain aneurysm are frequently left dead or severely disabled. Decision making around the prophylactic treatment (a prophylactic is a medication, or a treatment designed and used to prevent a disease from occurring) of unruptured brain aneurysms is part of routine practice in neurosurgery and the results from this study will help predict a patient's risk of rupture and thus guide the clinical management of these patients towards the lowest risk option possible.
"The aim of this study is therefore to describe the natural history of unruptured intracranial aneurysms (UIA) in Great Britain. The condition is of great clinical importance because of the high prevalence of UIA with diagnoses continually increasing due to the widespread availability of imaging and increasing age of the population. Despite this there are great uncertainties as to how to manage patients with UIA. The management is fundamentally based on the balance of risk between treatment and the natural history of the UIA. However, as described above, our understanding of UIA natural history is flawed and thus currently patients are potentially being subjected to the risk of over- or under-treatment. The possible negative outcomes from either unnecessary prophylactic aneurysm treatment or from subarachnoid haemorrhage (SAH), include stroke, long term disability and death, and thus it is crucial that patients are provided with most accurate information possible for their treatment decisions.”
The following NHS England data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care – necessary to provide information on hospital admissions for aneurysm rupture events or elective aneurysm treatment. Rupture is the primary outcome and elective treatment is a censoring event. Aneurysm rupture produces severe symptoms and thus nearly all ruptures who don't die immediately will get admitted to hospital.
• Civil Registration Mortality – necessary for two purposes. The date of death for those patients who die from causes other than aneurysm rupture will be a censoring event when a patient’s aneurysm rupture risk stops. The cause of death is important to identify patients who had an aneurysm rupture and died without attending hospital and thus will not be included in APC data.
The data are required to establish a new prediction model based on risk factors that have not previously been considered or recorded in the initial cohort data collection. There are many more risks which have not been considered which could impact UIA’s.
The level of the data will be identifiable because UHS holds the identifying details. However, the data that will be disseminated by NHS England will contain no identifying details.
The data will be minimised as follows:
- Limited to data for a study cohort identified by neurosurgery units and renal units in the UK and then sent to UHS – Eligibility:
- Age 18 years or older.
- Intracranial intradural unruptured aneurysm.
- Confirmed on angiogram (a type of X-ray used to check blood vessels).
- Diagnosis of UIA between January 2006 and December 2020.
- Limited to data between 2006 and latest availability (expected 2023).
- Limited to conditions relevant to the study identified by specific ICD or OPCS codes.
- Limited to pseudonymised data only when accessed for analysis purposes.
UHS is the data 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 it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding will be provided by National Institute for Health and Care Research (NIHR). Funding is in place until 31/07/2024.
Previous iterations of this agreement also had an additional funding source of Smile4Wessex. In version 1.3 of the agreement funding will be solely provided by NIHR only.
Funding to continue the work described will be sought on an ongoing basis.
University of Oxford are not accessing the data but acting in an advisory capacity to the study.
A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the data for the purposes described above.
The PPIE group is a forum for patients and carers with SAH and UIA established in 2001 and available to over 2000 patients during that time. It runs bi-monthly meetings with typically 30 to 50 participants and has been on social media since 2016 (187 current members). Recurrently the main themes at Q&A are around anxiety, and more specifically “what is the risk I will have a haemorrhage”. These observations of patient concerns were mirrored closely in an analysis of online discussion groups of patients with UIA5.
The team therefore organised a workgroup to discuss UIA research (advertised via the support group page on social media) where it was confirmed that better decision making on aneurysm treatment is the main concern for patients, but patients do not want their management to be randomised and therefore a Random Controlled Trial (RCT) is unlikely to succeed. Consequently, a better understanding of the natural history of UIA was deemed the top priority and that long term, ideally lifetime risks, are what is relevant to patients. On the basis of this the team designed an observational natural history rather than an attempt at an RCT.
The Trial Management Group (TMG) includes a PPIE lead who is a patient representative with personal experience of both unruptured and ruptured aneurysms. They attend all TMG meetings. The team are also holding PPI meetings every 6 months which will be open to stakeholders from across the UK. These meetings will help guide secondary analysis and the methods of disseminating the results so that they are tailored to the lay audience’s needs.
Expected output
The expected outputs of the processing will be:
• A report of findings to the study sponsor and the Confidentiality Advisory Group on an annual basis.
• Submissions to peer reviewed journals, these will be journals catering for neurosurgery and stroke clinicians.
• Presentations at neurosurgery and stroke conferences including the British Neurovascular Group.
• Publication of dashboards: The study has a dedicated website (www.roarstudy.co.uk) where summary data may be published at the end of the study.
• Production of a tool which will be made available. A patient specific online risk calculator will be published on the study website. This calculator will use processed data from the ROAR study in order to provide a specific rupture risk for the patient based on the clinical characteristics they enter. This is available free of charge.
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:
1. Journals
2. Workshops involving Patient feedback groups
3. Social media
4. Industry newsletters
5. Participant newsletters
It is expected that the primary outcomes will be answered by July 2024 at which point the manuscripts for publication will be prepared, if not already published. The online patient calculator will also be ready for launch by this date. Dissemination at conferences will be an ongoing process throughout the study and beyond 2024 as further secondary analysis is conducted.
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD. The team will be publishing a peer-reviewed manuscript on this data.
Benefits reported
The pilot results have allowed the team to validate the accuracy of the HES and CRD databases for identifying ruptured aneurysms in a subgroup of patients. The detection rate is >98% which supports the study design to use these databases and gives clinicians objective evidence to trust HES/CRD as a source of research data both for the final ROAR study outputs and any further work done using HES/CRD.
DARS-NIC-334745-L4J6P-v0.7 12 December 2022 to 11 December 2023
- Title
- Risk Of Aneurysm Rupture Study
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 20
Datasets: Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC)
Objective for processing
University Hospitals Southampton NHS Foundation Trust (UHS) requires access to NHS Digital data for the purpose of the following research project:
Risk Of Aneurysm Rupture Study
The following is a summary of the aims of the research project provided by UHS:
“Unruptured intracranial aneurysms (a bulge in a blood vessel caused by a weakness in the blood vessel wall) are a common condition (3% of the population) which have life threatening implications for the patient if they rupture. Patients who suffer a ruptured brain aneurysm are frequently left dead or severely disabled. Decision making around the prophylactic treatment (a prophylactic is a medication, or a treatment designed and used to prevent a disease from occurring) of unruptured brain aneurysms is part of routine practice in neurosurgery and the results from this study will help predict a patient's risk of rupture and thus guide the clinical management of these patients towards the lowest risk option possible.
"The aim of this study is therefore to describe the natural history of unruptured intracranial aneurysms (UIA) in Great Britain. The condition is of great clinical importance because of the high prevalence of UIA with diagnoses continually increasing due to the widespread availability of imaging and increasing age of the population. Despite this there are great uncertainties as to how to manage patients with UIA. The management is fundamentally based on the balance of risk between treatment and the natural history of the UIA. However, as described above, our understanding of UIA natural history is flawed and thus currently patients are potentially being subjected to the risk of over- or under-treatment. The possible negative outcomes from either unnecessary prophylactic aneurysm treatment or from subarachnoid haemorrhage (SAH), include stroke, long term disability and death, and thus it is crucial that patients are provided with most accurate information possible for their treatment decisions.”
The following NHS Digital data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care – necessary to provide information on hospital admissions for aneurysm rupture events or elective aneurysm treatment. Rupture is the primary outcome and elective treatment is a censoring event. Aneurysm rupture produces severe symptoms and thus nearly all ruptures who don't die immediately will get admitted to hospital.
• Civil Registration Mortality – necessary for two purposes. The date of death for those patients who die from causes other than aneurysm rupture will be a censoring event when a patient’s aneurysm rupture risk stops. The cause of death is important to identify patients who had an aneurysm rupture and died without attending hospital and thus will not be included in APC data.
The data are required to establish a new prediction model based on risk factors that have not previously been considered or recorded in the initial cohort data collection. There are many more risks which have not been considered which could impact UIA’s.
The level of the data will be identifiable because UHS holds the identifying details. However, the data that will be disseminated by NHS Digital will contain no identifying details.
The data will be minimised as follows:
- Limited to data for a study cohort identified by neurosurgery units and renal units in the UK and then sent to UHS – Eligibility:
- Age 18 years or older.
- Intracranial intradural unruptured aneurysm.
- Confirmed on angiogram (a type of X-ray used to check blood vessels).
- Diagnosis of UIA between January 2006 and December 2020.
- Limited to data between 2006 and latest availability (expected 2023).
- Limited to conditions relevant to the study identified by specific ICD or OPCS codes.
- Limited to pseudonymised data only when accessed for analysis purposes.
UHS is the data 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 it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The funding comes from multiple sources. Current funders include:
• National Institute for Health and Care Research (NIHR) – Funding is in place until 31/07/2024.
• Smile4Wessex – Funding is in place until 14/06/2024.
• Polycystic Kidney Charity – Funding is in place until 30/09/2022.
Funding to continue the work described will be sought on an ongoing basis.
University of Oxford are not accessing the data but acting in an advisory capacity to the study.
A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the data for the purposes described above.
The PPIE group is a forum for patients and carers with SAH and UIA established in 2001 and available to over 2000 patients during that time. It runs bi-monthly meetings with typically 30 to 50 participants and has been on social media since 2016 (187 current members). Recurrently the main themes at Q&A are around anxiety, and more specifically “what is the risk I will have a haemorrhage”. These observations of patient concerns were mirrored closely in an analysis of online discussion groups of patients with UIA5.
The team therefore organised a workgroup to discuss UIA research (advertised via the support group page on social media) where it was confirmed that better decision making on aneurysm treatment is the main concern for patients, but patients do not want their management to be randomised and therefore a Random Controlled Trial (RCT) is unlikely to succeed. Consequently, a better understanding of the natural history of UIA was deemed the top priority and that long term, ideally lifetime risks, are what is relevant to patients. On the basis of this the team designed an observational natural history rather than an attempt at an RCT.
The Trial Management Group (TMG) includes a PPIE lead who is a patient representative with personal experience of both unruptured and ruptured aneurysms. They attend all TMG meetings. The team are also holding PPI meetings every 6 months which will be open to stakeholders from across the UK. These meetings will help guide secondary analysis and the methods of disseminating the results so that they are tailored to the lay audience’s needs.
Expected output
The expected outputs of the processing will be:
• A report of findings to the study sponsor and the Confidentiality Advisory Group on an annual basis.
• Submissions to peer reviewed journals, these will be journals catering for neurosurgery and stroke clinicians.
• Presentations at neurosurgery and stroke conferences including the British Neurovascular Group.
• Publication of dashboards: The study has a dedicated website (www.roarstudy.co.uk) where summary data may be published at the end of the study.
• Production of a tool which will be made available. A patient specific online risk calculator will be published on the study website. This calculator will use processed data from the ROAR study in order to provide a specific rupture risk for the patient based on the clinical characteristics they enter. This is available free of charge.
The outputs will not contain NHS Digital 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:
1. Journals
2. Workshops involving Patient feedback groups
3. Social media
4. Industry newsletters
5. Participant newsletters
It is expected that the primary outcomes will be answered by July 2024 at which point the manuscripts for publication will be prepared, if not already published. The online patient calculator will also be ready for launch by this date. Dissemination at conferences will be an ongoing process throughout the study and beyond 2024 as further secondary analysis is conducted.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
-
January 2023 —
first listed. 1 version: DARS-NIC-334745-L4J6P-v0.7
-
January 2024
1 version added: DARS-NIC-334745-L4J6P-v1.4
-
September 2024
1 version added: DARS-NIC-334745-L4J6P-v2.2
-
February 2026
1 version added: DARS-NIC-334745-L4J6P-v3.3
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-334745-L4J6P, “Risk Of Aneurysm Rupture Study (ROAR)”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-334745-l4j6p/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-334745-L4J6P to see the original rows.