NHS Digital Data Release Register - reformatted

Royal Free London NHS Foundation Trust projects

107 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 Royal Free London NHS Foundation Trust was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Royal Free London NHS Foundation Trust may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Investigation of 2018 National Cancer Diagnosis Audit (NCDA) results in London — DARS-NIC-682529-F0V1M

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2024-08-01 — 2025-07-31 2024.09 — 2024.09.

Access method: One-Off

Data-controller type: ROYAL FREE LONDON NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations
  2. NDRS National Cancer Diagnosis Audit (NCDA)

Objectives:

Royal Free London NHS Foundation Trust requires access to NHS England data for the purpose of the following project: Investigation of 2018 National Cancer Diagnosis Audit (NCDA) results in London.

The following is a summary of the aims of the audit provided by Royal Free London NHS Foundation Trust:

The National Cancer Diagnosis Audit (NCDA) seeks to investigate factors influencing early diagnosis in primary care by asking GPs to provide information about what happened in the leadup to a cancer diagnosis. The audit looks at:

• How many times someone came to see their GP before being referred,
• Symptoms they reported,
• Tests the GP ordered, and
• When and how they were referred to a specialist.

The information GPs provide to the NCDA is combined with information from the National Cancer Registration Service (NDRS) Cancer Registries to understand the whole pathway to cancer diagnosis: from noticing symptoms and going to see the GP, to getting a final diagnosis in specialist care. This helps identify what good practice already exists and can uncover unnecessary or unwarranted delays in cancer diagnosis, which should be addressed to improve care.

In July 2019, the Early Diagnosis workstream of the Transforming Cancer Services Team for London (TCST), Part of the Royal Free Hospital Trust’s Transformation Partners for Health and Care (TPHC) developed a funded incentive scheme for participating practices in London (this was funded by NHS England [NHSE] London region). This led to an unprecedented return of NCDA Data in London and West Essex. London general practices submitted 14,495 audits as part of the 2018/19 round of the NCDA, representing approximately 45% of all cancers diagnosed during this time.

When the TCST fed back this increased return rate to NHSE London and to the constituent Integrated Care Systems (ICSs) via their Early Diagnosis Board, there was interest in understanding the effect of the enhancement, and whether the improved return provided insights that could inform Early Diagnosis work in London.

The incentive scheme prioritised comprehensive submission of audits at Primary Care Network level across the whole region; therefore, the audit Data are likely to provide a good reflection of all cancers diagnosed in London over a year.

This enhanced Data pool (contained within the 2018 NCDA due to the increased return rate) provides the opportunity to expand the analysis of Data within the incentivised regions beyond the national outputs, and the analysis suggested in this protocol provides an opportunity to identify potential factors associated with late-stage diagnosis as well as delayed diagnosis, segmented by demographic categories, stage at diagnosis and tumour type. These findings can then inform and support local planning activities and decisions in collaboration with the London Region, Integrated Care Systems (ICSs) and Cancer Alliances, to increase the potential for earlier diagnosis in future primary care presentations of cancer.

In order to support the earlier diagnosis of cancer in London, Data is needed to identify areas (geographically and pathway based) where patients experience delays. These Data will be used to support planning and service development.

The incentivised, pseudonymised 2018 NCDA Data linked to NDRS Cancer Registrations will be interrogated to identify:

1) Whether the incentivisation has enhanced the representativeness of the cohort,
2) Whether the Data can be used to identify themes associated with late-stage diagnosis,
3) Whether the Data can demonstrate general characteristics of clinical presentation and management in primary care that influence early diagnosis,
4) Whether locally driven safety netting processes are identifiable within the Data,
5) Whether it is possible to identify characteristics specific to particular demographic groups and tumour types that may influence early diagnosis.”

The following NHS England Data will be accessed:
• NDRS Cancer Registration – Linkage to this dataset is to support population analysis, e.g. results by stage, age at diagnosis, ethnicity and gender
• NDRS National Cancer Diagnosis Audit (NCDA) English only 2018 Data – necessary because it will be used to define and identify the cohort of patients required for the analysis and Data will be used in the analysis.

The level of the Data will be pseudonymised.

The Data will be minimised as follows:
• Limited to patients diagnosed with a primary tumour between 1 Jan 2018 to 31 Dec 2018 (as per NCDA 2018 cohort identification) with a linked record within the NCDA.
• Limited to the following geographic areas: patients resident in London and West Essex as defined by Clinical Commissioning Groups (CCG) boundaries (as existed in 2018).

Royal Free London NHS Foundation Trust is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above

The lawful basis for processing personal Data under the UK GDPR is:
Article 6(1)(e) - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller";

This processing is in the public interest because the findings of the work will inform and influence cancer early diagnosis in London, this falls under the “Support for individuals with a particular disability or medical condition” criteria of the Data Protection Act 2018.

The lawful basis for processing special category Data under the UK GDPR is:
Article 9(2)(i) - “processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Domestic Law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy”.

The funding is provided by The Royal Free London NHS Foundation Trust general operations funding, acting as the TPHC at a London level. The funding is specifically for the project described. Funding is in place until at least 31/3/2025. The funder will have no ability to suppress or otherwise limit the publication of findings.

In line with the National Data opt-out policy, opt-outs are not applied because the Data is not Confidential Patient Information as defined in section 251(10) and (11) of the National Health Service Act 2006.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their Data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out.

Expected Benefits:

The use of the Data could support:
• Regional planning and budgeting of early diagnosis programmes linked to primary care.
• Development of programmes based on outcomes of this analysis.
• Identification of local training needs
• Identification of communities where further outreach may be necessary to advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

The following specific benefits to patients are expected as an outcome subject to the findings.
• More rapid identification of people with symptoms of suspected cancer.
• Improved pathways to facilitate early diagnosis once cancer suspected.
• Better training programmes for clinicians – to improve knowledge of common scenarios.
• More specific messages to the public and patients about common presentation scenarios where diagnosis at risk of being delayed.
• Tailored cancer awareness raising action / programmes that address more accurately challenges to ED in specific communities or areas.

It is hoped that through publication of findings in appropriate media, the findings will be collated and presented to relevant groups and meetings to facilitate discussion and action to address issues identified, this may include confirming appropriateness of current policies and programmes or suggestions for changes to these.

The report written by Royal Free London NHS Foundation Trust describing findings that includes options for policy and service responses that addresses specific issues identified to improve cancer early diagnosis outcomes including reducing inequalities in outcomes in London.

The actions that will be taken to optimise the potential public benefits from the use of the Data are:
• Working with regional, ICB, cancer alliance, local government and cancer charities to promote key messages that improve public awareness and help-seeking behaviour.
• Providing information to primary care, community and other NHS services on key messages to promote as above to patients and public e.g. via posters and brief clinical advice.
• Informing Cancer Research UK as they are closely involved in NCDA work in London.

Outputs:

Findings will be collated and presented to relevant groups and meetings to facilitate discussion and action to address issues identified, this may include confirming appropriateness of current policies and programmes or suggestions for changes to these.

Royal Free London NHS Foundation Trust will write a report describing these findings that include options for policy and service responses that addresses specific issues identified to improve cancer early diagnosis outcomes including reducing inequalities in outcomes in London. Data will be presented in the form of visualisations to support the report and any presentations and published with appropriate suppression of small counts as necessary.

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 expected outputs of the processing will be:
• Presentation and report of findings to NHS London regional cancer forums, cancer alliances, expert clinical and patient groups. Royal Free London NHS Foundation Trust hope to have initial findings and reports in place within 3 months of Data release.
• Presentation and report of findings to external stakeholders including local government, cancer charities and academic forums. Royal Free London NHS Foundation Trust hope to have initial findings and reports in place within 3 months of Data release. Further reports/visualisations would be within 4-5 months of the release.
• Presentation at national meetings and conferences including CRUK ED conference. Presentation at conferences would be within the year of Data release, as would any subsequent products.
• Submissions to peer reviewed journals - within one year of analysis.

It is hoped that the outputs would be completed and distributed/communicated to the recipients named above within 6 months of receiving the Data from NHS England.

Processing:

No data will flow to NHS England for the purposes of this Agreement.

NHS England will identify the cohort then provide the linked relevant records from the NDRS Cancer Registration and the NDRS National Cancer Diagnosis Audit (NCDA) datasets to Royal Free London NHS Foundation Trust. The Data will contain no direct identifying data items.

The Data will be stored on servers at sites of the Royal Free London NHS Foundation Trust.

The Data will not be transferred to any other location.

The Data is backed-up at multiple sites in the Royal Free London NHS Foundation Trust.

The Data will be accessed onsite at two locations managed by Royal Free London NHS Foundation Trust and by authorised personnel 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 at any time.

Access is restricted to employees of Royal Free London NHS Foundation Trust who have authorisation from the Principal Investigator.

No other organisation is permitted to access the Data.

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

The data disseminated will not be linked with any other data/ or any data held by Royal Free London NHS Foundation Trust.

Analysts from the Royal Free London NHS Foundation Trust will process the Data for the purposes described above and there will be no requirement and no attempt to reidentify individuals and that any analysis resulting from the released data will not identify individual GP practices.

Phenotyping individuals with elevated mean pulmonary arterial pressure and elevated pulmonary vascular resistance in the United Kingdom — DARS-NIC-306849-M2N0X

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: Yes (NHS Trust)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2021-10-20 — 2024-10-19 2021.12 — 2021.12.

Access method: One-Off

Data-controller type: ROYAL FREE LONDON NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Outpatients
  5. Civil Registrations of Death
  6. Hospital Episode Statistics Accident and Emergency (HES A and E)
  7. Hospital Episode Statistics Admitted Patient Care (HES APC)
  8. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Pulmonary hypertension is when there is increased pressure in the blood vessels of the lungs. This increases the strain that is placed on the right side of the heart, ultimately leading to failure of the right side of the heart to pump against increased pressures. It is diagnosed by haemodynamics obtained by an invasive procedure known as a right heart catheterisation. This is where a catheter (a small hollow tube) is inserted through the vessels and directly measures the pressures in the right side of the heart and arteries in the lung, known as the pulmonary artery. Under the current guidelines a diagnosis of Pulmonary Hypertension is made when the mean pulmonary artery pressure of greater than 25mmHg. A diagnosis of pulmonary hypertension carries high mortality and morbidity. It is known that a mean pulmonary artery pressure of >20mmHg is abnormal, however this does not meet the criteria for Pulmonary Hypertension. These patients are often not formally followed up however, remain symptomatic. Some may even progress to pulmonary hypertension by its current definition. It is important to understand this group of patients who have a mean pulmonary artery pressure less than 25mmHg, however still have abnormal haemodynamics, looking specifically at their baseline characteristics, how the population behaves, progression and most importantly if they demonstrate increased attendances to hospital settings whilst still undiagnosed.

The primary objectives for this study are to look at mortality and admission to hospital for treatment in this population against a control population. This agreement with NHS Digital is a crucial component to meet the primary objectives of the study. Patients with suspected Pulmonary Hypertension will be reviewed in one of the seven specialist tertiary centres across the United Kingdom*: The Royal Free Hospital, The Hammersmith Hospital, The Freeman Hospital, The Royal Brompton, The Royal Papworth Hospital, The Golden Jubilee Hospital (Scotland) and The Royal Hallamshire Hospital. However, these sites may be a distance from their local hospitals. Therefore the capturing of admission to hospital for treatment across the UK will be a sensitive method to understand this population’s progression and if there is health-seeking behaviour. This could have significant implications upon the management of this population and if they should be monitored more closely. The aim of this study is to understand this population, with hope this will mean better surveillance/screening of patients and earlier interventions for patients who require it to promote better outcomes. This will provide a UK perspective on patients who are deemed to have “mild Pulmonary Hypertension” with a mean pulmonary artery pressure between 21-24mmHg. This may also influence guidelines on how to screen and manage this population.

*PLEASE NOTE that this agreement relates to only data from Hospitals in England. The relevant Scottish data will be requested in parallel data sharing agreements with the Scottish equivalent data organisation.

This is a retrospective study looking at all right heart catheters done between 1 January 2009 - 31 December 2016 at the above-listed tertiary centres designated for Pulmonary Hypertension. Patients will be selected for the cohort according to their pulmonary artery pressure; less than 21mmHg, 21-24mmHg and greater 25mmHg; and by peripheral vascular resistance (i.e. the resistance in the pulmonary vessels against blood flow); less than 2 wood units [a], 2-3 wood units and greater than 3 wood units. The less than mean pulmonary artery pressure of 21mmHg with a pulmonary vascular resistance of less than 2 wood units will be considered a control group as this is theoretically considered within the realms of normal cardiovascular haemodynamics (i.e. the study of how blood flows through the cardiovascular system - the heart and blood vessels) . The mean pulmonary artery pressure of greater than 25mmHg will be considered controls for patients who have confirmed pulmonary hypertension by current definition as a comparator.

[a] Wood units. A simplified measurement of pulmonary vascular resistance that uses pressures instead of more complicated units measured by subtracting pulmonary capillary wedge pressure from the mean pulmonary arterial pressure and dividing by cardiac output in litres per minute.

Inclusion criteria includes patients aged over 18, having attended one of the Pulmonary Hypertension tertiary centres in the United Kingdom for assessment. The exclusion criteria include patients who have already had a confirmed diagnosis of Pulmonary hypertension or have been started on medication for pulmonary hypertension. The projected sample size is approximately 2,900 patients for the patients with a mean pulmonary artery pressure of < 25mmHg.

For all cohorts, the baseline investigations will be collected, which are done routinely in clinical practice, to understand demographics of this population and changes in investigations over time, to understand how patients in this population progressed. This will be compared with outcomes. Primary outcome measures are mortality, cause of death and admissions to hospital for treatment. Data on mortality and admission to hospital for treatment will be required from 2009 onwards until March 2020 (though Civil Registration (Deaths) data automated product will be provided up to March 2021). The eligibility period for the study is between 1 January 2009 - 31 December 2016. The observation period is between 2009 and March 2021 however to avoid confounders, the observation period ends in March 2020 before the COVID-19 pandemic started. This will still allow for adequate follow up encounters to assess for progression in this population. The reason for this is that clinical practices throughout the United Kingdom for Pulmonary Hypertension were standardised and there was a drive to make patient data available electronically.

The primary objectives for this study are to understand hard endpoints of this population - in other words - mortality and admission to hospital for treatment. The civil registration (Deaths) data accessed through NHS Digital will allow assessment into if there is an increased mortality compared to the control groups. This will also identify cause of death and if Pulmonary Hypertension was a related or unrelated to cause of death.

Admission to hospital for treatment data analysis is a primary study objective. This data from NHS Digital is crucial in achieving our study objectives and will allow us to assess if there is increased admittance to hospital in this population compared to control groups. This will require reviewing attendances to hospital setting (Accident and Emergency, Admitted patient care and Outpatient services). The total number of hospital attendances and total number of bed days will be compared to the control groups. The hospital attendances will also be categorised into; “related to pulmonary hypertension”, “possibly related to pulmonary hypertension”, “unrelated to pulmonary hypertension” by reviewing diagnosis codes and reason for hospital attendances. The data that is required for admissions to hospital for treatment will provide an understanding of the natural progression of this patient group and to see if there is increased hospital attendance.

The record level NHS Digital data will be pseudonymised with patients being allocated a unique research ID. Any patient identifiers, including date of birth will be removed and the age of the patient at the time of encounter will be used as a surrogate.

Data Minimisation
To minimise the data that is being requested, the Chief Investigator has reviewed the data available in the datasets. This has been carefully selected to ensure only the fields that meet the objectives of this study are requested. Only the datasets that are required have been selected to achieve the outcome of the study. To achieve the objectives of the study, 4 databases have been requested: Civil registrations (Deaths) data, HES Accident and Emergency, HES – Admitted patient care and HES – Outpatient registry.

For admission to hospital for treatment data, patients in this population maybe discharged from tertiary services, however, continue to have ongoing symptoms and in some cases may progress to developing pulmonary hypertension by its current definition. These data sets will allow the study team to understand if patients who are discharged, continue to seek medical attention because of ongoing symptoms or progression and allow us to understand the cause. Hospital encounters will also be categorised into; “related to pulmonary hypertension”, “possibly related to pulmonary hypertension”, “unrelated to pulmonary hypertension” by reviewing diagnosis codes and reason for hospital attendances. The same process will occur with mortality data.

Cause of death will be identified and categorised into, "related to pulmonary hypertension, "possibly related to pulmonary hypertension" and "unrelated to pulmonary hypertension". Although date of death has been requested, this will be used to calculate years of survival from the "index right heart catheterisation", i.e. the time at which "mild pulmonary hypertension" was identified. The record-level pseudonymised NHS digital data will be processed and only aggregated, suppressed data as per the HES analysis guide will be disseminated as outputs.

Patients are reviewed in the seven tertiary centres that specialise in Pulmonary Hypertension. As a result, there is a geographical spread of the patient population throughout the United Kingdom. Most patients are likely to have contact with local hospitals as opposed to a tertiary centre to seek medical attention. NHS Digital is the only option available to be able to collect this data on admission to hospital for treatment across England accurately. NHS Digital, through its safeguards and ability to use linkage with research identifiers as opposed to patient identifiers, allows the least intrusive way of collecting this data.

Legal aspects of data collection:
The Data Controller will process the data under GDPR Article 6 (1) (e). Processing is carried out by an NHS organisation in the public interest, in order to understand and help this patient population in the future.

This is a multi-centre retrospective study, looking at retrospective investigations that were done for clinical need. Relevant patient groups have been involved from the outset to provide input to the design of this study with the assistance of the Pulmonary Hypertension Association (PHA). The PHA ran a survey asking patient population, if there were any objections to the study. Working alongside the PHA a website page has been designed (RESEARCH: Is it possible to diagnose PH earlier? | PHA (phauk.org)) and a leaflet to act as a platform to share information about the study, updates and how to go about registering for the National Opt Out should the patient wish to. To keep patients informed, a newsletter has also been distributed through the Pulmonary Hypertension Association. National Data Opt-Outs will be upheld for this study.

Additionally, under GDPR Article 9(2)(j) processing of Special Category Personal Data is necessary for archiving for research purposes. Data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects.

The patient data will remain pseudonymised, with any patient identifiers removed by NHS Digital prior to dissemination. A unique research ID (Study ID) will be created for each data subject, which will be used for linkage to existing study data. Any outputs will be of aggregated data with small numbers suppressed according to the HES analysis guide, in order to safeguard patient data.

The Royal Free Hospital (a part of the legal entity which is Royal Free Hospital NHS Foundation Trust) will undertake the study and processing of NHS Digital data as data controller and data processor. The outputs will be measured by dissemination of the research outcomes, through scientific committees and publication in scientific journals. This will also be undertaken by the Royal Free Hospital, with support from the other National Pulmonary Hypertension centres in the United Kingdom. This will allow dissemination of research amongst healthcare professionals, scientific bodies, and health policy makers. This will help understand this population better and hopefully aid better outcomes in this population. Publication timelines are forecast for early 2022. The other sites, Statistician and Funders will only have access to aggregated and suppressed data, in accordance with the HES analysis guide.

The Royal Hallamshire Hospital will offer analysis support, having had previous experience with utilising and analysing NHS Digital HES data. However, this will be in an advisory capacity and they will have no access to the record-level pseudonymised NHS Digital data.

The other principle investigators will be involved in interpreting the outcomes of the aggregated and suppressed data only; however, this will involve no data processing.

NHS Digital is content that the purpose of this study is to better phenotype, define and understand a population diagnosed with pulmonary hypertension in the hope that this might lead to future projects to see if earlier intervention and treatment has a positive outcome, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in England.

However, in the interests of full transparency, it is noted here that the funder of the study, Actelion Pharmaceuticals Ltd (a part of the Janssen Pharmaceutical Companies of Johnston & Johnston), will obtain aggregated and suppressed (as per the HES analysis guide) outputs from study data. Thus results of this study may contribute towards commercial work that results in indirect financial benefit for the funder which, in turn, may provide further funding for research into the population.

The funder will have no access to record-level NHS Digital data, nor any involvement in the processing of data, and are not considered a Data Controller for this study. The funder has no ability to suppress the outcomes of this study, nor any say in the management of the outputs and their dissemination to the public and health professionals.

Expected Benefits:

There is no formal pathway currently for patients identified with “mild pulmonary hypertension” in the current guidance. Dissemination of data aims to benefit the provision of health care and adult social care by offering identification and early access to specialist commissioned NHS service to reduce morbidity and mortality to a group of normally healthy, able and socioeconomically productive patients. The evidence gathered would seek to enable revision of Pulmonary Hypertension guidance at the regional tertiary centres, and it is hoped also ESC guidelines as well which would support the promotion of health by improved recognition of this disease by a larger audience. This processing is therefore in the public interest that this study accesses such valuable NHS Digital data to understand this population in greater detail.

Analysis of registry patients has identified circa 2,900 patients between 1 January 2009 - 31 December 2016 inclusive that have a ‘mean pulmonary artery pressure’ (mPAP) of less than 25mmHg, which does not meet the current definition of Pulmonary Hypertension, globally defined as a mean pulmonary artery pressure of >25mmHg. These patients are later clinically referred to Pulmonary Hypertension Services because they remain symptomatic or have an abnormality that has been incidentally identified by another investigation. This figure likely vastly underestimates the ‘real’ number of patients who have abnormal pulmonary circulation and cardiovascular haemodynamics. These individuals would not come to the attention of specialist services as they are not classified by current guidance. There is an increased mortality associated with this group of patients, who do not formally meet the criteria, however, still demonstrate abnormal cardiovascular haemodynamics. It is therefore very important to investigate this population to understand them better and to understand the progression in this disease pathology and factors that predict this. This could benefit patients in the future and is anticipated that it could be fundamental to changing guidelines and identifying patients early in the disease process to allow patients to be appropriately followed up, screened and to intervene earlier to try and limit the progress of the disease before changes to the pulmonary vasculature become irreversible. Understanding “Mild Pulmonary Hypertension” better, will hopefully impact the overall mortality and morbidity and health burden placed on NHS services.

The information provided by NHS Digital is important in achieving the study’s primary end point question: 'Is mortality and admission to hospital for treatment greater in this population?'

Combined with HES and Civil Registrations (Deaths) data, this study offers the potential to determine causation. Untreated, Pulmonary Hypertension does negatively impact on the patient population, the qualitative and quantitative analysis of this data will hopefully allow an insight into silent disease progression, it may also provide information towards understanding which factors influence why some patients do not progress to Pulmonary Hypertension. This is particularly important given the implications of having the diagnosis, including starting unnecessary medications, lifestyle and psychological impact.

Outputs:

The intention is to process and analyse the data by December 2021, with the aim to publish data in Spring 2022. The aim of this UK wide study will be to publish aggregated and suppressed data (as per the HES Analysis guide) in a peer reviewed journal, for instance the European Heart Journal and to present the findings at international conferences, including the European and British Society of Cardiology. The baseline findings will be presented at the Pulmonary Hypertension Forum in November 2021 (without the NHS Digital data as it won't be possible to analyse the data in the short timescale) and then the full baseline findings (with NHS Digital data) will be presented to European Society of Cardiology (ESC) in Spring 2022 . The study team will be working closely with the Pulmonary Hypertension Association to publish update reports of the study for the patient association, to keep patient groups updated on the progress of the study. The seven UK pulmonary hypertension tertiary centres involved in the study also obtain a newsletter monthly to inform them of the progress of the study.

All data outputs will be aggregated and suppressed as per the HES Analysis guide. Data will be tabulated and depicted in a graphical format to ease interpretation of the analysis.

The aggregated and suppressed output results and report will be disseminated to all the principle investigators involved in the study for review and approval prior to publication. Publication target audience will be researchers, scientist and clinicians involved directly in patient care.

The study team have been working closely with the Pulmonary Hypertension Association UK (a charity providing a National information network for patients with Pulmonary Hypertension and their carers) from the outset of the study design. The study team informed the patient forum of their intent and the study purpose, and surveyed their patient population and acted upon their feedback. The study team have provided contact details to offer more information and a point of contact at all points during the study.

The study has a dedicated webpage hosted by Pulmonary Hypertension Association UK. The PHA have no affiliation with the study or this agreement. The PHA have been providing progress notes via this webpage on the study for patients and their carers, and hope to also publish frequent updates on outcomes from the study data analysis.

The study aims to provide an insight into patients with “mild pulmonary hypertension” in the United Kingdom . This is a population that does not currently meet the criteria for formal diagnosis, however, still demonstrates higher mortality and morbidity. It will give an insight into progression and which patient groups need to be monitored more closely. This will hopefully translate into guidance to ensure better outcomes in this population and influence national guidance on Pulmonary Hypertension (European Society of Cardiology – Guidance on Pulmonary Hypertension).

The study is supporting one part-time postgraduate research degree (Doctor of Medicine by Research) at University College London, who is a substantive employee of the Royal Free Hospital. Outputs from the postgraduate research degree will only contain data which is aggregated and suppressed as per the HES Analysis Guide. It is hoped that a journal article will be published in the European Heart Journal in mid-2022, of which open access is provided for some journal articles.

Processing:

The UK phenotyping study for Mild Pulmonary Hypertension, will be collecting retrospective data from 7 sites (6 for England):
The Royal Free Hospital (Royal Free London NHS Foundation Trust - Data controller, Data Processor and study sponsor )
The Royal Brompton Hospital (Guy's and St Thomas' NHS Foundation Trust - previously Royal Brompton and Harefield NHS Foundation Trust)
The Hammersmith Hospital (Imperial College Healthcare NHS Trust)
The Royal Hallamshire Hospital (Sheffield Teaching Hospitals NHS Foundation Trust)
The Royal Papworth Hospital (Royal Papworth Hospital NHS Foundation Trust)
The Freeman Hospital (The Newcastle Upon Tyne Hospitals NHS Foundation Trust)
*** The Golden Jubilee Hospital - not relevant to this agreement as it is Scottish data ***

METHODOLOGY
1. Each site will search their local databases, to identify patients who potentially fulfil the criteria for the study (all patients who have undergone an invasive right heart catheterisations done between 1 January 2009 - 31 December 2016). The NHS numbers will then be sent securely over encrypted NHS email systems from the sites to the Royal Free Hospital. Patients will be allocated a unique study ID at each of the sites. Along with collecting baseline characteristics and investigations, a separate spreadsheet will be generated containing patient details required for the HES process – name, date of birth, NHS number and unique research ID. The unique research ID will be used for linkage. This spreadsheet containing patient identifiers, will be sent from each site to the Royal Free Hospital through secure encrypted NHS email.

The Royal Free Hospital will use the NHS Digital National Data Opt-Out extraction service to remove all cohort members who have registered a National Data Opt-Out.

2. Study data will be generated from medical records collecting baseline characteristics and investigations over a 10-year period.

3. The Royal Free Hospital will collate all separate cohorts together and send the complete cohort (approx. 2,900 records) to NHS Digital along with the Name, Date of Birth, NHS number and unique Study ID via the Secure Electronic File Transfer Service (SEFT).

4. NHS Digital will use the cohort identifiers and apply the National Opt Out preferences again to remove any cohort members who have opted out, and then link and extract all HES and Mortality data for the period April 2008 to March 2020.

5. NHS Digital will remove all identifiers (keeping the unique Study ID) and send the pseudonymised data extracts back to the Royal Free Hospital via SEFT.

The data will be returned to the Royal Free Hospital, without patient identifiers and with unique research ID alone. No identifiable fields have been requested from NHS Digital, to safeguard patient data. The data will be processed solely by the Royal Free Hospital by only substantive employees, who are bound by patient confidentially agreements. The record level pseudonymised data will be securely stored on Royal Free servers with password protection/restricted access drives. Statistical data analysis will be carried out via Trust owned remote devices connected to the Royal Free Hospital network either directly in person or remotely, using an appropriate statistical package. To remotely access the devices requires a secure 2-factor authenticator (VPN) and users are then able to securely access the secure server on the Trust’s IT framework. All data analysis will be conducted within the confines of the Trust’s secure server, and will not be downloaded to remote devices for storage or processing. There will be no linkage to data beyond that already described in this agreement. The original cohort identifiers (Patient Identifiable Data) is also stored separately and securely on Royal Free servers with password protection/restricted access drives.

The record level pseudonymised data will be interrogated to establish how many hospital attendances were required over a 10-year time scale. The data will also be further analysed to assess if these encounters were related, unrelated or possibly related to an underlying diagnosis of Pulmonary Hypertension. The data will remain pseudonymised using unique research IDs (Study ID) throughout this process to safeguard the subject’s identity. There will be no re-identification of the data subjects once the data has been collated.

The aggregated and suppressed data will be sent for analysis by a statistician who is a substantive employee of University College London. Only aggregated data and suppressed data (as per the HES analysis guide) will be sent onwards from the Royal Free Hospital. There will be no distribution of record level HES or mortality data, to mitigate the risk of re-identification of the patient. Aggregated and suppressed data files will be transferred via a secure and encrypted emailing system, using password protection.

The NHS Digital record-level data and original cohort identifiers will remain at the Royal Free Hospital, on an encrypted and password protected USB stick, for 5 years, in line with archiving practices for Research. Upon starting the archiving period, the USB will be issued to the Royal Free Hospital IT department who will store it securely at a secure off-site facility at Iron Mountain (UK) Limited together with the study documents. Only named members of the study team will have access to documents/USB archived off-site. The Royal Free Hospital will follow the guidelines of securely archiving the data as per this Data Sharing Agreement.

Iron Mountain (UK) Limited do not access data held under this agreement as they only supply the building and are therefore not listed as a Data Processor. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database containing the data.

HES and ECDS DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, data analysts must make sure that:
· National-level figures only may be presented unrounded, without small number suppression
· cell values from 1 to 7 (inclusive) are suppressed at a local level to prevent possible identification of individuals from small counts within the table.
· Zeros (0) do not need to be suppressed.
· All other counts will be rounded to the nearest 5.
Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

COVID-positive adults for FLARE trial — DARS-NIC-386685-K2B6G

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Statutory exemption to flow confidential data without consent)

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2021-01-14 — 2021-03-31 2021.01 — 2021.02.

Access method: One-Off

Data-controller type: ROYAL FREE LONDON NHS FOUNDATION TRUST, UNIVERSITY COLLEGE LONDON (UCL)

Sublicensing allowed: No

Datasets:

  1. Covid-19 UK Non-hospital Antigen Testing Results (pillar 2)
  2. COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2)

Objectives:

The purpose of this application is to identify individuals who have recently been diagnosed with COVID-19 via the national testing programme. These individuals will be telephoned by the trial team at the Royal Free London NHS Foundation Trust to tell them about the FLARE clinical trial and invite them to enrol. The aim is to make eligible subjects aware of the FLARE clinical trial and give them an opportunity to join a study testing treatments for COVID-19.

The FLARE trial is investigating two antiviral drugs (favipiravir and lopinavir/ritonavir) for early COVID-19 disease. Favipiravir has demonstrated good in vitro activity against SARS-CoV-2, the causative virus of COVID-19, and early clinical data have been encouraging. Lopinavir/ritonavir also has reasonable activity against the virus and may synergise with favipiravir so that the combination is particularly effective. By treating people with effective antivirals early in the disease, the aim is to interrupt viral replication thereby shortening the duration of symptoms and reducing risk of complications.

The study is a Phase II, randomised, double-blind, placebo-controlled trial with a factorial design. It will provide robust data on the effectiveness of the treatments on the level of the virus (viral load) in the participants’ saliva as well as data on safety and tolerability. Additional secondary end-points include the effect of therapy on duration of fever, hospitalisation, and the extent of mutation in the SARS-CoV-2 virus.

Further information about the FLARE clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT04499677

The trial is currently recruiting through hospital (A&E) attendees at Royal Free London and Occupational Health departments and has under 50 people recruited. Given that the trial aims to recruit 240 participants, and the recruitment period will end on 31st March 2021, use of the PiIlar 2 data to speed up the recruitment process is proposed.

The FLARE clinical trial’s use of the Pillar 2 data is permitted under Regulation 3(3) of COPI. The confidential patient information to be processed is required for a COVID-19 purpose and will be processed solely for that COVID-19 purpose in accordance with Regulation 7 of COPI.

By receiving lists of potentially eligible individuals from the Pillar 2 dataset who have recently been diagnosed with COVID-19, the trial team will be able to recruit willing individuals onto the FLARE trial, and at greater speed than previously, and therefore enable crucial research evaluating COVID-19 treatments. Recruitment onto FLARE is the only purpose for the trial team receiving this data and no more Pillar 2 data will be required after the target of 240 participants is reached.

The data subjects will be adults age 18-70 years, living in London, with a positive COVID-19 test in the last 7 days. By restricting the geographical spread of the data to London, the aim is that the majority of those contacted would be living in an area which is suitable for trial enrolment due to the location of the trial site, Royal Free London.

The minimum data required for making contact with potential trial participants is:

- Name of the subject: needed to identify that the trial team are speaking to the correct person on the phone.

- Telephone number: needed in order to contact the subjects.

- Postcode within London: needed to choose who to contact, as priority will be given to those individuals living close to the trial site (Royal Free Hospital).

Consideration has been given to whether the trial should be contacting individuals directly, and whether the recruitment could be managed through the Test and Trace service, i.e. the service are already set up to contact individuals and could inform them of the trial when they get in touch. However, given the use of contractors to operate this service, and thereby creating an extra layer to the process, this is unlikely to fit with the timescales the trial are working to.

The question of whether ‘cold calling’ is appropriate has been considered for this application, especially against alternatives such as SMS and emailing. As time is of the essence for recruitment into FLARE, telephone is the most efficient and quickest means to ensure direct contact with the individual, who can answer questions instantly over a call. This also ensures ‘human contact’, as opposed to SMS / emails, with trained and experienced research nurses working directly for the trial team providing that contact. During the calls, clear explanation will be given to individuals about how the trial has been able to contact them and what to do if they do not wish to be contacted again (i.e. registering a national opt-out). The trial team should apply the Telephone Preference Service when contacting individuals s as a proxy in the absence of a more sophisticated means of ascertaining people who might not want to be contacted by telephone. The trial team will also ensure any eligibility considerations are discussed early on in the calls so as to not to get the individual’s hopes up if they are not in fact eligible for the trial. Lessons have been learned from a recent NHS Digital request for contact details provided to researchers to contact people to donate blood and plasma, with careful attention paid to the various take up rates and any changes to these rates between the first and second waves of the pandemic. However, unlike that trial, FLARE could potentially be of direct benefit to the individual.

Other considerations that have been taken into account in relation to contacting individuals:

• The data relating to positive COVID19 tests is sent to NHS Digital at the same time that it is sent to the Business Services Authority, the latter process triggering the SMS to the individual informing them of their result. It then takes around four hours for the Pillar 2 dataset within NHS Digital to be updated with this information. Given that this information then needs to be extracted from the dataset at some point in the next 24 hours, then used by the trial team to make contact with the individual, the risk of the individual being informed of their test result by the trial team before they have read their SMS is small. However, the trial team should have a suitable script prepared to deal with this slim possibility.

• The chances of people having multiple positive COVID19 test results are rare, and rarer still is the likelihood that they will be one of the 300 people extracted from the thousands of daily test results to be sent to the trial team on more than one occasion. Therefore the risk of an individual being contacted twice for recruitment into FLARE is extremely low.

• NHS Digital recognises that there are likely to be more requests of this nature in future and therefore, if multiple trial require extracts of people to contact, suitable controls need to be in place within the extract process to ensure that individuals are not getting contacted for recruitment into trials more than is reasonably expected.

Expected Benefits:

As previously described, there will be no dissemination of the data from this application. However, the data will be used to invite subjects to enrol on the FLARE clinical trial. This trial will benefit health care by identifying effective antiviral treatments for COVID-19.

As previously described, there will be no dissemination of the data from this application. However, the global coronavirus pandemic is an unprecedented health crisis and to date there are no proven treatments for early COVID-19 disease. The data from this application will play a crucial role in finding individuals who are willing to take promising experimental treatments for COVID-19 and ultimately help to identify effective treatments.

As previously described, there will be no direct outputs from the data. However, the data will be used to invite subjects to enrol on the FLARE clinical trial. This trial will benefit health care by evaluating antiviral treatments for COVID-19 which are urgently needed.

Outputs:

The data will be used to identify individuals who are likely to be eligible to enrol in the FLARE clinical trial due to their recent positive COVID-19 swab, age and location. Their names and telephone numbers will be used in order to call them and invite them to enrol on the trial. If they consent to being enrolled on the trial, then all subsequent data will be collected as needed from the individuals directly with informed consent as per the study protocol and will be subject to the FLARE clinical trial approved procedures, privacy agreements, data agreements, etc.

As previously described, there will be no direct outputs from the data which is covered in this application. The data asked for will be used only to identify individuals to invite them to enrol in the FLARE clinical trial.

There will be no dissemination or communication of the data from this application. The FLARE clinical trial itself will generate outputs which will be communicated and disseminated; however, the data from this application is only going to be used to identify individuals so they can be invited to enrol on the clinical trial.

There are no outputs from the data itself. However, the FLARE clinical trial aims to complete enrolment by 31st March 2021 with outputs in the following months in 2021.

Processing:

There will be no flow of data into NHS Digital as part of this application. The data will be accessed by the FLARE clinical trial team in order to contact the data subjects and will not be used beyond this. The data will be processed at the Royal Free Hospital and not passed on beyond the FLARE clinical trial team.

The location, name and telephone number of the data subjects will be used to contact them and invite them to join the clinical trial. This is the sole use of the data. The data will not be linked to any other data. The data will be accessed on NHS computers on the Royal Free network which is a secure environment.

A detailed breakdown of the data processing is as follows:

• Twice a week, and for a two week period, NHS Digital will interrogate the Pillar 2 dataset and extract 300 individuals at random who are aged between 18 and 70 years, live in certain postcode areas of London, and who have received a positive COVID 19 test result in the previous 24 hours. If less than 300 records are extracted, all of these will be provided.

• The individuals will be resident in England-only as determined by the postcodes of residence.

• Filters will be applied to remove patients who have registered a national opt-out, as well as special categories of people for whom the data should not be disseminated, such as prisoners.

• Individuals who have signed up for the Telephone Preference Service will need to be taken into account.

• The flow from NHS Digital to the trial team will be via a SEFT account.

• The trial team will use the data provided to make outbound telephone calls to ask if the individuals would be interested in being recruited into the trial.

• The aim is to contact 300 people following each drop of data and recruit as many as possible into the trial.

• The number of individual contact details supplied by NHS Digital to the trial team in each drop may be reviewed once the take-up rate is better understood.

• Additionally, the original two week time period, plus the number of extracts / dops per week may be reviewed and amended once the take-up rate is better understood.

• The trial team will hold the data securely adhering to all IG Policies in the Dept., the team will call the data subjects to inform them of the trial, screen, consent and randomise them.

• The identifiable data received from NHS Digital will be deleted on a weekly basis as the trial team will no longer require it.

Royal Free London NHS Foundation Trust and University College London are joint Data Controllers for the data, with Royal Free London NHS Foundation Trust also acting as the sole Data Processor. Although University College London have delegated responsibility for recruitment to the Royal Free London NHS Foundation Trust, they retain responsibilities for the way in which the trial is run and the trial documentation and therefore have overall responsibilities as a Data Controller.

No other bodies or organisations (including other bases within Royal Free London) need to be included as Data Controllers or Data Processors in this agreement.

LifeArc are the charity funder of the FLARE trial. Note that the funder will not have influence on the design or outcomes of the trial, nor suppress any of the findings of the research.

MR901 - MORTALITY IN BARRETT'S OESOPHAGUS PATIENTS — DARS-NIC-148034-SCKLL

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2018-10-01 — 2020-09-30 2018.03 — 2020.03.

Access method: Ongoing, One-Off

Data-controller type: ROYAL FREE LONDON NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report

Objectives:

The data supplied to the Royal Free Hospital will be used only for the approved medical research project - MR901 - MORTALITY IN BARRETT'S OESOPHAGUS PATIENTS

Yielded Benefits:

An initial analysis of mortality in patients with Barrett's oesophagus was done and published in 2012. This showed that patients with Barrett's had a greater mortality from oesophageal adenocarcinoma than the general population but not from any other cause of death. It is important to repeat the analysis with greater numbers, over a longer time period and a greater geographical area. The information that patients suffering from Barrett's oesophagus have a greater mortality from oesophageal adenocarcinoma but no other cause of death. This work has been cited many times since publication, providing a strong evidence base for other research and management of Barrett's patients. If either confirmed or refuted the information will have a big impact on the type of care given to Barrett's oesophagus sufferer as they will not need to have screening or surveillance for any other cause of either mortality or morbidity.

Expected Benefits:

It is important to reanalyse the data with much larger numbers and at least one other centre, in order to confirm the findings and establish that this is not a phenomenon confined to Rotherham.
The results would impact the management of Barrett's oesophagus patients. They have already influenced British Society Guidelines and some clinicians have made individual changes to their practice. Long term the risk of BO patients progressing to oesophageal adenocarcinoma will be reduced resulting in both lives being saved and the cost to the NHS being reduced.
There is no final target date but 2 years in the first instance.

Outputs:

A study using causes of mortality in Barrett's patients compared to the general population was accepted for oral presentation at a conference in the USA and the abstract published in Gastroenterology in 2010. A full paper was published in Endoscopy in 2012 . The UKBOR hope to repeat this with information from additional death certificates. These results will be invaluable for strategies on the management of patients with Barrett's oesophagus and for strategies to prevent progression to cancer. If confirmed by a larger and geographically more extensive study clinicians could be confident that the increased mortality in BO patients was only from oesophageal adenocarcinoma. The results have been used in the British Society of Gastroenterology Guidelines for the diagnosis and management of BO, and by gastroenterology clinicians, surgeons and nurses. These are research results for use by medical personnel and not patient friendly. However the publications list is freely available on the BOUK website, the charity that funds UKBOR.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Patient identifiers (NHS number, study ID, name, gender, date of birth and address) were sent to the predecessor bodies (NHS Information Centre and the General Register Office) for linkage. Death details for any patient who had died was sent on a yearly basis in March and was recorded in the appropriate fields on the UKBOR database held at the Royal Free Hospital. In the future this information will be analysed, either as a cohort or case control studies, in line with the objectives above. Identifiers are removed during the course of the analysis and no one can be identified from the outputs published. For this agreement, the cohort is already flagged by NHS Digital, so no identifiers will flow into NHS DIgital.

The data will not be linked with any record level data other than the UKBOR data referred to above.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

Amendment to MR479a - Survival in Amyloidosis — DARS-NIC-147841-1G36R

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Y, Identifiable, Yes, No

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, , Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (NHS Trust)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2011-02-07 — 2026-02-06 2016.04 — 2018.05.

Access method: Ongoing

Data-controller type: UNIVERSITY COLLEGE LONDON (UCL)

Sublicensing allowed: No

Datasets:

  1. MRIS - Scottish NHS / Registration
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report
  6. MRIS - Personal Demographics Service

Objectives:

Are to arrive at conclusions regarding prognosis of Amyloidosis, its natural history and the effects of Radioisotope Scanning treatment.

Yielded Benefits: