NHS Digital Data Release Register - reformatted

University Of Glasgow projects

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

Application for Adult Psychiatric Morbidity Survey 2014 — DARS-NIC-252902-C7C6P

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2019-06-20 — 2022-06-19

Access method: One-Off

Data-controller type: UNIVERSITY OF GLASGOW

Sublicensing allowed: No

Datasets:

  1. Adult Psychiatric Morbidity Survey
  2. Adult Psychiatric Morbidity Survey (APMS)

Objectives:

Despite the fact that suicide deaths are most often among men, especially among those who are most disadvantaged, relatively little research has focused specifically on men. Guided by the Integrated Motivational-Volitional (IMV) model, this project aims to use the Adult Psychiatric Morbidity Survey (APMS) database to enhance understanding of various aspects of men and women’s lives who experience suicidal thoughts and behaviour, such as socio-demographics and social support, which can guide prevention and intervention services. This project is part of a PhD “Towards an enhanced understanding of suicide risk in men”. The project will involve both quantitative and qualitative methods.

The University of Glasgow is the sole data controller with sole autonomy for determining the purposes for processing the APMS data and the manner of processing. The data will only be processed by the applicant who is a substantive employee of the University of Glasgow. No other organisation will process the data.

The lawful basis for processing is for research and public interest purposes. The processing will achieve the purpose of gaining an insight into the male experience of suicide. This research is in the public interest as it will provide an insight into the lives of people who have experienced suicidal thoughts and behaviours. It will provide potential areas for intervention and prevention efforts and will help to identify those at risk of attempting to take their own life.

The processing of this data has substantial public interest as it involves the use of a large general population survey, for which participants have consented to their data being used for mental health research. The rights and interests of the participants is safeguarded as this is a pseudonymised data-set and the participants were made aware that their data will be accessed by researchers and published (anonymously) in research publications.

The University of Glasgow does not foresee any potential moral or ethical issues to arise through the dissemination of this data, as the participants in this data-set have consented to their data being used for research purposes, their data is pseudonymised, and the data has already been collected. Ethics approval is not required for secondary analysis of pseudonymised epidemiological datasets.

The Adult Psychiatric Morbidity Survey (APMS) series provides data on the prevalence of both treated and untreated psychiatric disorder in the English adult population (aged 16 and over).
The overall aim of the present study, therefore, is to investigate the association between target variables and suicidal thinking and behaviours in men. There are two specific research questions: 1) What are the predisposing factors linked to suicide in men? 2) What are the differences between risk factors for suicidal thinking and behaviour in males and females?

The data will allow the researcher to investigate the risk factors for suicidal thoughts and behaviours in a large general population sample of adults. The data will be used for a research paper (or papers) investigating risk factors for suicide in men. Gender differences may also be investigated.

The Data Controller has not identified any alternative, less intrusive ways of achieving the purpose. The APMS dataset is already pseudonymised and therefore the level of data cannot be further minimised.

Expected Benefits:

Target Date – 2021. This study will provide an enhanced understanding of suicide risk in men, by analysing the gender differences in a variety of factors such as help seeking and will provide key targets for health and social care services. This will aid services to better recognise and respond to men with suicidal ideation, in time helping to reduce the number of men in a suicidal crisis. This can also improve patient experience at a time when they are vulnerable as services are more equipped to identify and address issues that patients may be presenting with. This study will also provide further evidence in relation to the use of the Integrated Motivational Volitional (IMV) Model (O’Connor & Kirtley, 2018) of suicide in relation to male suicidal thoughts and behaviours.

Outputs:

All outputs will only contain data that is aggregated in line with NHS Digital guidelines.

This data will be used in at least one scientific research paper that will be prepared for publication in a peer-reviewed journal, such as The Lancet Psychiatry, and will be included in a PhD project. The target date for this is 2021.
The data presented in scientific research publications will be summary (aggregate) data.

The data will be disseminated via peer-reviewed journals, mental health blogs and academic conferences.

In order to protect patient confidentiality in publications resulting from analysis of APMS data users must:
• guarantee that any outputs made available to anyone other than those with whom this agreement is made, will meet required standards, including the guarantee, methods and standards contained in the Code of Practice for Official Statistics and the ONS Statistical Disclosure Control for tables produced from surveys;
• apply methods and standards specified in the Microdata Handling and Security Guide to Good Practice for disclosure control for statistical outputs.

Data linkage request for 'Effectiveness of Intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)' — DARS-NIC-433923-Z0V8D

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: Yes (Academic)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2022-02-01 — 2025-01-31 2022.03 — 2023.12.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF GLASGOW

Sublicensing allowed: No

Datasets:

  1. Cancer Registration Data
  2. Civil Registration - Deaths
  3. Hospital Episode Statistics Admitted Patient Care
  4. Civil Registrations of Death
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

IRONMAN (Effectiveness of IntRavenous irON treatMent vs standard care in pAtieNts with heart failure and iron deficiency) is a randomised trial of Intravenous (IV) iron involving 1400 study participants with heart failure and iron deficiency in England and Wales, powered to detect effects on morbidity, mortality and cost-effectiveness that will inform clinical management and international guidelines. The Trial is being run by researchers in the Robertson Centre for Biostatistics (RCB) at the University of Glasgow

The trial will look at whether there is evidence that the addition of IV iron to standard care is of benefit. It is an investigator-designed and initiated study. It will utilise a PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) design. That is, the participants will be randomised to normal care or intravenous iron therapy with the participants and their physicians being aware of the treatment received. The study outcomes will be reviewed and adjudicated by an expert group who have no access to the randomisation arm the participants have been allocated to. Participants will be assigned to receive IV iron or not, in addition to guideline-indicated care. Participants assigned to IV iron will receive repeated doses sufficient to ensure iron repletion for the duration of the study. For participants consenting to collection of blood samples, samples will be stored for a biobank sub-study involving future analysis of biomarkers related to the progression of heart failure and patient outcomes. It is an event-driven trial, but it is expected that participants will be treated for between six months and 5.5 years. The study commenced in 2016 and is ongoing. Recruitment completed in October 2021 and the study follow up is expected to complete in March 2022. Long-term follow up will be for up to 10 years after recruitment ended.

Hospital Episode Statistics (HES) data will not include data for those treated at Welsh hospitals.

There was Public and Patient Involvement (PPI) in the trial design; the West Middlesex patient cardiomyopathy support group provided input and the draft protocol was reviewed by an independent heart failure service (Gloucestershire – heart failure nurse specialists and patients, coordinated by Head of Specialist Services). Full endorsement was given to the need for the study. There is also a patient representative on the Trial Steering Committee (TSC).

The pseudonymised record-level data requested from NHS Digital will allow the study researchers to obtain events (hospitalisations, cancers and deaths) in the year prior to the study participant's consent date, during study participation and up to ten years after the study end. As this is a morbidity/mortality study, follow up for clinical events is critical.

The University of Glasgow relies on the following Articles for General Data Protection Regulations (GDPR) lawful basis for data processing. Article 6(1)(e) (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller)– The University of Glasgow are under a Royal Charter and NHS Digital are satisfied that this request is appropriate, necessary and proportionate for the performance of the task described herein and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.
Additionally, as health data is a special category of personal data, Article 9(2)(j) (archiving in the public interest, scientific or historical research or statistical purposes). The data is required for research purposes meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The Data Protection Act 2018 Schedule 1 Part 1 states that when processing special category data under the condition relating to research, the condition is met when:
(a) 'necessary for archiving purposes, scientific or historical research purposes or statistical purposes'. As described above the data is considered necessary for the performance of the task
(b) 'carried out in accordance with Article 89(1) of the GDPR'. In accordance with this article, processing is subject to appropriate safeguards. These include:
i. The data will be pseudonymised prior to dissemination by NHS Digital to the data recipient;
ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS Digital’s acceptance criteria (see sections 2 and 5b of this application for further details);
iii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details);
iv. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection (see sections 5a, 5b and 8a of this application for further details);
(c) 'is in the public interest'. NHS Digital is content that the information set out in the Benefits section of the application evidences that the data processing will be in the public interest - This study could result in a change to treatment guidelines in the way patients with heart failure are treated – therefore demonstrating that the processing is in the public interest. Data linkage will provide a more complete and objective record of study events than is otherwise available from local records.

The requested data are record level pseudonymised Cancer Registration data, Civil Registration (Deaths) data, and Hospital Episode Statistics (HES) – Admitted Patient Care (APC).

In terms of data minimisation, the study team are only requesting NHS Digital data necessary to detect study serious adverse events, potential endpoints and primary and secondary outcomes linked to 1,400 IRONMAN consented patients from one year prior to date of consent and up to ten years after study end. Clinical trials are required to collect data on Serious Adverse Events that include hospital admissions, deaths, and cancers.

The project has minimised the data requested for the consented population to those data elements needed to address the research questions and only access to pseudonymised data for up to one year prior to consent is requested. The study team have limited the fields to only those requested to fulfil the study analysis. Pseudonymised record-level patient data will be held on the Robertson Centre for Biostatistics (RCB) Analytical Platform. More information on this platform can be found in section 5(b) below. The study researchers, who are substantive employees of the University of Glasgow, will link the NHS Digital record-level pseudonymised data to the data collected in the IRONMAN study using a numerical study pseudo-identifier only to study concordance of the different sources of information. There are no other ways to obtain these data.

The only record-level identifiable data linkage permitted under this agreement is the linkage of the cohort identifiers provided to NHS Digital by University of Glasgow (IRONMAN ID number, NHS number, date of birth, postcode and name) to the NHS Digital data sets requested in this agreement expressly for means of extraction. Pseudonymised record-level data will only be accessed by substantive employees of the University of Glasgow, and will not be shared with any organisation, including funding organisations.

University of Glasgow is the Data Controller who also processes data for the purposes of this agreement.

This study is funded by the British Heart Foundation with support from Pharmacosmos in terms of the investigational medicinal product (IMP)who also provide additional financial support. Neither the British Heart Foundation nor Pharmacosmos have a designated role or responsibility in trial design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results. Neither the British Heart Foundation nor Pharmacosmos will have access to record-level data from NHS Digital. As a result, neither organisation are considered a Data Controller or Data Processor. A representative from Pharmacosmos will be invited to attend Trial Steering Committee (TSC) meetings as an observer and non-voting member. All members of the TSC are allowed to speak at meetings and as Pharmacosmos provide the drug for this study and distribute to the study sites, their input into study drug supply and distribution is invaluable. Pharmacosmos have no influence in the design or conduct of the study. Support from Pharmacosmos will be acknowledged in any publications related to the study.

NHS Digital is content that the purpose of this study is to assess whether the addition of IV iron to guideline-indicated therapy for Chronic Heart Failure (CHF) reduces morbidity and mortality in patients with iron deficiency and is cost-effective, 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 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. If the study provides clear evidence of benefit of IV Iron treatment for heart failure patients then the results of the study may be submitted by the University of Glasgow to the regulators of drugs in the UK, European Union and elsewhere. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.

Expected Benefits:

The IRONMAN study team aim to assess whether the addition of IV iron to guideline-indicated therapy for Chronic Heart Failure (CHF) reduces morbidity and mortality in patients with iron deficiency and is cost-effective.

Patients with heart failure often have reduced quality of life due to symptoms. The diagnoses also causes a significant psychological impact on patients due to concerns about mortality and impairment of lifestyle. An intervention, such as that is the IRONMAN study, that could be given as standard care on the NHS and could improve symptoms, functional capacity and quality of life would be of great benefit to patients.

All evidence resulting from the trial will be made available as required to regulators of drugs in the UK, European Union and elsewhere. If the study does provide clear evidence of benefit of IV iron treatment, a full submission of the results of the study to regulators could result in a change of labelling for the use of IV iron in the treatment of heart failure patients. Likewise, if the study raises any significant safety concerns this could also lead to changes in treatment guidelines.

The study team believes that it is very important that they capture all deaths, hospitalisations and cancers, and the NHS Digital record-level pseudonymised data requested in the agreement will help them to achieve this objective.

Outputs:

All Outputs including data will be aggregated with small number suppressed as per the HES analysis guide.
Results are expected to be reported in a peer-reviewed journal and at major scientific and clinical meetings. This is expected in 2022.

The research team believe that the results of this study would be of interest to a high impact factor journal. The research team intend to organise press releases to coincide with the publication to promote knowledge mobilisation of the study results. The findings are expected to be presented at major cardiovascular scientific and clinical meetings (e.g. European Society of Cardiology or American Heart Association meetings.)

The research team intend to produce a non-technical summary of the results which will be sent to patients who participated in the trial, patient groups and cardiovascular charities. The University of Glasgow aims to release a press release in collaboration with the British Heart Foundation. The research team will also work to generate media coverage of the study results (in aggregated with small numbers suppressed format) and communicate these to the wider public. Target date 2022.

Outputs may also be shared with funders, but ownership and control of the outputs rests with the University of Glasgow.

All evidence resulting from the trial will be made available as required to regulators of drugs in the UK, European Union and elsewhere. If the study does provide clear evidence of benefit of IV iron treatment, a full submission of the results of the study to regulators could result in a change of labelling for the use of IV iron in the treatment of heart failure patients. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.

Processing:

Data will be held and processed only by the study researchers, who are substantive employees of the University of Glasgow, who have been appropriately trained in data protection and confidentiality. Processing of data linkage data will be carried out on University-owned devices within the Robertson Centre for Biostatistics (RCB) secured office space or via remote access to these devices via Virtual Private Network (VPN). VPN access for RCB staff will be via authorised University-owned laptops or computers. Any data outputs shared outside of the University of Glasgow will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Summary reports of serious adverse events are made to the Medicines and Healthcare products Regulatory Agency (MHRA) in line with clinical trials requirements. Any suspected unexpected serious adverse reaction reports will be at a patient level. These reports will be based on information obtained from the hospitals participating in the trial and entered into the study electronic Case Report Form. No records obtained from NHS Digital will be shared with regulatory agencies.

The Robertson Centre for Biostatistics (part of the University of Glasgow) will provide:
- Data management (including electronic Case Report Form design, database setup and management, data validation)
- Statistical analysis and reporting (final report, Independent Data Monitoring Committee reports)
- Data management and statistical support to record linkage
- Provision of support for issues relating to data quality and use of endpoint adjudication system
- Project Management and Quality Assurance
- Transfer of patient identifiers to NHS Digital and receipt of record-level pseudonymised data from NHS Digital

Record-linkage for events will be carried out. For any events that appear not to have been previously reported, study sites will be asked to investigate and to report details of previously unreported events in the electronic Case Report Form. To do this, the study team will share record-level data with the study sites purely for the purpose of data completion. For hospitalisations, the study team will provide the study site with date of hospitalisation and the hospital which the participant was admitted to. For deaths, the study team will provide the study sites with date of death and location of death (hospital to be specified or out of hospital). Based on information obtained from the sites, clinical events that constitute important endpoints in the trial will be adjudicated by an endpoint committee without knowledge of the treatment group to which patients were allocated.

Data analysis will be carried out according to a pre-specified plan which will be completed and signed off before the study database is finalised.

METHODOLOGY
1. The Robertson Centre will provide NHS Digital with the following identifiable data for the 1,400 consented study participants: NHS Number, name, postcode, date of birth, consent date (which will be either date of consent OR date of consent minus 12 months, if the participant has consented to this) individual study ID and end date (which will be either date of extract or date of withdrawal, where applicable) via NHS Digital’s Secure Electronic File Transfer Service (SEFT).
2. NHS Digital will link and extract the requested data and return the pseudonymised data files with the study ID only to the University of Glasgow via SEFT.
3. The data will be downloaded from SEFT to, and processed via, the Robertson Centre Safe Haven at the University of Glasgow, within a secure network. Summary reports will be prepared and any additional information from the study database will be included (i.e. adjacent events already reported via the study web portal) with linkage occurring only using the pseudonymised study ID. Clinically qualified study staff will review the reports, via the Robertson Centre analytical environment (this is a secure, partitioned area within the Safe Haven), and mark up to indicate any events that should be followed up.

Analyses based on data linkages carried out after the end of trial follow up will be performed in a separate secure database containing record linkage data and data from the trial database. These analyses will take place within the Robertson Centre’s secured work environment. All outputs from these analyses will be subject to disclosure control. No record-level NHS Digital data will be forwarded to regulatory authorities. Identifiable record-level data is kept in a separate secure section of the Robertson Centre’s secured work environment to the pseudonymised NHS Digital record-level data.

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).

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 processors 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 sub-national 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.

Data linkage request for FAMOUS-NSTEMI study — DARS-NIC-170589-L2W0Y

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(5)(d)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2022-11-11 — 2025-11-10 2023.02 — 2023.02.

Access method: One-Off

Data-controller type: UNIVERSITY OF GLASGOW

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Hospital Episode Statistics Admitted Patient Care
  3. Civil Registrations of Death
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)

Outputs:

Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide. The outputs will be in the form of research reports and analytical outputs. The raw data (NHS Digital output) will be retained within the Robertson Centre for Biostatistics.

The University of Glasgow intend to produce manuscript drafts within 3 months of NHS Digital providing the data. It is anticipated that the manuscripts will be publicly available 6 – 9 months from the date provided by NHS Digital. Clinicians, the public, and academics will have access to the outputs in the form of Plain English summaries and peer-reviewed scientific papers submitted to reputable journals. The reports will be made ‘Open Access’ so freely available at no cost.

The publication of the results of this analysis are intended to be made available to the National Institute for Clinical Excellence (NICE). Since NICE provide clinical guidelines and updates for the management of patients with acute myocardial infarction, the University of Glasgow believe the results will be relevant to NICE and the NHS. It is intended that the results will also be highlighted to guideline committees of international societies e.g. European Society of Cardiology.

It is anticipated the results will be published in a high impact cardiology journal e.g. European Heart Journal, impact factor 23. There is also intended to be a paper published in a top health economics journal e.g. Value In Health, impact factor 5.9. The aim is to produce these outputs as soon as possible following data receipt.

There will be a report back to the funder (British Heart Foundation) (this will be the final report at the end of the project grant), but ownership and control of the outputs rests with the University of Glasgow.

Processing:

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 with the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data). Individual patient data will not be published or shared with a third party.

The Robertson Centre for Biostatistics (RCB) at the University of Glasgow will securely transfer a file of the following identifiers to NHS Digital for the trial participants recruited across the four English hospital sites.:
1. NHS number,
2. Full name,
3. Date of birth
4. Postcode
5. Unique study ID

NHS Digital will return the linked Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Mortality data including the unique study ID and no other identifiers.

The RCB at the University of Glasgow will store the data on a server in the RCB. Researchers can remotely access the pseudonymised data via Virtual Private Network (VPN) having gone through an internal approval process to gain VPN access. Removal of any data is technically prevented. Data will be controlled by using password encoded files and computers. The RCB has ISO 27001 standard data management processes. Data will only be held and processed by the University of Glasgow. Data will only be accessed by individuals who have authorisation to access the data for the purpose described, all of whom are substantive employees of the University of Glasgow and have been trained in data protection and confidentiality. Any data shared outside of the University of Glasgow will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The pseudonymised data is stored in a separate location to the participant identifiers. All personal details are kept in a separate more restricted database and only visible to appropriately approved study team members. The two datasets will not be re-linked and the data will remain pseudonymised. Access to patient identifiers is limited to a small number of named individuals to allow the cohort file to be sent to NHS Digital. Staff with access to patient identifiers are not involved in the analysis of the data. The data linkage file preparation is documented by the RCB staff members carrying out the process and this work is carried out in restricted file store and database areas.

The data will be accessed via the Robertson Centre Safe Haven at the University of Glasgow, within a secure network. Summary reports will be prepared and any additional information from the study database will be included i.e., adjacent events already reported via the study web portal. Clinically qualified study staff will review the reports, via the Robertson Centre analytical environment. Only statisticians will see the data and since the data are deidentified there will be no possibility of identifying any of the participants. Staff members within RCB will have access to the patient identifiable data to perform the data linkage preparation work but this access can be revoked once the work is finalised.

The returned record linkage datasets will be able to be analysed alongside the other study data by joining on the unique study ID (the pseudonymised ID). Outputs from these joins will not be presented at record-level outside of the permitted staff group within the University of Glasgow. Record-level data will only be accessed by the University of Glasgow, and will not be shared with any organisation, including funding organisations. All of this work will be conducted in the UK.

The epidemiology of peripartum cardiomyopathy in the United Kingdom. — DARS-NIC-262206-F1P5Z

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Academic)

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

When:DSA runs 2020-06-08 — 2023-06-07 2020.10 — 2020.10.

Access method: One-Off

Data-controller type: UNIVERSITY OF GLASGOW

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Hospital Episode Statistics Admitted Patient Care
  3. HES:Civil Registration (Deaths) bridge
  4. Civil Registration (Deaths) - Secondary Care Cut
  5. Civil Registrations of Death - Secondary Care Cut
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

The University of Glasgow is the data controller for a study for which the aim is to collect data on a rare pregnancy-related type of heart failure, Peripartum cardiomyopathy (PPCM) and describe the epidemiology of the condition in the UK. At present, it is understood that there are no studies of this condition from the UK and only two from Europe and there remain many unanswered questions about the condition.

The data requested will allow researchers to answer many important questions about the pattern of Peripartum cardiomyopathy (PPCM) in the UK. At present, there is no UK-based information to give to women with the condition or to guide decision-making with regards to their management and future pregnancy risk. Extrapolating information from studies from other countries can be difficult as the population demographics often differ markedly. For example, many studies are from South Africa, but in predominantly black women whose outcomes differ from women of other ethnicities. As the population in the UK is predominantly Caucasian, applying evidence from South Africa to women in the UK is difficult.

The study will form part of a programme of research into the epidemiology of PPCM in the UK. It will take the form of a retrospective cohort study with a nested case-control study. The same study is also taking place in Scotland using similar routinely collected NHS hospitalisation data collated and linked by NHS National Services Scotland. It will collectively form the basis of PhD project for an individual at the University of Glasgow.

The data subjects are all individuals who had an obstetric episode between 1997 to 2017 plus one of seven specific ICD diagnostic codes which indicate PPCM, heart failure (HF), hypertensive heart disease (HHD) or cardiomyopathy (CM), within 9 months prior and up to 2 years after the obstetric episode.

The data requested comprises hospitalisations for a limited number of specified health conditions/procedures related to the heart and to other comorbidities of interest to the study (e.g. diabetes, cancer, respiratory diseases, anaemia, etc.), maternity records and linkage with death records. This will allow an individual to be tracked to the end of life in order to report repeat hospitalisations and mortality.

The maternity records contain some information about the infants who are additional data subjects. This information will be used to assess the viability of analysing infant/child mortality and maternal outcomes and to undertake analyses if feasible.

For the comorbidities of interest, the data requested is limited to:
- Date of admission
- Date of discharge
- Length of stay
- Age at time of admission
- Diagnostic and procedural codes
- Deprivation marker
- Ethnicity

Ethnicity as a variable is relevant because it may be associated with both developing the condition and with outcomes after diagnosis. For example, Black race has been shown to increase the risk of developing PPCM by 16-fold. The study would investigate whether ethnicity is a risk factor in the UK, if the data contains sufficient numbers to be able to do so.

The data are pseudonymised to protect patient confidentiality. It will not be possible for the researchers to identify individuals from the data and no attempt will be made to identify individuals.

A period of 20 years is being requested; given that the condition is rare (the incidence in the only population level study from Europe was 1 in 10,500 live births) researchers believe that by expanding the study period to this extensive period will increase the study sample and ensure the statistical techniques employed are as robust as possible. The data controller request data for the whole of England to ensure this is a population-level study. This is important for two reasons:
1) currently only one population-level study in Europe exists but this is small (n=61 women)
2) this will allow researchers to report on an unselected cohort of women and reduce the bias associated with selecting certain geographical areas only. For example, some areas may have a specialist heart hospital or have a clinician with a specialist interest in the condition which could therefore artificially inflate the incidence of the condition.

Only data required to achieve the desired outcomes are being requested.

Only aggregate data (with small numbers suppressed) will be published.

In a subsequent Agreement, the researchers will request data for a control group. The control group will be required for a sub-set of the cohort provided under this Agreement i.e. women with ICD10 codes of PPCM, HF and CM (plus maternity). Researchers plan to request matched controls for this subset, which will be matched for age, health board/trust, and year of delivery. These matched controls will be requested at a later date and the University of Glasgow will submit a formal request to amend this Agreement when ready to request the control data.

Routinely collected HES data will be used, and therefore there is no direct relationship with patients. The way in which researchers process the personal data will be fully compliant with GDPR; the processing will be carried out using the following lawful basis:
Article 6(1)(e) Public Task: “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”

As Special categories of personal data is being processed, the following lawful basis will also apply:
Article 9(2)(i)Public Interest: “processing is necessary for reasons of public interest in the area of public health'.

The data controller believes that the outcome of this research will be of great public interest both nationally and internationally.

The organisations involved in this project and their roles are as follows:

The British Heart Foundation (BHF) has funded a BHF Clinical Research Training Fellowship for an individual studying for a PhD with the University of Glasgow. This project will form the basis of that PhD. The BHF has not been involved in the design of the study, makes no decisions in relation to the processing of any data under this Data Sharing Agreement and will not access any of the data under this Agreement.

The University of Glasgow is the sole data controller. The University of Glasgow employs the Chief Investigator/Study Statistician and the two co-investigators – one of which is the PhD student referred to above. These individuals designed the study and make all decisions regarding how and why the data under this Agreement are processed.

NHS Greater Glasgow and Clyde was named as the study Sponsor in the study Protocol v2.0. The decision to name this organisation as a Sponsor was taken because, for the element of the study population based in Scotland, the University of Glasgow chose to undertake a sub-study which involved validating the cases and collecting more data directly from patient records at NHS sites. This would be done through the NHS and these data would be held on an NHS platform. For this reason, NHS GGC was added as the sponsor for this aspect of the study. NHS GGC has no involvement with the element of the study which involves the collection and processing of NHS Digital data under this Agreement. For clarity, NHS GGC has had no input into the decisions how or why to process this data and will not access this data.

The study Protocol v2.0 also named West Glasgow Ambulatory Care as the location of the Sponsor Representative. Again, this is only relevant to the data being collected in Scotland and has no relevance to the data under this Agreement.

The University of Glasgow will be the sole processor of the data. The processing will not involve any other data processors as all of the processing will be undertaken by the University’s Research Team in-house. The Research Team carrying out the processing has the required extensive experience to undertake the processing activities required for the research task(s). The Research Team will monitor the processing of the data in line with the relevant data protection laws and regulations as advised by the University’s Data Protection & FOI Office. The data controller's DPIA will also continue to be reviewed by both the Research Team and the Data Protection & FOI Office to ensure that it is updated if and when necessary to include changes in legislation and/or GDPR. The Research Team have also consulted with the University’s Information Technology team’s ‘Information Security Policies’ to ensure that data is processed in line with their recommendations.

Expected Benefits:

There are currently no data on the epidemiology of PPCM from the UK and only 2 studies (small case series of fewer than 10 patients also exist) of patients from Europe with the condition. Extrapolating data from other countries has been difficult for two main reasons. Firstly, there is wide geographical variation in the reported incidence, prevalence and survival and, secondly, there are few studies with longer follow-up or data on outcomes of children born to women with PPCM. The data will therefore be of direct relevance to the health and social care system in the UK and will add to the global picture of PPCM from which the UK is currently missing and European data are sparsely represented. The project will fill this knowledge gap. It will allow a range of health care professionals to provide real-world evidence to patients, to better inform women about their condition, to more effectively communicate risk (including risk surrounding a future pregnancy), and to answer questions about potential dangers to the new born babies. Most importantly, it will help to better identify those at risk of developing the condition and highlight those with a high likelihood of an adverse outcome; it is these women that can then be targeted with tailored interventions in order to try and reduce the occurrence of the condition and improve prognosis for those in whom it is established.

There may also be a benefit to service delivery in Scotland; through a better understanding of the risks associated with PPCM, services can be redesigned to account for this risk, such as tailoring the level of monitoring for women with prior PPCM depending on the absolute level of risk researchers find in the population. This may involve a re-organisation of services into regional or supra-regional centres or may lead to an increase in local services if the risks are low enough to be managed in this setting.

The findings will be of value to a wide range of clinical researchers, from cardiologists to obstetricians, paediatricians and specialist heart failure nurses. This may allow the development of new avenues of research into the disease by identifying associations with incidence and outcomes and may elucidate new treatment pathways for the condition. The findings will also be of interest to basic science researchers, who can use newly identified associations to guide basic research into the mechanisms behind PPCM. By producing accurate, contemporary numbers on the incidence and survival of patients and their children, the work will inform future power calculations for trials of therapies in PPCM. At present, the widely varying estimates in the literature and lack of European data have made this a difficult task for those undertaking clinical trials in this area.

The research team will devise a patient-leaflet explaining relevant findings in user-friendly terminology to provide information to patients and their families. The co-investigator is involved in work at the Global Jubilee National Hospital, a specialist heart hospital in Glasgow and also has a role in the charity Pumping Marvellous. Therefore the team will be able to provide information directly to patients affected by PPCM. Results will also be disseminated via national and international academic meetings, such as the British Cardiovascular Society and European Society of Cardiology (ESC) congresses. In addition, results will be disseminated within the network of specialists involved in the ESC Study Group on PPCM (via co-investigators who are official members) and to the academic community by preparing the work for publication in high-impact journals. It is therefore likely that the study will also inform future position statements and guideline-recommendations from the European Society of Cardiology PPCM Study Group.

Outputs:

Results of the stated analyses will be disseminated through the following means:
- Submission to peer-reviewed medical journals for publication
- Presentation (oral and poster) at scientific conferences and seminars (obstetric and cardiology)
- Dissemination of information to patient groups (such as our focus group) and generation of patient-information leaflets to de distributed to e.g. cardiac/obstetric centres, specialist nurses, patient support groups
- Inform Position Statements from the European Society of Cardiology PPCM Working Group
- To form part of a PhD undertaken by Dr Jackson

Through these means the following groups of people will have access to the published study results:
Academics, clinicians, patients/public, policy-makers/managers.
The outputs will not be used for commercial purposes, not provided in record level form to any third party and not used for direct marketing.

All outputs will only contain results in highly aggregated format and as statistical summaries and measures of association. Small numbers will be suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party. Where outputs include abortion episodes, all national figures will be suppressed if less than 8. For sensitive ages (<15) figures will be suppressed if less than 10.

Time frame (from receipt of data):
0-12 months: Cleaning of data and analysis
12-24 months: Generation of abstracts and manuscripts for submission to journals and conferences
24-36 months: Writing up of PhD

Processing:

Patients with an incident discharge diagnosis of PPCM will be identified using the relevant ICD codes. Cases from 1997-2017 will be identified. This time frame will allow researchers to provide a minimum of 10-year follow-up for women earlier in the cohort (and reporting long-term outcomes is one of the research aims) as well as increasing the number of cases in the study. Given the anticipated rarity of the condition (there are no published data on the incidence in the UK but, from an unpublished pilot study in Scotland conducted by the research team, the incidence was reported as 1 in 11,000 live births), using all the available data will allow researchers to most accurately report the epidemiology of this uncommon condition.

Given that PPCM presents with signs and symptoms of heart failure (HF) or cardiomyopathy (CM), some women with PPCM may have been given a diagnosis of HF or CM rather than the more specific diagnosis of PPCM. Therefore, data for women who have an ICD code for HF and CM in the same time period will also be included in the dataset; those with a new diagnosis of HF or CM (and with no evidence of an alternative cause and with no prior history of cardiac disease) around the time of delivery, will be identified as possible cases of PPCM. Prior cardiac diagnoses will be applied as exclusion criteria to further describe possible cases and ensure these are as close to ‘true’ PPCM as possible. In addition, researchers will identify possible cases up to 1 year either side of the birth and sensitivity analyses of these time restrictions will be performed. This novel approach of examining possible cases, and expanding the diagnostic window to a year either side of the birth, aims to identify a cohort of women that may have had PPCM, particularly given the changes in the diagnostic criteria over in the past decade.

Researchers therefore request the following cohorts of women:
1-those with a diagnostic code for PPCM
2-women with a diagnostic code for HF or CM in the peripartum period and no prior cardiac history (possible PPCM)

All data will be collected and linked by NHS Digital. Data will be minimised appropriately before dissemination and only relevant ICD10 codes will be provided. Routinely collected hospitalisation data (HES) linked with death records will be used to carry out analysis. The linked data will be presented in a pseudonymised format to the Research Team at University of Glasgow.

Data will be processed in accordance with regulations stipulated by NHS Digital. Only the Data Controller's Clinical Research Fellow (PhD student) will have access to the data. The data will not be shared with a third party. All data is pseudonymised and there will be no need nor any attempt to re-identify individuals.

Data will be accessed via a secure password-protected environment (in line with NHS Digital policy for data storage) at the University of Glasgow British Heart Foundation Glasgow Cardiovascular Research Centre. The following statistical methods will be employed:
- Descriptive analyses of numbers of cases, baseline characteristics and obstetric characteristics; these will be compared across groups of women (definitive PPCM cases and possible PPCM cases). Parametric and nonparametric tests will be used as appropriate.
- The association of ethnicity with the development of PPCM and with outcomes will be examined if there are sufficient numbers to allow this analysis.
- Age-standardised rates of incident PPCM and possible cases will be calculated using census estimates.
- Actuarial life-tables and Kaplan-Meier survival curves will be used to describe maternal and infant/child mortality and risk of subsequent maternal events.
- The association between potential risk factors and the incidence of PPCM, infant/child and maternal outcomes will be analysed using multivariable logistic regression.
- Survival analyses will be performed using the Cox proportional hazards models, the Fine and Grey method for competing risks and joint frailty models for recurrent events.
- All analyses will be subjected to a number of sensitivity analyses.

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).

MR1462 - Data linkage request for the Febuxostat versus Allopurinol Streamlined Trial (FAST). — DARS-NIC-72180-R2L5Y

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Section 251, Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7)

Purposes: Yes (Academic)

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

When:DSA runs 2018-03-16 — 2021-03-15 2018.10 — 2020.05.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF DUNDEE

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. Hospital Episode Statistics Admitted Patient Care
  4. MRIS - Cohort Event Notification Report
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Initial phase III clinical trials of febuxostat suggested that it may be associated with increased cardiovascular risk. Subsequent studies have not supported this risk and a definitive study to confirm or refute this safety concern is still required. The European Union (EU) Risk Management Plan (RMP) for febuxostat (Version 2.0; 19 February 2008) indicates that a post marketing study to evaluate cardiovascular effects of febuxostat is to be conducted as part of the Pharmacovigilance Plan. An outline synopsis of this study was presented as Annex 5 of the RMP.

The FAST study is intended to fulfil this objective. It is a large safety study of febuxostat versus standard urate lowering therapy with allopurinol for chronic symptomatic hyperuricaemia. This study compares the relative cardiovascular safety of the two treatment strategies, and recruitment began in December 2011. Febuxostat is an effective treatment for gout. Aside from meeting the European Medicines Agency regulatory commitments, establishing that this drug is safe in patients who are at risk of cardiovascular disease is of clear benefit, offering an important alternative for managing this condition in a group of patients who are at risk of gout. Other aspects of drug safety are also assessed in the course of this trial by reporting of Serious Adverse Events through the pharmacovigilance process.

Record linkage to national datasets of hospital admissions, deaths and cancer diagnoses is the primary method of identifying Serious Adverse Events and potential cardiovascular endpoints in the FAST study. Identification of all hospitalisations, deaths and diagnoses of cancer allows assessment of the safety of the study interventions, febuxostat and allopurinol. Record linkage output will only be used to identify Serious Adverse Events and study endpoints.

The data will not be used for commercial purposes as this is an academic study involving university research groups. Record level data will only be received by the Robertson Centre for Biostatistics, University of Glasgow. Potential Serious Adverse Events will be identified there, and an anonymised report of these will be sent to the Medicines Monitoring Unit, University of Dundee, where they will be clinically reviewed by medical staff to identify potential endpoints and confirm Serious Adverse Events. This report will not include patient identifiable information, with participants only identified by study number.

The study team at the University of Glasgow request further information about potential endpoint events from the healthcare services involved with the episode of care. This additional clinical information (which does not contain data from NHS Digital) is anonymised by the study team and submitted to a blinded endpoint committee for adjudication, allowing the robust identification of primary and secondary endpoints. Analysis of this data will determine the output of this study.

The results of the FAST study will be disseminated through peer reviewed journals and scientific meetings. Other collaborating academic institutions will not be given access to record level data, but may be given aggregate data (with small numbers suppressed in line with the HES Analysis Guide) for further analysis. All study participants have given written informed consent for the study sponsor to access their electronic or other medical records. The study has been approved by Research Ethics Committee, the MHRA, The European Medicines Agency and local NHS R+D offices.

Yielded Benefits:

The previous data received from NHS Digital has been processed to identify 50 new potential study endpoints and 700 new SAEs within the study.

Expected Benefits:

This research will establish whether febuxostat is as safe as allopurinol with respect to cardiovascular outcomes (stroke, myocardial infarction and cardiovascular death).

This study could result in changes to treatment guidelines in the way patients with gout are treated. The results will also inform regulators about the safety of different gout medications.

Gout is the most common inflammatory arthritis, affecting around 2.5% of UK patients. It causes significant morbidity and impaired quality of life in patients.

Benefits to patients
Patients with gout often have reduced quality of life due to symptoms including pain and limitation of activities. Gout is a longterm condition and it is important to know which medications are safest for prevention of acute attacks of gout in patients.

Benefits to the NHS
Gout causes a significant cost burden on the NHS and costs are likely to increase further as the population ages.

Results of the FAST study are expected to be available in 2020.

Outputs:

Results will be reported in a peer-reviewed journal and at major scientific and clinical meetings. The timescale for this is expected to be around 2020.

The research team believe that the results of this study would be of interest to a high impact factor journal such as the Lancet or New England Journal of Medicine. The research team will organise press releases to coincide with the publication to promote knowledge mobilisation of the study results.

The research team will also present the findings at major cardiovascular and rheumatology scientific and clinical meetings. Target date around 2020 as above.

The research team will also send copies of the results to guideline groups such as NICE (National Institute for Health and Care Excellence) and SIGN (Scottish Intercollegiate Guidelines Network) and ask that they are considered and incorporated appropriately into revisions of guidelines. Target date 2020 as above.

The research team will produce a non-technical summary of the results which the research team will send to patients who participated in the trial, patient groups and gout charities and the research team will work to generate media coverage of the study results and communicate these to the wider public. Target date 2020 as above.

In this case, an additional output will be the determination of adjudicated endpoints/adverse events, which will mean the study can report to the EMA.

Outputs will also be shared with funders, but ownership and control of the outputs rests with the University of Dundee.

Processing:

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 ie: employees, agents and contractors of the Data Recipient who may have access to that data).

There will be no linkage of data provided by NHS Digital to any data, other than as described in this document.

Any data shared outside of the University of Glasgow will contain only data that is aggregated (with small numbers suppressed in line with the HES Analysis Guide). Summary reports of serious adverse events and suspected unexpected serious adverse reaction reports are made to the Medicines and Healthcare products Regulatory Agency (MHRA) in line with clinical trials requirements.
The Robertson Centre for Biostatics (part of the University of Glasgow, acting as Data Processor) will provide:
- Data management (including e-CRF design, database setup and management, data validation)
- Statistical analysis and reporting (final report, Independent Data Monitoring Committee reports)
- Data management and statistical support to record linkage
- provision of support for issues relating to data quality and use of endpoint adjudication system
- project management and quality assurance
- health economic analysis and reporting

Sample size
456 positively adjudicated events will be required to show non-inferiority between the two study treatment arms with 80% statistical power, an upper limit of non-inferiority hazard ratio of 1.3 and a one-sided alpha of 0.025.
It is estimated that 6142 randomised participants, followed up for an average of 3 years will be sufficient to accrue the required 456 positively adjudicated events, allowing for a 20% drop out from the per protocol population.
Data will be received from NHS Digital and linked to trial data, and potential endpoints will be investigated further by obtaining information from medical records. Endpoint packages will be adjudicated by an endpoint committee blinded to treatment allocation.

Data analysis will be carried out according to a pre-determined data analysis plan.

The primary outcome and its individual components (CV death, non-fatal stroke and hospitalisation for non-fatal myocardial infarction/biomarker positive ACS) will be analysed using Cox proportional hazards models including the randomised treatment group and strata (previous cardiovascular events) as covariates. Statistical significance for treatment effects will be based on the Wald statistic and 95% confidence intervals of for the estimated hazard ratio comparing febuxostat to allopurinol.

The primary analysis will be a non-inferiority analysis of the primary outcome based on the per-protocol (on randomised therapy) population. A supporting non-inferiority analysis will then be performed on the intention-to-treat (ITT) population. If non-inferiority is demonstrated, a superiority analysis will be carried out based on the ITT population.

A prospective sensitivity analysis will also be carried out for both primary and secondary outcomes by censoring participant follow-up at 90 days beyond per-protocol period to ascertain if withdrawal is a presage of disease. The possibility of differential drop out in the per-protocol analysis will be adjusted for by in a further analysis adjusting for age, sex, cholesterol levels, systolic blood pressure, smoking status and past medical history of diabetes, hypertension and cardiovascular disease.