NHS Digital Data Release Register - reformatted

Intensive Care National Audit & Research Centre (ICNARC)

Project 1 — DARS-NIC-379807-P3R7Z

Opt outs honoured: Yes - patient objections upheld (Section 251)

Sensitive: Non Sensitive, and Sensitive

When: 2016/09 — 2019/01.

Repeats: Ongoing, One-Off

Legal basis: Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Office for National Statistics Mortality Data
  • Civil Registration - Deaths
  • HES:Civil Registration (Deaths) bridge

Yielded Benefits:

Yielded benefits to date are minimal, as the final linked datasets are yet to be received. Initial models have been developed for longer term mortality following critical care using the initial data extract, however these require updating (as the original extract did not include the full follow-up for mortality) and validating using the additional year of data prior to publication. Models have also been developed for use of critical care following an in-hospital cardiac arrest. These also require further updating and validating with the additional data. All other aspects are yet to commence due to awaiting the required data.

Objectives:

High quality care is at the centre of the NHS. National clinical audit has a key role to play in ensuring high quality care, particularly in areas of health care, such as emergency and critical care, where patient choice does not, and cannot, play a significant part. Sophisticated and accurate risk prediction models are key in underpinning fair comparisons among health care providers. They can also enable risk-adjusted observational research and risk stratification in randomised controlled trials. This study is a follow-on to a previous study that addressed risk prediction modelling in three clinical areas: • adult general critical care; • adult cardiothoracic critical care; and • in-hospital cardiac arrest. The previous study made substantial steps forward in enabling fair comparisons among health care providers in all three areas, with immediate translation of the research outputs into routine practice, but has also identified important and essential new directions for further epidemiological and methodological research. This application is to support a research study funded by the NIHR Health Services and Delivery Research Programme in 2015 that aims to better understand of the following: 1. epidemiology of critical illness, and 2. risk factors for and consequences of critical illness. Increased understanding of these areas and using data linkage with other routinely collected data sources will lead to improvements the risk models used to underpin national clinical audits for: 1. adult general critical care; 2. cardiothoracic critical care; and 3. in-hospital cardiac arrest. The research study is being conducted by researchers from the Intensive Care National Audit & Research Centre (ICNARC), an independent registered charity (charity number: 1039417) which aims to improve critical care services in the UK through a programme of national clinical audits and research studies. ICNARC coordinates two national clinical audits: the Case Mix Programme for adult critical care and the National Cardiac Arrest Audit (coordinated jointly with the Resuscitation Council UK) for in-hospital cardiac arrest. In addition to data linkage with HES/ONS data, the project includes data linkage with other national clinical audits – the UK Renal Registry, the National Diabetes Audit and the National Adult Cardiac Surgery Audit – and representatives from these audits are included in the study team. Once the project is completed, the feasibility and cost of establishing regular, routine data linkage between these data sources will be investigated.

Expected Benefits:

Adult general critical careData linkage between the Case Mix Programme and death registrations will enable ICNARC to develop risk models to predict longer term mortality following an episode of critical illness. Data linkage between the Case Mix Programme and the National Diabetes Audit will enable ICNARC to establish whether acute severity of hyperglycaemia or other risk factors are associated with the likelihood of developing Type 2 diabetes. The occurrence of acute kidney injury (or acute renal failure) is common among critically ill patients and associated with high mortality, and has been strongly linked with subsequent end-stage renal disease. Data linkage between the Case Mix Programme and the UK Renal Registry will enable ICNARC to evaluate this relationship in the UK and develop risk models to predict the requirement for long-term renal replacement among survivors of critical illness in the UK. Data linkage with HES will enable ICNARC to estimate the cost of subsequent hospitalisations and its association with severity and/or duration of critical illness and other risk factors. Adult cardiothoracic critical care Linkage to death registrations from ONS will enable ICNARC to extend risk models for cardiothoracic critical care to predict longer term mortality. Data linkage with HES will enable ICNARC to estimate the cost of subsequent hospitalisations and its association with severity and/or duration of critical illness and other risk factors. In-hospital cardiac arrest Data linkage between National Cardiac Arrest Audit and the Case Mix Programme will allow ICNARC to better understand patterns of critical care, resource use and organ support following successful resuscitation and develop prediction models for likely resource use. Data linkage to ONS will enable ICNARC to extend risk models to predict longer term mortality. Finally, data linkage with HES will enable ICNARC to estimate the cost of subsequent hospitalisations and its association with the measured risk factors. If regular routine data linkage is established, this would permit the risk models and outcome measures developed in this project to be adopted into the national clinical audits to improve the benchmarking of adult critical care and in-hospital cardiac arrest in the UK.

Outputs:

The planned outputs of the project are as follows: 1. A final report on the entire project to be published as a monograph in the NIHR journal, Health Services and Delivery Research. Target date for submission: 15/08/2017. The report will include only aggregate level data on subgroups comprising thousands of patients and will not include any small numbers; therefore small sample suppression will therefore not be required. 2. Journal articles for peer-reviewed scientific journals. A minimum of three journal articles are planned, reporting on the separate areas of the project (adult critical care, cardiothoracic critical care and in-hospital cardiac arrest. However, given the large amount of work planned within each of these areas, it may be appropriate to split one or more of these into more than one article. Target dates for submission: March 2016 to August 2017. Journal articles will include only aggregate level data on subgroups comprising thousands of patients and will not include any small numbers; therefore small sample suppression will therefore not be required. 3. Presentations at professional and scientific conferences, to include the Annual Meeting of the Case Mix Programme (April 2016 and April 2017), the Annual Meeting of the National Cardiac Arrest Audit (October 2016 and October 2017) and the Annual Congress of the European Society of Intensive Care Medicine (October 2017). Presentations will include only aggregate level data on subgroups comprising thousands of patients and will not include any small numbers; therefore small sample suppression will therefore not be required. 4. The final linked anonymised dataset will be retained and stored securely on ICNARC's servers for 10 years. Requests for additional analyses based on this dataset will be managed by ICNARC's independent Data Access Advisory Group in accordance with the MRC Good Practice Principles for Sharing Individual Participant Data from Publically Funded Clinical Trials. Any additional analyses will be restricted to the overall purpose of better understanding the epidemiology of and outcomes from, critical illness. All outputs will be restricted to aggregate data with small numbers supressed in line with the HES analysis guide. 5. Each national clinical audit will retain and securely store the datasets linking each local key with the common key, enabling future studies of linked data to be undertaken subject to necessary REC/Section 251 approvals. Outputs will be shared with the relevant national audit providers. All outputs will be restricted to aggregate data with small numbers supressed in line with the HES analysis guide. Any requests to access data from this project are restricted to those that fall within the overall purpose of the project (to better understand the epidemiology of, and outcomes from, critical illness) and data will only be released in aggregate or summary form with small numbers supressed unless with the express prior permission of HSCIC. Any such permission for the onward sharing of record level data would be subject to a future application.

Processing:

HSCIC will undertake a bespoke data linkage between the linked HES/ONS dataset and external datasets from five national clinical audits: the ICNARC Case Mix Programme (for adult critical care), the National Cardiac Arrest Audit, the UK Renal Registry, the National Diabetes Audit and the National Adult Cardiac Surgery Audit. The index datasets (defining inclusion in the final pseudonymised dataset for analysis) will be the ICNARC Case Mix Programme and the National Cardiac Arrest Audit. The data linkage process will work as follows: each national clinical audit provider will upload to HSCIC's secure file sharing platform datasets consisting of the available identifiers for patients included in each national clinical audit together with an anonymous local key permitting linkage back to locally held data for the audit. HSCIC will link the datasets and return to each national clinical audit provider a dataset consisting of the local key, a common key (permitting linkage across all the datasets) and a binary field indicating whether that patient was identified in either the ICNARC Case Mix Programme or National Cardiac Arrest Audit. The local key is used by the individual audit providers to identify the relevant record within their individual audit systems when it is retuned from the HSCIC along with a common key. The national audit providers do not receive any data other than the two keys and the binary field. Each national audit provider external to ICNARC will then supply direct to ICNARC a pseudonymised dataset of the clinical fields required for the project together with the common key only for those patients identified in either the ICNARC Case Mix Programme or National Cardiac Arrest Audit. HSCIC will provide to ICNARC (via the secure file sharing platform) a pseudonymised data extract of HES/ONS data together with the common key only for patients identified in either the ICNARC Case Mix Programme or National Cardiac Arrest Audit. ICNARC will use the common key to link the data extracts provided by the national audit providers and HSCIC with pseudonymised data extracts from the ICNARC Case Mix Programme and National Cardiac Arrest Audit to create the final linked project dataset. Prior to linkage, ICNARC will pseudonymise the data extracts from the ICNARC Case Mix Programme and National Cardiac Arrest Audit by: replacing date of birth with age in years; and replacing post code with area level deprivation measures. The original datasets do not include patients’ names or full addresses. Once the data are linked, ICNARC will conduct a final pseudonymisation will take place by replacing date of birth with age in years, replacing the date of admission to the critical care unit or date of in-hospital cardiac arrest with the month and year, replacing all other dates in the dataset (including date of death) with the number of days relative to these index dates, replacing post code with area level deprivation measures and replacing hospital/critical care unit names with anonymous identifiers. Consequently, this final pseudonymised dataset will contain no patient identifiable data. The final linked project dataset will be analysed by statisticians at ICNARC (as named in the ONS application). The analyses will describe the epidemiology of, and risk factors for, and develop and validate risk prediction models for, the following outcomes: For admissions to adult critical care units (from the ICNARC Case Mix Programme): mortality at 30 days, 90 days and 1 year (from ONS); time to death (from ONS); new diagnosis of diabetes post-critical care (from the National Diabetes Audit); new diagnosis of end-stage renal disease post-critical care (from the UK Renal Registry); hospital resource use and costs post-critical care (from HES). For admissions to cardiothoracic critical care units (from the ICNARC Case Mix Programme): mortality at discharge from acute hospital; mortality at 30 days, 90 days and 1 year (from ONS); time to death (from ONS); hospital resource use and costs post-critical care. For these analyses, additional risk factor data will be obtained from the National Adult Cardiac Surgery Audit. For patients experiencing in-hospital cardiac arrest (from the National Cardiac Arrest Audit): return of spontaneous circulation (ROSC) for greater than 20 minutes; survival to hospital discharge; survival to 30 days, 90 days and 1 year (from ONS); time to death (from ONS); critical care resource use post-arrest (from the ICNARC Case Mix Programme); Hospital resource use and costs post-arrest (from HES). For these analyses, additional risk factor data will be obtained from HES. Initial data linkage will be undertaken for data from 1 April 2009 to 31 March 2015. These data will be used to describe the epidemiology and develop the risk prediction models. The data linkage will be updated one year later for data from 1 April 2015 to 31 March 2016. These data will be used to validate the risk prediction model


Project 2 — DARS-NIC-46844-W5V5G

Opt outs honoured: N

Sensitive: Sensitive

When: 2017/09 — 2018/02.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Flagging Current Status Report
  • MRIS - Cohort Event Notification Report

Objectives:

The objective for processing these data are to aid the follow-up of patients in the Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial. Data obtained from NHS Digital will be used only to ascertain whether patients taking part in the trial are still alive at six months (the follow-up time point for the POPPI trial). Where ICNARC find out that a patient has passed away, no contact will be made - helping to ensure relatives are not caused undue stress by no longer appropriate contact. The POPPI trial is funded by the National Institute for Health Research Health Services and Delivery Research Programme (funding reference 12/64/124) and is carrying out a clinical and cost-effectiveness evaluation of a nurse-led preventative psychological intervention for patients in intensive care, with the aim of reducing the burden of serious psychological morbidity at six months (which include post-traumatic stress disorder, anxiety and depression). Patients surviving to six months after providing informed consent are sent a follow-up questionnaire (which contains the primary outcome and some secondary outcomes for the trial). Primary outcomes: To evaluate, Patient-reported PTSD symptom severity at six months and Incremental costs, quality adjusted life years and net monetary benefit Secondary outcomes: To compare: Days alive and free from sedation to day 30, Duration of critical care unit stay and Depression at six months. Post traumatic Diagnostic Scale score of greater than 18 points at six months and Health-related quality of life at six months

Expected Benefits:

The main benefit for the data being requested is to ensure that no further contact is made by the POPPI trail with participants who have passed away helping to ensure relatives are not caused undue stress by no longer appropriate contact. Studies indicate high rates of serious psychological morbidity (e.g. post-traumatic stress disorder, anxiety and depression) amongst patients after their stay in a critical care unit. Early psychological assessment of risk and subsequent intervention/support are both key to reduce longer-term psychological morbidity. The Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial sets out to inform the NHS on improving both access to, and delivery of, services to ensure that critically ill patients receive both psychological assessment and intervention/support in a cost-effective manner. The POPPI complex intervention includes creating a more therapeutic environment for patients in the critical care unit, assessing consenting patients for acute psychological stress and, for those identified as acutely stressed, delivering three one to one stress support sessions (which are delivered by a specially trained POPPI nurse). It is not yet known whether this intervention is beneficial for patients (this is what the trial will determine) or cost-effective for the NHS, but if this intervention is found to be clinically and cost-effective, the results of the trial will have a high impact on critical care services in the UK and internationally, particularly as there is no current routine care pathway to address the psychological morbidity of critical care patients in the UK. The primary results of the trial are estimated to be published in March 2018.

Outputs:

The output for the purpose of this request will be the cohort dataset with information about who has passed away and details of the GP practice for all members. This will then be used to enable the appropriate follow up questionnaire to be sent out to all living participants of the POPPI Trial. For the POPPI trail itself the team will prepare and submit a report to the funder - National Institute for Health Research (NIHR) Health Services and Delivery Research Programme. Clinical trials funded by the NIHR are published in the open-access (free of charge) NIHR Journal's Library (http://www.journalslibrary.nihr.ac.uk/), meaning the results can be accessed by patients, carers, clinicians and researchers alike. The estimated publication date for the NIHR report is March 2018. Articles will also be submitted to relevant scientific journals (e.g. medical journals and psychology journals). It will not be possible to identify any person who has taken part in the study in any reports or articles. The results of the POPPI trial will be both widely and actively disseminated. A full detailed report of the POPPI trial will be submitted to the National Institute for Health Research for publication in the peer reviewed, open access Health Services and Delivery Research Programme journal (due to be published in March 2018). The primary results will also be submitted for publication in March 2018 in an high-impact, widely-read, general medical journal, such as the New England Journal of Medicine (this is where the last two large ICNARC trials have also been published). In addition, the results of the POPPI trial will be presented at: regional critical care network meetings; national professional conferences; the Annual Meeting of the ICNARC Case Mix Programme; the Annual Meeting of the UK Critical Care Research Forum; and national and international critical care and clinical and health psychology conferences/meetings. This dissemination plan will ensure that the results of the trial are fed back to those delivering and organising care (e.g. nurses, doctors, managers) in the NHS (and across the world), allowing for any learning from the trial to influence clinical practice for the benefit of critically ill patients. The trial results will also be available to patients and the l public via the ICNARC website (www.icnarc.org) and a press release. [Note: It will not be possible to identify any individual participating patient in any trial reports or presentations].

Processing:

Patients providing informed consent to take part in the POPPI trial have agreed for identifiable information to be collected about them. For patients reaching six months in the trial and who are believed to be alive, their date of birth, postcode, NHS number and patient ID number will be provided to NHS Digital. NHS Digital will then link these identifiers to national records and send back a spread sheet confirming the latest status for each patient, and if relevant, the date of latest posting. The General Practice (GP) code field has been requested to facilitate the follow-up of patients in the trial. Where a patient has not responded to the follow-up questionnaire, the POPPI trial team will contact the patients GP practice to confirm or update contact details. The GP code will be used by the POPPI trial team to enable the patient’s GP practice to be identified rapidly, and ensure follow-up is completed timely. Updated data will then be added to the secure POPPI trial database to ensure no contact is attempted with patients who have passed away. Data collected from NHS Digital will be used only by a limited number authorised individuals in the POPPI trial team who are employed by ICNARC with a legitimate need to use the data (i.e. sending the questionnaires and conducting analysis of the data). Only substantive employees of ICNARC will access the data supplied by NHS Digital. Outputs from the study will contain only aggregate level data with small numbers suppressed in line with HES analysis guide. Red Technology UK and Disaster Recovery UK employees will not access the data. ICNARC will act to preserve patient confidentiality and will not disclose or reproduce any information by which patients could be identified. Data will not be used for commercial purposes, provided in record level form to any third party, and not used for direct marketing.


Project 3 — DARS-NIC-96444-N2B7K

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

Sensitive: Sensitive

When: 2018/06 — 2019/01.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - List Cleaning Report

Objectives:

The 65 Trial is a pragmatic, multi-centre, parallel group randomised clinical trial (RCT) aiming to evaluate the clinical and cost-effectiveness of permissive hypotension (a mean arterial pressure (MAP) target range 60-65 mmHg whilst receiving vasopressors) in critically ill patients aged 65 years or over with vasodilatory hypotension. This research is important to patients and the NHS because of emerging evidence from a meta-analysis suggesting that using a lower MAP target (permissive hypotension) to guide vasopressor treatment may increase survival in older critically ill patients. The prior research has involved too few patients to fully test this idea and therefore guide clinical decision-making, and a large clinical trial (this trial – the 65 Trial) is needed to provide robust evidence as to the effectiveness of using a lower MAP target to guide treatment in critical care. The 65 Trial is funded by the National Institute for Health Research, Health Technology Assessment Programme (reference: 15/80/39), sponsored and managed by the Intensive Care National Audit & Research Centre (ICNARC) (reference: 01/05/17) and aims to include 2,600 participants from approximately 65 NHS adult, general critical care units across England, Wales and Northern Ireland. The primary objective for processing NHS Digital data in this application is to provide important outcome data for the 65 Trial. The outcomes for the trial are: Primary outcomes: • all-cause mortality at 90 days (clinical evaluation) • incremental net monetary benefit (INB), evaluated at the NICE recommended threshold of £20,000 per quality-adjusted life year (QALY), at 90 days (economic evaluation) ICNARC are requesting patient status (i.e. dead, alive, unknown/unable to link) and date of death (if applicable) from NHS Digital to directly contribute to the clinical evaluation primary outcome data (all-cause mortality at 90 days post-randomisation) and the ‘duration of survival to longest available follow-up’ secondary outcome data. Fact of death (as opposed to date of death) would not be sufficient to address these outcomes, as a date is required to calculate the duration of survival. In addition, participants are actively followed-up and sent questionnaires by the 65 Trial team at ICNARC at 90 days and then one year post-randomisation. Given the nature of critical illness, unfortunately some participants will pass away during the trial follow-up period. Participant status and date of death obtained from NHS Digital will therefore allow the researcher to ascertain whether contact at these follow-up time-points is appropriate. Where ICNARC finds out that a participant has passed away, no contact will be made - helping to ensure relatives are not caused undue distress by no longer appropriate contact. Following the end of participant recruitment for the 65 Trial, ICNARC would also like to link the 65 Trial data with Hospital Episode Statistics (HES) data – to provide data to contribute to the integrated economic evaluation. This will be subject to an amendment to this agreement. ICNARC is an independent health research charity which aims to improve the quality of health care in the UK by providing evidence-based research and policy analysis and informing and generating debate. ICNARC requires data from NHS Digital for the purposes of these legitimate interests. Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests. ICNARC have completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override our legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; pseudonymisation to minimise any risk of identifying individuals; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met.

Expected Benefits:

The 65 Trial is a pragmatic, multi-centre, randomised clinical trial to evaluate the clinical and cost-effectiveness of permissive hypotension (mean arterial pressure (MAP) target range 60-65 mmHg whilst receiving vasopressors) in critically ill patients aged 65 years or over with vasodilatory hypotension. There is genuine uncertainty as to which MAP target should be used in critically ill patients in critical care units. It is not yet known whether permissive hypotension is clinically and cost-effective (this is what the 65 Trial will provide information on) but - it is anticipated that if the strategy of permissive hypotension is found to be clinically and cost-effective, that implementation of these outputs into national and international clinical guidelines and subsequently into the NHS will lead to improvements in monitoring and titration of vasopressors in the critical care unit, ensuring a reduction in the potentially unnecessary exposure to vasopressors in elderly patients. This will reduce the burden on patients and their carers and to the NHS. This will need an effective implementation strategy. Active and wide dissemination of the results of the 65 trial will be an important part of this strategy – and will begin upon publication of the primary trial results (estimated to be published before summer 2020). A number of approaches have been identified, including: involving stakeholders; providing evidence in an integrated and graded way; taking account of the context and identifying the elements relevant to decision making, e.g. benefits, harms and costs; making recommendations as specific as possible; and using a multifaceted approach.

Outputs:

The results of the 65 trial will be both widely and actively disseminated. ICNARC has access to both patients and their families and close friends from its recent collaboration in two modules (http://www.healthtalk.org/intensive_care/) for the award-winning website Healthtalk (http://www.healthtalk.org/). In addition, ICNARC works with the Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on the Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The 65 Trial team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the trial are fed-back to patients. In addition, the results will also be available to patients and the public via the ICNARC website (www.icnarc.org). Furthermore, ICNARC has established strong links with the critical care community, which include: a large network of NHS critical care units (>250) in the UK through its National Audit Programme and CTU; close links with the Faculty of Intensive Care Medicine (FICM) and the Intensive Care Society (ICS), the representative body in the UK for critical care professionals (ICNARC has representation on the ICS Council and membership of the ICS Research Committee); close links with the British Association of Critical Care Nurses (BACCN) and the Royal College of Nursing Critical Care and In-flight Nursing Forum (RCN CCINF); representation on the NIHR Comprehensive Clinical Research Network Critical Care Specialty Group; and being one of the founding organisations of the UK Critical Care Research Group. The results of the 65 trial will be presented at: regional critical care network meetings; national professional conferences (e.g. ICS, BACCN, RCN CCINF); the ICNARC Case Mix Programme Annual Conference; the Annual Meeting of the UK Critical Care Research Forum; and national and international critical care conferences/meetings. This dissemination plan will ensure that the results of the 65 Trial are fed back to those delivering and organising care (e.g. nurses, doctors, managers) in the NHS (and across the world), allowing for any learning from the 65 Trial to influence clinical practice for the benefit of critically ill patients. [Note: It will not be possible to identify any individual participating patient in any trial reports or presentations]. A comprehensive report will be submitted to the NIHR for publication in the peer reviewed, open access Health Technology Assessment journal and will include recommendations for future policy, practice and research. The results will also be submitted for publication in a high-impact, widely-read, open-access (where possible), general medical journal, such as the New England Journal of Medicine (where the last two large ICNARC trials have been published). Both of these reports will be submitted for publication in October 2019, and expected to be published before summer 2020. All data presented/reported will be aggregated at a national level, with small numbers suppressed in line with HES analysis guide. It will not be possible to identify any individual participating patient in any reports, articles or presentations.

Processing:

On a monthly basis, for accruing trial participants, an authorised member of the 65 Trial team at the ICNARC CTU will provide one excel spreadsheet, securly via SEFT, to NHS Digital. The excel spreadsheet will contain participants’ 65 Trial number, name, date of birth, postcode and NHS number. These data are identifiable, provided at record level and sent to NHS Digital on a monthly basis while the trial is ongoing. The cohort size is between 1,500 and 2,600. NHS Digital will then link these data to create a list cleaning report to confirm each patients’ status (at that point in time), and, if relevant, date of death. NHS Digital will provide an excel spreadsheet to an authorised member of the 65 Trial team at the ICNARC CTU that contains the following: 65 Trial number, patient status, and death of death (if relevant). NHS Digital should also indicate where it has not been possible to complete linkage (e.g. unable to link). These data are pseudonymised, returned with a study id and provided at record level. The data received from NHS Digital will be incorporated into the record level 65 Trial database, stored on secure servers, managed by Red Technology Ltd, on behalf of ICNARC. In addition, ICNARC will regularly back-up the data through Disaster Recovery Service Ltd (DRS). Both Red Technology Ltd and DRS are contractors authorised by ICNARC and whom both have sufficient security assurances in place. Red Technology UK and Disaster Recovery UK employees will not access the data. The data will be analysed by authorised members of the 65 Trial team at the ICNARC CTU. All outputs will be aggregated at a national level, with small numbers suppressed in line with HES analysis guide. It will not be possible to identify any individual participating patient in any reports, articles or presentations. Once analysis and primary dissemination is complete, the data will be archived for five years. After five years, data will be anonymised, and identifiable data confidentially destroyed from all locations (ICNARC, Red Technology Ltd and DRS). 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).