NHS Digital Data Release Register - reformatted
INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC) projects
- Intensive Care Unit Randomised Trial Comparing Two Approachesto OXygen Therapy (UK-ROX) - Section 251 and Consultee
- Intensive Care Unit Randomised Trial Comparing Two Approaches to OXygen Therapy (UK-ROX) - Consent
- FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): A master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care
- MR1467 - The 65 Trial: Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension
- Renal Replacement Anticoagulant Management (RRAM)
- MR1436 - Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial
- Risk modelling in the critically ill
181 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Intensive Care Unit Randomised Trial Comparing Two Approachesto OXygen Therapy (UK-ROX) - Section 251 and Consultee — DARS-NIC-754519-V1T5M
Type of data: information not disclosed for TRE projects
Opt outs honoured: Identifiable (Section 251 NHS Act 2006)
Legal basis: Health and Social Care Act 2012 s261(4); National Health Service Act 2006 - s251 - 'Control of patient information'.
Purposes: No (Research)
Sensitive: Sensitive, and Non-Sensitive
When:DSA runs 2024-08-16 — 2027-07-22
Access method: One-Off
Data-controller type: INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
Datasets:
- Civil Registrations of Death
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Outpatients (HES OP)
Objectives:
Intensive Care National Audit & Research Centre (ICNARC) requires access to NHS England data for the purpose of the following research project: Intensive Care Unit Randomised Trial Comparing Two Approaches to OXygen Therapy (UK-ROX)
The following is a summary of the aims of the research project provided by ICNARC:
UK-ROX is a large-scale, multi-centre, data-enabled, registry-embedded, randomised clinical trial (RCT) aiming to evaluate the clinical and cost-effectiveness of conservative oxygen therapy versus usual oxygen therapy, in adults receiving invasive mechanical ventilation (MV) with supplemental oxygen following an unplanned ICU admission. Oxygen is one of the most common treatments given to patients in the ICU. However, there is currently insufficient evidence to guide clinicians in the use of oxygen to minimise the potential harm caused by giving too little or too much oxygen. The long-standing fear of harm due to hypoxia from giving too little oxygen has led to a tendency to give too much oxygen in order to counter-balance this. However, giving too much oxygen risks damaging the lungs and other vital organs.
The importance of this research is demonstrated by the large number of critically ill patients requiring MV treated in NHS ICUs each year. Of the 337,312 admissions to ICUs participating in the Case Mix Programme (CMP - national clinical audit of adult critical care) between 1 April 2017 and 31 March 2019, 96,028 (29%) received MV during their stay. Of these, 34% died before hospital discharge, extending to an anticipated 37% by 90 days. Prior to starting the UK-ROX trial, the UK-ROX trial team conducted a meta-analysis (a method of combining the results of previous clinical trials carried out answering a similar research question). With the risk ratio from the meta-analysis of 0.91 (0.75 to 1.09) in favour of more conservative oxygen therapy, if a similar effect size is observed in UK-ROX, this would equate to >3,000 lives saved annually in the UK if the intervention was implemented. Optimising oxygen therapy may also reduce the financial burden of critical illness on society by reducing morbidity and improving quality of life after discharge. The proportion of admissions to adult ICUs in the UK receiving MV has remained >30% over the past 10 years and is expected to rise with increasing admissions of elderly patients. The recent COVID-19 pandemic, in which 72% of ICU patients with COVID-19 received MV demonstrates the need for a comprehensive evidence base for patients requiring MV as part of their ICU care. As a specialised high-cost service, it is imperative to optimise treatments that are delivered to large proportions of ICU patients.
ICNARC aim to conduct an ambitious, cost-efficient, data-enabled trial to address a fundamental knowledge gap in intensive care medicine. ICNARC will evaluate the clinical effectiveness of conservative oxygen therapy (versus usual oxygen therapy) on 90-day all-cause mortality and its cost-effectiveness for incremental costs, quality-adjusted life years (QALYs) and net monetary benefit at 90 days. ICNARC propose an RCT that will recruit 16,500 MV ICU patients into either conservative or usual oxygen therapy. ICNARC wish to provide a definitive answer as to whether reducing the amount of oxygen given to ICU patients receiving MV improves their survival and from this develop national guidance that can be easily and immediately implemented throughout the NHS.
The primary objective for processing NHS England Data in this agreement is to provide important outcome data for UK-ROX. The outcomes for the trial are:
1. Primary outcome:
90-day all-cause mortality
2. Secondary outcomes:
In-hospital mortality (censored at 90 days)
Mortality at ICU discharge, 60-days and one-year
Duration of ICU and acute hospital stay (censored at 90 days)
Health-related Quality of Life (HrQoL), assessed using the EuroQol EQ-5D-5L questionnaire (descriptive system; patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement), at 90 days
3. Primary economic evaluation outcome:
Incremental costs, quality-adjusted life years (QALYs) and net monetary benefit at 90 days
4. Secondary economic evaluation outcomes:
HrQoL, assessed using the EuroQol EQ-5D-5L questionnaire, at 90-days
Resource use and costs at 90 days
Estimated lifetime incremental cost-effectiveness.
Data from NHS England is requested to contribute to the analysis of the study outcomes, alongside separate trial data collected from hospital records at participating sites and reported outcomes from the participants themselves.
Common Law Duty of Confidentiality and Patient Objections:
The decision to initiate invasive mechanical ventilation is most often made during a time-sensitive emergency, where any delay in commencing treatment could be detrimental to the patient and the scientific validity of the trial. Attempts to obtain fully informed prospective consent would not be appropriate during such an emergency patients will lack capacity to consent during this time, and approaching their Personal Consultee (relative/friend) could cause additional stress to family/ friends who are already very distressed by the patients critical illness. In addition, the oxygen target range used in the conservative oxygen group is relatively safe and is not outside the range which can be used in current clinical practice, as determined by treating clinicians.
Considering these reasons, a deferred consent model (research without prior consent) has been utilised in the UK-ROX trial, a model that has been found to be acceptable to patients and clinicians in several previous RCTs conducted in the critical care setting. This consent model has been informed and refined by patient and public involvement (PPI). The South Central - Oxford C Research Ethics Committee have approved these consent procedures and granted an emergency waiver of consent.
This DSA (DARS-NIC-754519-V1T5M-v0) only covers patients who have had consultee opinion or where the common law duty of confidentiality is addressed by section 251 support. A separate DSA, DARS-NIC-427962-M3K1W-v0, covers patients who have provided informed deferred consent. The DSAs have been separated due to operational reasons.
The following NHS England Data will be accessed:
> Hospital Episode Statistics (HES) Admitted Patient Care (APC) and HES Outpatients (OP) necessary to understand the economic impact of conservative oxygen therapy versus usual oxygen therapy.
> Civil Registration Mortality necessary to investigate the primary and secondary outcomes of the study.
Patient date of death is requested from NHS England to directly contribute to the clinical evaluation primary outcome data (all-cause mortality at 90 days) and secondary outcome data (all-cause mortality at 1 year, for patients who reach this time point during the trial) (primary purposes). In addition, a subset of trial participants (15%, n = 2475) are actively followed-up and sent a questionnaire by the UK-ROX trial team at ICNARC at 90 days post-randomisation. Given the nature of critical illness, unfortunately some participants will pass away during the trial follow-up period. Where the trial team learns that a participant has passed away, no contact will be made - helping to ensure relatives are not caused unnecessary distress by inappropriate contact (secondary purpose).
The level of the Data will be:
> Identifiable - The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. Although ICNARC have the technical ability to re-identify participants, there will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.
The Data will be minimised as follows:
> Limited to a study cohort identified by ICNARC 7,400 patients where consultee advice has been provided or section 251 support has been obtained to address the common law duty of confidentiality from around 100 NHS critical care units across England, Wales, and Northern Ireland. Of those, 7,000 are from England and 400 are from Wales. Recruitment is ongoing.
> Limited to data between 2021/22 - 2024/25; This is because recruitment commenced in May 2021 and will continue till November 2024, with the final participant requiring follow up in February 2025 (the final data collection timepoint for this cohort) and data is required to cover this period.
> Limited to England and Wales.
> Following data receipt, ICNARC will minimise the data by date of randomisation per patient.
ICNARC is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.
ICNARC has determined the processing is necessary for its legitimate interests in being able to benefit healthcare organisations. ICNARC is an independent health research charity which aims to help improve the quality of critical care through audit, research and education with, and in the interests of, patients and those who care for them. ICNARC requires data from NHS England for the purposes of these legitimate interests. ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research.
Processing personal data is necessary for ICNARC's legitimate interests which are described in this agreement. The Data to which access is requested are proportionate and necessary to achieve those interests. ICNARC has completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override ICNARCs 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 England or after a defined period on completion of the project.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients treatments or care.
The funding is provided by the National Institute for Health and Care Research (NIHR), Health Technology Assessment Programme. The funding is specifically for the UK-ROX trial described.
The funder will have no ability to suppress or otherwise limit the publication of findings.
London School of Hygiene and Tropical Medicine (LSHTM) is a processor acting under the instructions of ICNARC. LSHTMs role is limited to health economic analyses as the UK-ROX trial teams health economist is based at LSHTM.
Babble Cloud provides IT hosting services to ICNARC and will store the Data as contracted by ICNARC.
Exponential-E provides IT back up services to ICNARC and will store copies of the Data as contracted by ICNARC.
The Trial Management Group includes members from the following organisations: University of Plymouth, University of Southampton, Maidstone and Tunbridge Wells NHS Trust, Salford Royal NHS Foundation Trust, South Tyneside and Sunderland NHS Foundation Trust, Cardiff University, Wellington Regional Hospital (New Zealand), LSHTM, and ICNARC. However, only ICNARC and LSHTM will receive and process NHS England Data.
The Trial Management Group includes individuals responsible for the day-to-day management of the trial, such as the Chief Investigators, statistician, trial manager, research nurse, data manager. The role of the group is to monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to and take appropriate action to safeguard participants and the quality of the trial itself; members of the Trial Management Group have no control over the aims and objectives of this project, and as such, they only provide expertise and advice, and do not make data processing decisions as part of the Group.
Public and Patient Involvement (PPI) helped refine the purpose of the research and supported the collection of the data for the purposes described above. PPI has been, and is, central to the development and oversight of the UK-ROX trial. A patient representative is a co-investigator on the UK-ROX trial and has contributed significantly into the development of the trial. This has included the development and refinement of the consent procedures and consent materials (including the patient information sheets and consent forms), helping to ensure the acceptability of the trial and its procedures to patients. The patient representative contributes to the ongoing management of the trial, as a member of the Trial Management Group. The Trial Steering Committee, a majority-independent committee which oversees the trial on behalf of the Funder and Sponsor, also includes independent PPI representation.
Expected Benefits:
The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.
In the UK, around 184,000 people are admitted to an adult intensive care unit (ICU) each year. Over 30% (55,000) of these receive advanced respiratory support in the form of mechanical ventilation (MV) with supplemental oxygen. This makes oxygen one of the commonest drugs administered to patients in ICU. Despite this, there is genuine uncertainty surrounding the best amount of oxygen to give to patients to improve survival and quality of life outcomes. It is not yet known whether conservative oxygen therapy is clinically and cost-effective compared to usual oxygen therapy, in which clinicians tend to aim for higher targets. UK-ROX will examine which treatment is best in terms of clinical and cost-effectiveness, and it is anticipated that if either treatment is found to be superior, this finding may be implemented into national and international clinical guidelines and subsequently the NHS. This may lead to improvements in the delivery of invasive mechanical ventilation with supplemental oxygen, ensuring that the amount of oxygen given to patients would be informed by robust and high-quality RCT evidence.
The use of the data could lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
ICNARC anticipate the results to be easily adopted into clinical practice as it is a simple change in target range and does not rely upon a new drug or device becoming available. The team includes experts in guidelines and dissemination of RCTs and expect the results to influence global practice. This may reduce the burden on patients, their carers, and critical care units within the NHS and globally. It is not currently known if conservative oxygen therapy is beneficial for critically ill patients receiving mechanical ventilation in the ICU, however, if the hypothesis is true and the intervention is found to be clinically effective, participants in the intervention group and future critically ill patients within the NHS and worldwide may benefit from increased survival. The NHS and healthcare systems worldwide may also benefit in terms of net monetary benefit, if the intervention is found to be cost effective.
This research is important to patients and the NHS, because it aims to evaluate the best amount of oxygen to give to patients to increase the likelihood of survival and improve quality of life. The findings of UK-ROX may help guide clinical decision making and inform critical care clinicians and the wider NHS on the clinical and cost effectiveness of conservative oxygen therapy versus usual oxygen therapy.
It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies and organisations charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.
Active and wide dissemination of the results of UK-ROX is an important part of the implementation strategy and will begin upon publication of the primary trial results (see Specific outputs expected, including target date for further details). 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.
Dissemination will be led by the chief investigators working closely with ICNARC CTU and supported by other members of the Trial Management Group. Dissemination of the results will commence in 2025. In line with ICNARCs legitimate interest of processing data for research and statistical purposes - the public (e.g. future critically ill patients) and the NHS will receive the benefits of the processing. Results of UK-ROX will help to guide critical care clinicians and the wider NHS on the clinical and cost-effectiveness of conservative oxygen therapy versus usual oxygen therapy.
ICNARC will engage patients and their families to disseminate the study progress and results through the trial website, social media, and newsletters, which will be provided to participants with the follow-up questionnaires. Wider patient and public engagement will be facilitated by the co-applicants and members of the research team, who have extensive connections with critical care communities. The PPI co-applicant will be central to ensuring the outputs from UK-ROX are patient centred and disseminated through patient networks.
ICNARC has strong relationships with critical care patients, their families, and close friends, through previous collaborations on two modules for the award winning website Healthtalk and with Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), a registered charity run by former intensive care patients and their relatives, which collaborated on previous Family Reported Experiences Evaluation Study funded by the Health Services and Delivery Research (HS&DR) programme (11/2003/56). The HS&DR Programme aims to produce rigorous and relevant evidence to improve the quality, accessibility and organisation of health and social care services.
Outputs:
The expected outputs of the processing will be:
> A Study Report, detailing the project and the results along with the recommendations for future policy, practice, and research, will be submitted to the National Institute for Health Research, Health Technology Assessment (NIHR HTA) for publication. The NIHR HTA report will be submitted for publication in June 2025. HTA publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
> Submissions to high-impact, open-access, peer reviewed scientific journals and relevant professional journals. The primary results will be submitted for publication following the completion of recruitment, follow-up, and analysis, anticipated to be April 2025.
> Presentations at appropriate conferences, such as the Critical Care Reviews (CCR) Annual Meeting; European Society of Intensive Care Medicine (ESICM) Annual Congress; Intensive Care Society (ICS) Annual Conference; British Association of Critical Care Nurses (BACCN) Annual Conference; the Case Mix Programme Annual Conference and Exhibition; and the Annual Meeting of the UK Critical Care Research Forum. It is anticipated that the findings will be presented from 2025 onwards.
The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
> Journals
> Conferences
> Study website
> Social media including the Study X/Twitter page and ICNARCs X/Twitter page. ICNARC has more than 10,000 followers which can be used to actively publicise progress with the research and disseminate the findings.
> The research team has strong links with the critical care community will help ensure that UK-ROX is at the forefront of the critical care communitys research agenda throughout the duration of the trial. This includes: the Faculty of Intensive Care Medicine (FICM), Intensive Care Society (ICS), British Association of Critical Care Nurses (BACCN), Royal College of Nursing Critical Care In-flight Nursing Forum (RC CCINF), NIHR Clinical Research Network Critical Care National Speciality Group and the UK Critical Care Research Group.
> One of the co-chief investigators on the trial is a member of the Academy of Medical Royal Colleges Academic Leads Committee.
> Professional societies concerned with the care of critically ill patients, including the ICS and FICM, provide them with evidence to inform future clinical guidelines arising from the research.
> Presentation slides and briefing papers will be prepared for use by the study team to disseminate the research findings.
Outputs are expected to be produced throughout 2025.
Processing:
ICNARC will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth and Postcode) and a unique person ID (UK-ROX Trial Number) for the cohort to be linked with NHS England data.
NHS England will provide the relevant records from the HES and mortality datasets to ICNARC. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.
ICNARC will securely transfer the Data to LSHTM. Some Data may be derived before data transfer, but the majority of the NHS England Data is required by LSHTM for their economic analysis.
The Data will be stored on servers provided by Exponential-E to ICNARC and at LSHTM.
ICNARC uses offsite back-up services provided by Exponential-E.
ICNARC also stores Data on the Cloud provided by Babble Cloud.
The Data will be accessed by authorised personnel via remote access.
The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.
For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisations DSPT (or other security arrangements as per this DSA) and complies with the organisations remote access policy.
The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).
The Data will not leave England and Wales at any time. Remote processing will be from secure locations within England/Wales.
Access is restricted to employees of ICNARC and LSHTM who have authorisation from the UK-ROX trial team.
All personnel accessing the Data have been appropriately trained in data protection and confidentiality.
The Data will be linked at person record level with the individual UK-ROX trial participant trial data, which contains details of oxygen and ventilation treatment in ICU (obtained from participating hospitals) and quality of life questionnaires completed by patients, using the UK-ROX trial number.
The UK-ROX trial team at ICNARC will additionally create a fully pseudonymised trial dataset which will be linked to both the pseudonymised mortality data, and the pseudonymised HES data from NHS England using the unique trial number field. The pseudonymised linked record level dataset will also be made available to the health economist, who is part of the UK-ROX trial team, based at the London School of Hygiene and Tropical Medicine (LSHTM) who will conduct the health economic evaluation.
The subsequent analyses will directly answer the trial research questions and achieve the purpose of finding out whether conservative oxygen therapy is superior to usual oxygen therapy, for the benefit of future NHS patients.
The Data will not be linked with any other data.
Access to patient identifiable data is restricted according to ICNARCs data access policies and procedures with access restricted to named individuals on a need-to-know basis, using auditable information systems.
Identifiable data will be anonymised within one year of the end of the study and the identifiers will be confidentially destroyed from all locations (ICNARC, Exponential-E). The dataset shared with LSHTM will contain no identifiers.
Analysts from ICNARC and LSHTM will analyse the Data for the purposes described above.
Intensive Care Unit Randomised Trial Comparing Two Approaches to OXygen Therapy (UK-ROX) - Consent — DARS-NIC-427962-M3K1W
Type of data: information not disclosed for TRE projects
Opt outs honoured: Identifiable (Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 s261(2)(c)
Purposes: No (Research)
Sensitive: Sensitive
When:DSA runs 2024-08-07 — 2027-08-06
Access method: One-Off
Data-controller type: INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
Datasets:
- Civil Registrations of Death
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Outpatients (HES OP)
Objectives:
Intensive Care National Audit & Research Centre (ICNARC) requires access to NHS England data for the purpose of the following research project: Intensive Care Unit Randomised Trial Comparing Two Approaches to OXygen Therapy (UK-ROX)
The following is a summary of the aims of the research project provided by ICNARC:
UK-ROX is a large-scale, multi-centre, data-enabled, registry-embedded, randomised clinical trial (RCT) aiming to evaluate the clinical and cost-effectiveness of conservative oxygen therapy versus usual oxygen therapy, in adults receiving invasive mechanical ventilation (MV) with supplemental oxygen following an unplanned ICU admission. Oxygen is one of the most common treatments given to patients in the ICU. However, there is currently insufficient evidence to guide clinicians in the use of oxygen to minimise the potential harm caused by giving too little or too much oxygen. The long-standing fear of harm due to hypoxia from giving too little oxygen has led to a tendency to give too much oxygen in order to counter-balance this. However, giving too much oxygen risks damaging the lungs and other vital organs.
The importance of this research is demonstrated by the large number of critically ill patients requiring MV treated in NHS ICUs each year. Of the 337,312 admissions to ICUs participating in the Case Mix Programme (CMP - national clinical audit of adult critical care) between 1 April 2017 and 31 March 2019, 96,028 (29%) received MV during their stay. Of these, 34% died before hospital discharge, extending to an anticipated 37% by 90 days. Prior to starting the UK-ROX trial, the UK-ROX trial team conducted a meta-analysis (a method of combining the results of previous clinical trials carried out answering a similar research question). With the risk ratio from the meta-analysis of 0.91 (0.75 to 1.09) in favour of more conservative oxygen therapy, if a similar effect size is observed in UK-ROX, this would equate to >3,000 lives saved annually in the UK if the intervention was implemented. Optimising oxygen therapy may also reduce the financial burden of critical illness on society by reducing morbidity and improving quality of life after discharge. The proportion of admissions to adult ICUs in the UK receiving MV has remained >30% over the past 10 years and is expected to rise with increasing admissions of elderly patients. The recent COVID-19 pandemic, in which 72% of ICU patients with COVID-19 received MV demonstrates the need for a comprehensive evidence base for patients requiring MV as part of their ICU care. As a specialised high-cost service, it is imperative to optimise treatments that are delivered to large proportions of ICU patients.
ICNARC aim to conduct an ambitious, cost-efficient, data-enabled trial to address a fundamental knowledge gap in intensive care medicine. ICNARC will evaluate the clinical effectiveness of conservative oxygen therapy (versus usual oxygen therapy) on 90-day all-cause mortality and its cost-effectiveness for incremental costs, quality-adjusted life years (QALYs) and net monetary benefit at 90 days. ICNARC propose an RCT that will recruit 16,500 MV ICU patients into either conservative or usual oxygen therapy. ICNARC wish to provide a definitive answer as to whether reducing the amount of oxygen given to ICU patients receiving MV improves their survival and from this develop national guidance that can be easily and immediately implemented throughout the NHS.
The primary objective for processing NHS England Data in this agreement is to provide important outcome data for UK-ROX. The outcomes for the trial are:
1. Primary outcome:
90-day all-cause mortality
2. Secondary outcomes:
In-hospital mortality (censored at 90 days)
Mortality at ICU discharge, 60-days and one-year
Duration of ICU and acute hospital stay (censored at 90 days)
Health-related Quality of Life (HrQoL), assessed using the EuroQol EQ-5D-5L questionnaire (descriptive system; patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement), at 90 days
3. Primary economic evaluation outcome:
Incremental costs, quality-adjusted life years (QALYs) and net monetary benefit at 90 days
4. Secondary economic evaluation outcomes:
HrQoL, assessed using the EuroQol EQ-5D-5L questionnaire, at 90-days
Resource use and costs at 90 days
Estimated lifetime incremental cost-effectiveness.
Data from NHS England is requested to contribute to the analysis of the study outcomes, alongside separate trial data collected from hospital records at participating sites and reported outcomes from the participants themselves.
Common Law Duty of Confidentiality and Patient Objections:
The decision to initiate invasive mechanical ventilation is most often made during a time-sensitive emergency, where any delay in commencing treatment could be detrimental to the patient and the scientific validity of the trial. Attempts to obtain fully informed prospective consent would not be appropriate during such an emergency patients will lack capacity to consent during this time, and approaching their Personal Consultee (relative/friend) could cause additional stress to family/ friends who are already very distressed by the patients critical illness. In addition, the oxygen target range used in the conservative oxygen group is relatively safe and is not outside the range which can be used in current clinical practice, as determined by treating clinicians.
Considering these reasons, a deferred consent model (research without prior consent) has been utilised in the UK-ROX trial, a model that has been found to be acceptable to patients and clinicians in several previous RCTs conducted in the critical care setting. This consent model has been informed and refined by patient and public involvement (PPI). The South Central - Oxford C Research Ethics Committee have approved these consent procedures and granted an emergency waiver of consent.
This DSA (DARS-NIC-427962-M3K1W-v0) covers only patients who have provided informed deferred consent. A separate DSA, DARS-NIC-754519-V1T5M-v0, covers patients who have had consultee opinion or where the common law duty of confidentiality is addressed by section 251 support. The DSAs have been separated due to operational reasons.
The following NHS England Data will be accessed:
> Hospital Episode Statistics (HES) Admitted Patient Care (APC) and HES Outpatients (OP) necessary to understand the economic impact of conservative oxygen therapy versus usual oxygen therapy.
> Civil Registration Mortality necessary to investigate the primary and secondary outcomes of the study.
Patient date of death is requested from NHS England to directly contribute to the clinical evaluation primary outcome data (all-cause mortality at 90 days) and secondary outcome data (all-cause mortality at 1 year, for patients who reach this time point during the trial) (primary purposes). In addition, a subset of trial participants (15%, n = 2475) are actively followed-up and sent a questionnaire by the UK-ROX trial team at ICNARC at 90 days post-randomisation. Given the nature of critical illness, unfortunately some participants will pass away during the trial follow-up period. Where the trial team learns that a participant has passed away, no contact will be made - helping to ensure relatives are not caused unnecessary distress by inappropriate contact (secondary purpose).
The level of the Data will be:
> Identifiable - The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. Although ICNARC have the technical ability to re-identify participants, there will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.
The Data will be minimised as follows:
> Limited to a study cohort identified by ICNARC 7,300 consented patients from around 100 NHS critical care units across England, Wales, and Northern Ireland. Of those, 6,800 are from England and 500 are from Wales. Recruitment is ongoing. Participants who declined or withdrew consent for data linkage will not be included in the cohort submitted to NHS England for linkage purposes.
> Limited to data between 2021/22 - 2024/25; This is because recruitment commenced in May 2021 and will continue till November 2024, with the final participant requiring follow up in February 2025 (the final data collection timepoint for this cohort) and data is required to cover this period.
> Limited to England and Wales.
> Following data receipt, ICNARC will minimise the data by date of randomisation per patient.
ICNARC is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.
ICNARC has determined the processing is necessary for its legitimate interests in being able to benefit healthcare organisations. ICNARC is an independent health research charity which aims to help improve the quality of critical care through audit, research and education with, and in the interests of, patients and those who care for them. ICNARC requires data from NHS England for the purposes of these legitimate interests. ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research.
Processing personal data is necessary for ICNARC's legitimate interests which are described in this agreement. The Data to which access is requested are proportionate and necessary to achieve those interests. ICNARC has completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override ICNARCs 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 England or after a defined period on completion of the project.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients treatments or care.
The funding is provided by the National Institute for Health and Care Research (NIHR), Health Technology Assessment Programme. The funding is specifically for the UK-ROX trial described.
The funder will have no ability to suppress or otherwise limit the publication of findings.
London School of Hygiene and Tropical Medicine (LSHTM) is a processor acting under the instructions of ICNARC. LSHTMs role is limited to health economic analyses as the UK-ROX trial teams health economist is based at LSHTM.
Babble Cloud provides IT hosting services to ICNARC and will store the Data as contracted by ICNARC.
Exponential-E provides IT back up services to ICNARC and will store copies of the Data as contracted by ICNARC.
The Trial Management Group includes members from the following organisations: University of Plymouth, University of Southampton, Maidstone and Tunbridge Wells NHS Trust, Salford Royal NHS Foundation Trust, South Tyneside and Sunderland NHS Foundation Trust, Cardiff University, Wellington Regional Hospital (New Zealand), LSHTM, and ICNARC. However, only ICNARC and LSHTM will receive and process NHS England Data.
The Trial Management Group includes individuals responsible for the day-to-day management of the trial, such as the Chief Investigators, statistician, trial manager, research nurse, data manager. The role of the group is to monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to and take appropriate action to safeguard participants and the quality of the trial itself; members of the Trial Management Group have no control over the aims and objectives of this project, and as such, they only provide expertise and advice, and do not make data processing decisions as part of the Group.
Public and Patient Involvement (PPI) helped refine the purpose of the research and supported the collection of the data for the purposes described above. PPI has been, and is, central to the development and oversight of the UK-ROX trial. A patient representative is a co-investigator on the UK-ROX trial and has contributed significantly into the development of the trial. This has included the development and refinement of the consent procedures and consent materials (including the patient information sheets and consent forms), helping to ensure the acceptability of the trial and its procedures to patients. The patient representative contributes to the ongoing management of the trial, as a member of the Trial Management Group. The Trial Steering Committee, a majority-independent committee which oversees the trial on behalf of the Funder and Sponsor, also includes independent PPI representation.
Expected Benefits:
The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.
In the UK, around 184,000 people are admitted to an adult intensive care unit (ICU) each year. Over 30% (55,000) of these receive advanced respiratory support in the form of mechanical ventilation (MV) with supplemental oxygen. This makes oxygen one of the commonest drugs administered to patients in ICU. Despite this, there is genuine uncertainty surrounding the best amount of oxygen to give to patients to improve survival and quality of life outcomes. It is not yet known whether conservative oxygen therapy is clinically and cost-effective compared to usual oxygen therapy, in which clinicians tend to aim for higher targets. UK-ROX will examine which treatment is best in terms of clinical and cost-effectiveness, and it is anticipated that if either treatment is found to be superior, this finding may be implemented into national and international clinical guidelines and subsequently the NHS. This may lead to improvements in the delivery of invasive mechanical ventilation with supplemental oxygen, ensuring that the amount of oxygen given to patients would be informed by robust and high-quality RCT evidence.
The use of the data could lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
ICNARC anticipate the results to be easily adopted into clinical practice as it is a simple change in target range and does not rely upon a new drug or device becoming available. The team includes experts in guidelines and dissemination of RCTs and expect the results to influence global practice. This may reduce the burden on patients, their carers, and critical care units within the NHS and globally. It is not currently known if conservative oxygen therapy is beneficial for critically ill patients receiving mechanical ventilation in the ICU, however, if the hypothesis is true and the intervention is found to be clinically effective, participants in the intervention group and future critically ill patients within the NHS and worldwide may benefit from increased survival. The NHS and healthcare systems worldwide may also benefit in terms of net monetary benefit, if the intervention is found to be cost effective.
This research is important to patients and the NHS, because it aims to evaluate the best amount of oxygen to give to patients to increase the likelihood of survival and improve quality of life. The findings of UK-ROX may help guide clinical decision making and inform critical care clinicians and the wider NHS on the clinical and cost effectiveness of conservative oxygen therapy versus usual oxygen therapy.
It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies and organisations charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.
Active and wide dissemination of the results of UK-ROX is an important part of the implementation strategy and will begin upon publication of the primary trial results (see Specific outputs expected, including target date for further details). 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.
Dissemination will be led by the chief investigators working closely with ICNARC CTU and supported by other members of the Trial Management Group. Dissemination of the results will commence in 2025. In line with ICNARCs legitimate interest of processing data for research and statistical purposes - the public (e.g. future critically ill patients) and the NHS will receive the benefits of the processing. Results of UK-ROX will help to guide critical care clinicians and the wider NHS on the clinical and cost-effectiveness of conservative oxygen therapy versus usual oxygen therapy.
ICNARC will engage patients and their families to disseminate the study progress and results through the trial website, social media, and newsletters, which will be provided to participants with the follow-up questionnaires. Wider patient and public engagement will be facilitated by the co-applicants and members of the research team, who have extensive connections with critical care communities. The PPI co-applicant will be central to ensuring the outputs from UK-ROX are patient centred and disseminated through patient networks.
ICNARC has strong relationships with critical care patients, their families, and close friends, through previous collaborations on two modules for the award winning website Healthtalk and with Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), a registered charity run by former intensive care patients and their relatives, which collaborated on previous Family Reported Experiences Evaluation Study funded by the Health Services and Delivery Research (HS&DR) programme (11/2003/56). The HS&DR Programme aims to produce rigorous and relevant evidence to improve the quality, accessibility and organisation of health and social care services.
Outputs:
The expected outputs of the processing will be:
> A Study Report, detailing the project and the results along with the recommendations for future policy, practice, and research, will be submitted to the National Institute for Health Research, Health Technology Assessment (NIHR HTA) for publication. The NIHR HTA report will be submitted for publication in June 2025. HTA publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
> Submissions to high-impact, open-access, peer reviewed scientific journals and relevant professional journals. The primary results will be submitted for publication following the completion of recruitment, follow-up, and analysis, anticipated to be April 2025.
> Presentations at appropriate conferences, such as the Critical Care Reviews (CCR) Annual Meeting; European Society of Intensive Care Medicine (ESICM) Annual Congress; Intensive Care Society (ICS) Annual Conference; British Association of Critical Care Nurses (BACCN) Annual Conference; the Case Mix Programme Annual Conference and Exhibition; and the Annual Meeting of the UK Critical Care Research Forum. It is anticipated that the findings will be presented from 2025 onwards.
The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
> Journals
> Conferences
> Study website
> Social media including the Study X/Twitter page and ICNARCs X/Twitter page. ICNARC has more than 10,000 followers which can be used to actively publicise progress with the research and disseminate the findings.
> The research team has strong links with the critical care community will help ensure that UK-ROX is at the forefront of the critical care communitys research agenda throughout the duration of the trial. This includes: the Faculty of Intensive Care Medicine (FICM), Intensive Care Society (ICS), British Association of Critical Care Nurses (BACCN), Royal College of Nursing Critical Care In-flight Nursing Forum (RC CCINF), NIHR Clinical Research Network Critical Care National Speciality Group and the UK Critical Care Research Group.
> One of the co-chief investigators on the trial is a member of the Academy of Medical Royal Colleges Academic Leads Committee.
> Professional societies concerned with the care of critically ill patients, including the ICS and FICM, provide them with evidence to inform future clinical guidelines arising from the research.
> Presentation slides and briefing papers will be prepared for use by the study team to disseminate the research findings.
Outputs are expected to be produced throughout 2025.
Processing:
ICNARC will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth and Postcode) and a unique person ID (UK-ROX Trial Number) for the cohort to be linked with NHS England data.
NHS England will provide the relevant records from the HES and mortality datasets to ICNARC. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.
ICNARC will securely transfer the Data to LSHTM. Some Data may be derived before data transfer, but the majority of the NHS England Data is required by LSHTM for their economic analysis.
The Data will be stored on servers provided by Exponential-E to ICNARC and at LSHTM.
ICNARC uses offsite back-up services provided by Exponential-E.
ICNARC also stores Data on the Cloud provided by Babble Cloud.
The Data will be accessed by authorised personnel via remote access.
The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.
For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisations DSPT (or other security arrangements as per this DSA) and complies with the organisations remote access policy.
The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).
The Data will not leave England and Wales at any time. Remote processing will be from secure locations within England/Wales.
Access is restricted to employees of ICNARC and LSHTM who have authorisation from the UK-ROX trial team.
All personnel accessing the Data have been appropriately trained in data protection and confidentiality.
The Data will be linked at person record level with the individual UK-ROX trial participant trial data, which contains details of oxygen and ventilation treatment in ICU (obtained from participating hospitals) and quality of life questionnaires completed by patients, using the UK-ROX trial number.
The UK-ROX trial team at ICNARC will additionally create a fully pseudonymised trial dataset which will be linked to both the pseudonymised mortality data, and the pseudonymised HES data from NHS England using the unique trial number field. The pseudonymised linked record level dataset will also be made available to the health economist, who is part of the UK-ROX trial team, based at the London School of Hygiene and Tropical Medicine (LSHTM) who will conduct the health economic evaluation.
The subsequent analyses will directly answer the trial research questions and achieve the purpose of finding out whether conservative oxygen therapy is superior to usual oxygen therapy, for the benefit of future NHS patients.
The Data will not be linked with any other data.
Access to patient identifiable data is restricted according to ICNARCs data access policies and procedures with access restricted to named individuals on a need-to-know basis, using auditable information systems.
Identifiable data will be anonymised within one year of the end of the study and the identifiers will be confidentially destroyed from all locations (ICNARC, Exponential-E). The dataset shared with LSHTM will contain no identifiers.
Analysts from ICNARC and LSHTM will analyse the Data for the purposes described above.
FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): A master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care — DARS-NIC-399287-T3X7W
Type of data: information not disclosed for TRE projects
Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 s261(2)(c)
Purposes: No (Research)
Sensitive: Sensitive, and Non Sensitive, and Non-Sensitive
When:DSA runs 2021-03-10 — 2024-03-09 2021.04 — 2023.08.
Access method: One-Off
Data-controller type: GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST, INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
Datasets:
- Civil Registration - Deaths
- Hospital Episode Statistics Admitted Patient Care
- Emergency Care Data Set (ECDS)
- Hospital Episode Statistics Outpatients
- Civil Registrations of Death
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Outpatients (HES OP)
Objectives:
FIRST-ABC is a master protocol of two pragmatic randomised clinical trials (RCTs) aiming to evaluate the clinical and cost-effectiveness of the use of High Flow Nasal Cannula (HFNC), as compared with Continuous Positive Airway Pressure (CPAP), when used as the first-line mode of non-invasive respiratory support in two distinct clinical scenarios:
1. in critically ill children requiring non-invasive respiratory support for an acute illness (step-up RCT); and
2. in critically ill children requiring non-invasive respiratory support within 72 hours of extubation following a period of invasive ventilation (step-down RCT).
Both HFNC and CPAP are currently routinely used across the NHS. This research is important to patients and the NHS because there is currently limited high-quality evidence to support whether HFNC or CPAP should be used as the first line mode of non-invasive respiratory support in critically ill children. In addition, previous research has also not studied the use of these interventions in the two distinct clinical scenarios outlined above. High quality evidence from RCTs is therefore urgently needed to help guide clinical decision making and to inform paediatric critical care clinicians and the wider NHS on the clinical and cost-effectiveness of HFNC versus CPAP – evidence which FIRST-ABC aims to provide.
FIRST-ABC is funded by the National Institute for Health Research (NIHR), Health Technology Assessment Programme. NIHR do not determine the purpose or the manner in which the data will be processed. FIRST-ABC is sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) and managed/coordinated by the Intensive Care National Audit & Research Centre (ICNARC). The health economic analysis will be completed by a health economist based at the London School of Hygiene and Tropical Medicine (LSHTM) on behalf of GOSH and ICNARC. FIRST-ABC aims to include a total of 1,200 children (600 in the step-down RCT and 600 in the step-up RCT, randomised to either HFNC or CPAP) from around 25 NHS paediatric critical care units across England, Wales and Scotland. NHS Digital data is requested for all cohort members who have had health events of interest within England and Wales.
Processing personal data is necessary for ICNARC's legitimate interests which are described in this agreement. The data to which access is requested are proportionate and necessary to achieve those interests. ICNARC has completed a legitimate interests assessment (LIA) and is satisfied that the interests of the data subjects do not override ICNARC’s 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.
The primary objective for processing NHS Digital data in this application is to provide important outcome data for FIRST-ABC. The outcomes for the trial are:
Primary outcome:
• Time to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free of all forms of respiratory support.
Secondary outcomes:
• Mortality at paediatric intensive care unit (PICU) / high dependency unit (HDU) discharge, day 60 and day 180
• Rate of (re)intubation at 48 hours
• Duration of PICU/HDU and hospital stay
• Patient comfort, during randomised treatment and during non-invasive respiratory support (i.e. HFNC and/or CPAP), assessed using the validated COMFORT-B score
• Proportion of patients in whom sedation is used during non-invasive respiratory support
• Parental stress, in hospital at the time of consent at/around 24-48 hours, measured using the Parental Stressor Scale: PICU
• Health-related quality of life (HrQoL) at six months using age-appropriate Pediatric Quality of Life Inventory (Peds-QL) and the Child Health Utility 9D (CHU-9D) questionnaires
Cost effectiveness analysis (CEA) outcomes:
• Total costs at six months
• Quality-adjusted life years (QALYs) at six months
• Incremental net monetary benefit gained at a willingness-to-pay of £20,000 per QALY at six months associated with HFNC versus CPAP
The following NHS Digital data will be processed: Mortality (date of death), and selected fields from Hospital Episode Statistics (HES) Admitted patient care (APC) and HES Outpatients (OP) datasets, and the Emergency Care Data Set (ECDS) - these data will be unsuppressed, pseudonymised and provided at record level. The data is required to be provided at record level as it will be linked to the individual FIRST-ABC Study participant trial data using the FIRST-ABC trial number.
Linking the FIRST-ABC data with HES and ECDS data from NHS Digital will contribute to the integrated economic evaluation to assess the cost-effectiveness of the first line use of HFNC versus CPAP. ICNARC have carefully reviewed the HES data dictionary to ensure that the data requested is the minimum required to meet the study objectives. Only those which are essential to meet the objectives of the research have been chosen. Specifically, HES OP, HES APC and ECDS data will be used to understand the economic impact of HFNC versus CPAP. Selected fields are those anticipated to drive potential differences in costs and resource utilisation between the groups and will be important in assessing the cost effectiveness of HFNC versus CPAP.
Patient dates of death (if applicable) are requested from NHS Digital to directly contribute to the clinical evaluation secondary outcome data (mortality at various time-points) (primary purpose). In addition, parents of trial participants are actively followed-up and sent a questionnaire by the FIRST-ABC trial team at ICNARC at six months post-randomisation. Given the nature of critical illness, unfortunately some participants will pass away during the trial follow-up period. Where the trial team learns that a participant has passed away, no contact will be made with parents - helping to ensure parents and relatives are not caused undue distress by no longer appropriate contact (secondary purpose).
In line with the timescales stated in the study outcomes, only six months of NHS Digital data will be requested for each study participant from their randomisation date (180 days from the date of randomisation). Both the step-down RCT and step-up RCT commenced patient recruitment in August 2019.
Recruitment for the step-down RCT finished in May 2020 and the final participant will have been in the trial for six months as of November 2020 (the final data collection timepoint for this cohort). Therefore, only data from years 2019/2020 and 2020/2021 is required for the step-down RCT cohort.
The recruitment period for the step-up RCT is planned to complete in January 2022 (given no delays) and subsequently the final patient in this cohort will have been in the trial for six months at the end of July 2022. Therefore, data from the following years will be needed for the step-up RCT cohort: 2019/2020, 2020/2021, 2021/2022 and 2022/2023.
The decision to initiate non-invasive respiratory support is most often made during a time-sensitive emergency situation, where any delay in commencing treatment could be detrimental to the patient and the scientific validity of the trial. This makes attempts to obtain fully informed prior consent from parents/legal guardians during such an emergency situation inappropriate and could cause additional stress to families who are already very distressed by their child’s critical illness. In addition, both modes of non-invasive respiratory support evaluated as first-line treatment in this study (CPAP and HFNC) are relatively safe, commonly used and in current clinical practice - only determined by individual clinician preferences. Considering these reasons, a deferred consent model (‘research without prior consent’) has been utilised in the FIRST-ABC Study, a model that has been found to be acceptable to parents/guardians as well as clinicians in several previous RCTs conducted in the paediatric critical care setting. This consent model has been informed and refined by extensive patient and public involvement (PPI) work and is based on the CONseNt methods in paediatric Emergency and urgent Care Trials (CONNECT) study guidance. The East of England – Cambridge South Research Ethics Committee - who are specifically flagged and expertly positioned to review research involving children in the NHS - has granted the use of the research without prior consent model to FIRST-ABC. All of the reasons outlined above demonstrate that there are no alternative, less intrusive ways of achieving the study purposes than linking FIRST-ABC data with NHS Digital data.
ICNARC is an independent health research charity which aims to help improve the quality of critical care through audit, research and education with, and in the interests of, patients and those who care for them. ICNARC requires data from NHS Digital for the purposes of these legitimate interests.
ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Specifically, data is processed under the following articles of the Data Protection Act 2018:
Article 6 (1) (f) Legitimate interests: the processing is necessary for your legitimate interests or the legitimate interests of a third party unless there is a good reason to protect the individual’s personal data which overrides those legitimate interests.
The data is required for a research project - and therefore ICNARC process the special category data (health data) under the following article of GDPR - Article 9 (2) (j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
Great Ormond Street Hospital for Children NHS Trust rely on Articles 6 (1) (e) – “public interest” and 9 (2) (j) – “scientific research” as the legal bases under GDPR.
The organisations involved in this application as follows: ICNARC – joint data controller, manages the study (as the Clinical Trials Unit), holds the study data and will conduct the primary analyses (i.e. a data controller who are also processing the data); Exponential-E are a contractor of ICNARC’s and provide the servers (including back-ups) on which data will be processed by ICNARC staff; London School of Hygiene and Tropical Medicine (LSHTM) is where the study health economist is based who will conduct the health economic analyses; Great Ormond Street Hospital for Children NHS Trust, as trial sponsor, is joint data controller but will not receive or process any trial data (including any data from NHS Digital). The trial management group includes members from the following organisations: Great Ormond Street Hospital for Children NHS Trust, University College London, Great Ormond Street Institute of Child Health, Birmingham Women's and Children's NHS Foundation Trust, University of Salford, University Hospitals Bristol NHS Foundation Trust, University of Leeds, LSHTM, and ICNARC. However, only ICNARC and LSHTM will receive and process study data.
Expected Benefits:
Nearly three-quarters of the 20,000 critically ill children admitted to UK paediatric intensive care units (PICUs) each year receive some form of respiratory support (invasive and/or non-invasive), making it the most common treatment provided in PICU. Both HFNC and CPAP are routinely used in NHS practice, but there is genuine uncertainty as to whether HFNC or CPAP should be used as the first line mode of non-invasive respiratory support in critically ill children in paediatric critical care units. It is not yet known whether HFNC is clinically and cost-effective, as compared to CPAP (this is what FIRST-ABC will tell us) but - it is anticipated that if either mode of non-invasive respiratory support 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 the delivery of respiratory support in paediatric critical care unit, ensuring first line use of non-invasive respiratory support is informed by robust and high quality randomised evidence. PICU beds are a highly valuable NHS resource, demand for which regularly outstrips supply, leading to delays in the provision of critical care to sick children.
It is anticipated that if HFNC is found to be clinically and cost-effective, implementation of these outputs into clinical guidelines and subsequently into the NHS will help accelerate its adoption in non-critical care areas, improve patient flow into and out of the PICU and promote more efficient utilisation of PICU beds. On the other hand, if HFNC was shown to be less effective and associated with longer PICU stay, this finding could also have profound implications for the optimal use of scarce NHS resources. The FIRST-ABC health economic evaluation will provide information on the cost-effectiveness of HFNC versus CPAP which will be used by policy makers, managers and clinicians in the NHS. All of the above will help to reduce the burden on patients, their carers and the NHS. This will need an effective implementation strategy.
Active and wide dissemination of the results of FIRST-ABC will be an important part of this strategy and will begin upon publication of the primary trial results (see ‘Specific outputs expected, including target date’ for further details). 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. Dissemination will be lead by the chief investigator working closely with ICNARC CTU and supported by other members of the trial management group. Dissemination of the step-down RCT results will commence in the second half of the 2021. Dissemination of the step-up RCT results will commence in early 2023.
In line with ICNARC’s legitimate interest of processing data for research and statistical purposes - the public (e.g. future critically ill paediatric patients) and the NHS will receive the benefits of the processing. Results of FIRST-ABC will help to guide paediatric critical care clinicians and the wider NHS on the clinical and cost-effectiveness of HFNC versus CPAP.
Outputs:
The results of FIRST-ABC will be both widely and actively disseminated. The research team has strong links with the PICU community via the Paediatric Intensive Care Society (PICS), PICS Study Group (PICS-SG), and the NIHR CRN: Children Clinical Studies Group (CSG) in Anaesthesia, Intensive Care and Cardiology, and similarly with the nursing community through the British Association of Critical Care Nurses (BACCN), the Royal College of Nursing Critical Care and In-flight Nursing Forum (RCN CCINF) and the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). The research team also has links with the Healthcare Quality Improvement Partnership national audit programme through the Paediatric Intensive Care Audit Network (PICANet).
The findings from our work will be presented at national and international conferences, potentially including the Annual Conference of the Royal College of Paediatrics and Child Health, the World Congress of Pediatric Intensive Care, PICS Annual Scientific Meeting, American Association of Pediatrics Conference, ESPNIC Annual Meeting, and British Association of Critical Care Nurses (BACCN).
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 in a high-impact, widely-read, open-access (where possible), general medical journal, such as the New England Journal of Medicine or the Journal of the American Medical Association.
The primary results of each RCT will be submitted for publication following the completion of recruitment and follow-up (anticipated to be January 2022 for the step-down RCT and January 2023 for the step-up RCT). The NIHR report will be submitted for publication in January 2023. We would anticipate publication of results within six months of these submission dates.
Evidence to inform future clinical guidelines arising out of the research will be published and disseminated to professional societies concerned with the care of children presenting with acute illness, including PICS and the Royal College of Paediatrics and Child Health. Presentation slides will be prepared for use by the study team or others in disseminating the research findings.
The results of the study will be disseminated to patients and their families, facilitated by the co-applicants, members of the research team who have links with PICS and the NIHR CSG, and via Family Groups we have liaised with already. The FIRST-ABC research team has worked closely with patient representatives throughout the study conduct. Two parents of children who received breathing support are co-applicants on FIRST-ABC grant application and have actively contributed to the study design and procedures, including the use of deferred consent as well as the development of study documents (for example, Patient Information Sheets). The Trial Management Group and the Trial Steering Committee include Patient and Public Involvement representatives as members. These collaborations will continue to ensure dissemination of the results to patients and the public.
A study website and posts on ICNARC’s social media accounts (ICNARC has more than 7,000 followers on Twitter) will also be utilised to actively publicise progress with the research and disseminate our findings.
In addition to disseminating the results to patients and their families - this dissemination plan will ensure that the results of FIRST-ABC 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 FIRST-ABC to influence clinical practice for the benefit of critically ill patients.
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.
The FIRST-ABC protocol has been published in British Medical Journal (BMJ) Open and the statistical analysis plan has been published in Trials (please see the references below).
Richards-Belle A, et al. FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care. BMJ Open. 2020 Aug 4;10(8):e038002. doi: 10.1136/bmjopen-2020-038002.
Orzechowska, I., Sadique, M.Z., Thomas, K. et al. First-line support for assistance in breathing in children: statistical and health economic analysis plan for the FIRST-ABC trial. Trials 21, 903 (2020). https://doi.org/10.1186/s13063-020-04818-w
Processing:
For consented participants discharged alive from hospital for the admission from which they were recruited into the FIRST-ABC study, data from NHS Digital are requested to contribute to the analysis of the study outcomes, alongside separate trial data collected from hospital records at participating sites, and reported outcomes from the participants themselves.
To obtain pseudonymised record level HES APC, HES OP, ECDS and Civil Registration (Deaths) data from NHS Digital, an authorised member of the FIRST-ABC Study team at the ICNARC CTU will provide identifiable record level data on a spreadsheet to NHS Digital via Secure Electronic File Transfer on two separate occasions. These spreadsheets will contain the following data fields: FIRST-ABC Trial number, date of randomisation (start date for calculating the six-month follow-up period), full name, date of birth, NHS number and postcode.
Cohort data retrieval from NHS Digital will occur at two time points. Cohort data retrieval number one is for the step-down RCT cohort. This will occur upon the sign off of the data sharing agreement. This cohort will contain maximum of 600 patients (participants who passed away in hospital, declined or withdrawn consent will not be submitted). Patients in this cohort were recruited between August 2019 and May 2020. The final participant will have been in the trial for six months as of November 2020 (the final data collection timepoint for this cohort). Therefore, to ensure each participant has six months of HES/ECDS data, data from years 2019/2020 and 2020/2021 are required for the step-down RCT cohort. Civil Registrations (Deaths) data will be provided at the same time as HES/ECDS data.
Cohort data retrieval number two is for the step-up RCT cohort. This will occur once the last patient recruited in this cohort will have been in the trial for six months. This cohort will contain maximum of 600 patients (participants who passed away in hospital, declined or withdrawn consent will not be submitted). The recruitment commenced in August 2019 and is anticipated to complete in January 2022 (given no delays). This will mean that the final patient in this cohort will have been in the trial for six months at the end of July 2022. Therefore, to ensure each participant has six months of HES/ECDS data, data from years 2019/2020, 2020/2021, 2021/2022 and 2022/2023 are required for the step-up RCT cohort. Civil Registrations (Deaths) will be provided approximately 6 weeks after the final patient follow-up date.
Members of the FIRST-ABC Study team at ICNARC will access the trial data and NHS Digital data via secure ICNARC databases, including using a VPN connection when working remotely. Remote access is required in line with national UK Government guidance during the COVID-19 pandemic to work from home wherever feasible. All members of the ICNARC FIRST-ABC Study team work on ICNARC-provided devices that are password protected and encrypted to the secure standard required by the UK regulator for data protection. All study data are stored in databases or folders where access is restricted to authorised essential members of the FIRST-ABC study team only. The data is held on secure servers provided by Exponential-E. ICNARC will also regularly back-up the data through Exponential-E. Exponential-E is an IT contractor authorised by ICNARC with ISO 27001 security assurances in place.
A small number of named members in the FIRST-ABC study team at ICNARC will link up the identifiable trial data with the mortality status and date of death (where applicable) from the Civil Registrations (Deaths) file provided by NHS Digital. This is in line with reasonable expectations of the parents of trial participants, as outlined in ‘Objectives for Processing’.
The FIRST-ABC study team at ICNARC will additionally create a fully pseudonymised trial dataset which will be linked to both the pseudonymised deaths data, and the pseudonymised HES/ ECDS data from NHS Digital using the unique trial number field. Linking the FIRST-ABC trial data with the NHS Digital data will allow ICNARC to complete analysis of mortality at various time points – one of the secondary outcomes of the study. The pseudonymised linked record level dataset will also be made available to the health economist, who is part of the FIRST-ABC study team, based at the London School of Hygiene and Tropical Medicine (LSHTM) who will conduct the health economic evaluation.
To minimise the risk of re-identification of study participants, the pseudonymisation process for the trial data will include the following: allocated trial numbers and site codes will be replaced by new identifiers, the link between actual trial numbers/site code will be held securely by ICNARC and not shared with LSHTM; Date of birth will be used to calculate calendar age (in months and/or years) at randomisation, only calculated age and not date of birth will be shared with LSHTM; All dates of any events post-randomisation (including hospital discharge and death) will be removed from the dataset and replaced by calculated fields indicating the elapsed time from randomisation; Date of randomisation will not be included. The same method will be used to remove dates of any pre-randomization events. All free text fields will either be removed from the dataset before transfer, or individual entries will be checked and any identifiable information (including patient, staff or hospital names) will be removed. The subsequent analyses will directly answer the trial research questions and achieve the purpose of finding out whether HFNC is non-inferior to CPAP for the benefit of future NHS patients.
The data is held on secure servers at LSHTM. Data will be stored in an on-site data safe and data will only be accessed by authorised individuals within LSHTM. There will be no requirement or attempt by the team at LSHTM to reidentify individuals. All data processing will only be carried out by substantive employees of named data controllers and processors who have been appropriately trained in data protection and confidentiality. The essential members of the study team at LSHTM will access the data through a secure link via designated LSHTM password protected computer whilst working from home. The data will be stored in a folder where access is restricted to essential members of the study team only. Remote access is required in line with national UK Government guidance during the COVID-19 pandemic to work from home wherever feasible.
MR1467 - The 65 Trial: Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension — DARS-NIC-96444-N2B7K
Type of data: information not disclosed for TRE projects
Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Reasonable Expectation, Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 – s261(7), Other - Health and Social Care Act 2012 - s261(1) and s261(2)(c), Other-Health and Social Care Act 2012 - s261(1) and s261(2)(c), Health and Social Care Act 2012 s261(2)(c)
Purposes: No (Research)
Sensitive: Sensitive
When:DSA runs 2019-07-01 — 2022-06-30 2018.06 — 2019.08.
Access method: Ongoing, One-Off
Data-controller type: INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
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.
Yielded Benefits:
The 65 Trial completed patient recruitment in March 2019 and follow-up is ongoing. Following completion of data collection, the database will be locked, analysis conducted and papers/reports prepared for publication in high impact peer reviewed medical journals (according to the timeline outlined previously). The protocol for the 65 Trial, along with the Statistical Analysis Plan, were both accepted for publication the Journal of the Intensive Care Society in March 2019 and are anticipated to be published in the coming months.
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).
Renal Replacement Anticoagulant Management (RRAM) — DARS-NIC-184951-D1G8R
Type of data: information not disclosed for TRE projects
Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, 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), Health and Social Care Act 2012 s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Purposes: No (Research)
Sensitive: Non Sensitive, and Non-Sensitive, and Sensitive
When:DSA runs 2018-12-03 — 2021-12-02 2019.02 — 2019.02.
Access method: One-Off
Data-controller type: INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
Datasets:
- Civil Registration - Deaths
- Hospital Episode Statistics Admitted Patient Care
- Civil Registration (Deaths) - Secondary Care Cut
- Civil Registrations of Death - Secondary Care Cut
- Hospital Episode Statistics Admitted Patient Care (HES APC)
Objectives:
The Renal Replacement Anticoagulation Management (RRAM) study is an observational study that has been designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU).
This research is important to patients and the NHS as there is currently a rapid change occurring within the NHS, whereby traditional heparin based anticoagulation for CRRT is being replaced by citrate based methods. This is being done without any evidence that citrate is superior to heparin in terms of clinical or cost-effectiveness. This study will make the most of an efficient design using available data to clarify the effect of changing to citrate-based anticoagulation on health and economic outcomes in normal clinical practice to help determine whether the change should be encouraged or stopped.
The RRAM study is funded by the National Institute for Health Research, Health Technology Assessment Programme (HTA 16/111/136), is managed and sponsored by the Intensive Care National Audit & Research Centre (ICNARC) and will include data from approximately 85,000 patients that were admitted to an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017.
The chief investigator for this NIHR funded study is from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities are to co-ordinate the study and will be providing data for the health economics aspect of the study. This will be completed separately to the data linkage and analysis described in this application which will take place at ICNARC only. Oxford will not have access to data provided by NHS Digital data.
The “legitimate interests” relied upon are of healthcare research. This is because the data processing described here is to support scientific and statistical research.
ICNARC has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. 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 and has been reviewed by NHS Digital.
Purpose Test: are you pursuing a legitimate interest? ICNARC is an independent charity committed to providing high quality information through their national clinical audits, where hospitals/critical care units use information from reports to help them improve care; through research, where data are collected to answer specific questions or to test theories.
Necessity Test: is the processing necessary for that purpose? 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.
Balancing Test: do the individual’s interests override the legitimate interest? 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.
The primary outcome for the processing of NHS Digital data in this application is to provide important outcome data for this study. The outcomes of the study are:
Primary outcomes:
• All cause mortality at 90 days (clinical effectiveness)
• Incremental net monetary benefit at 1 year (cost effectiveness)
Secondary outcomes:
• All-cause mortality at hospital discharge, 30 days and one year
• Days of renal, cardiovascular, and advanced respiratory support
• ICU and hospital length of stay
• New dialysis-dependent renal disease at one year
• Estimated lifetime incremental cost-effectiveness
ICNARC are requesting linked data for a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients will be identified using the following inclusion criteria: aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and in receipt of CRRT for at least one calendar day during the ICU stay. It is estimated that 85,000 patients would be included within the project.
ICNARC are requesting patient status (i.e. dead, alive, unknown/unable to link) and date of death (where applicable) from NHS digital via linkage to Civil Registration death data for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the secondary outcomes of all-cause mortality at 30 days and one year.
In addition, ICNARC are requesting linkage to HES inpatient data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness.
NHS Digital will also perform third party linkage to the UK Renal Registry (UKRR) for all patients in the cohort to identify diagnosis of new dialysis-dependent renal disease. The UKRR are not considered a data processor as they are only supplying direct patient identifiers to NHS Digital for data linkage and will not receive any HES/Civil Registration death data for linked patients.
Expected Benefits:
The RRAM study aims to determine the clinical and cost-effectiveness of regional citrate anticoagulation (RCA) versus systemic heparin anticoagulation (SHA) for continuous renal replacement therapy (CRRT) in patients treated in an ICU. Currently there is a rapid shift towards the use of RCA for CRRT amongst NHS hospitals, however there is little evidence that it is superior to SHA in terms of clinical outcomes and cost-effectiveness.
The benefits to the NHS may be very large. ICNARC estimate these results will apply directly to 95% of UK intensive care units (ICUs) who between them treat 17,000 patients per year for acute kidney injury with about 190,000 patient-days of continuous renal replacement therapy (CRRT) delivered at an estimated cost of £1000-£1200 per patient-day.
The study will provide the first accurate cost-effectiveness analysis of regional citrate anticoagulation (RCA) and systemic heparin anticoagulation (SHA) in the NHS. If the results show that RCA is less effective and more costly than SHA, curbing the spread of RCA will benefit both patients and NHS funds. In contrast, if RCA is more effective and less costly both patients and the NHS will benefit from a more effective, cheaper treatment. However, it is more likely RCA is either less effective and less costly, or more effective and more costly. In this case the benefits to the NHS budget and the patient benefit go in different directions and the overall benefit depends on willingness to pay for clinical benefit.
Both patients and the NHS will benefit from identifying the best mode of anticoagulant treatment for CRRT in patients in the ICU. If neither treatment is clinically superior, benefits will be gained by identifying which treatment is most cost-effective when considering hospitalisations.
This will need an effective implementation strategy. Active and wide dissemination of the results of the RRAM study will be an important part of this strategy and will begin upon publication of the primary study results (estimated to be published around September 2019). 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 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 Technology Assessment programme. Target date for submission is 30/06/2019. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.
2. The results of the study will be published in a peer reviewed journal and will conform to the RECORD standards – an agreed set of ‘rules’ for reporting research studies based on routinely-collected data. Target date for submission: September 2019. However, given the large amount of work planned within each area of the study it may be appropriate to split the data into more than one article. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.
3. Presentations at professional and scientific conferences, including the Annual Meeting of the Case Mix Programme (April 2019), the annual UK Kidney Week meet meeting (May 2019), and the UK Intensive Care Society (ICS) State of the Art Meeting (December 2019). Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.
4. The final linked pseudonymised dataset will be retained and stored securely on ICNARC’s servers for 5 years. Any requests for additional analyses based on this dataset would be subject to an amendment to this agreement and approval by NHS Digital.
5. 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 our Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The RRAM team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the study 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).
Processing:
In summary ICNARC are requesting three data linkages:
1. Patient status/date of death via linkage to Civil Registration data for all patient in the CMP.
2. Linkage to the HES APC data for all patients in the CMP.
3. NHS Digital to carry out third party linkage to the UKRR data for all patients who match in the CMP. The study id only will be returned to UKRR and UKRR will send the clinical data to ICNARC. ICNARC will used the study id to link the returned HES and Civil Registration data and UKRR data to the relevant clinical data from the CMP database to create a final dataset for analysis.
NHS Digital will link direct patient identifiers provided from the CMP by ICNARC to HES, Civil Registration and UKRR datasets.
The data linkage will process as follows:
1. ICNARC will identify eligible patients from the CMP database between 1 April 2009 and 31 March 2017 and will upload to NHS Digital a file containing a study ID (for identification in the CMP) and the following direct patient identifiers; NHS number, date of birth and postcode.
2. In parallel, UKRR will provide NHS Digital with a file containing the same direct patient identifiers for patients in the UKRR between 1 April 2009 and 31 March 2017 plus a local UKRR ID. The local ID will allow for linkage back to the locally held audit data.
The transfer of direct patient identifiers from ICNARC and the UKRR to NHS Digital is covered by the Section 251 approval (18/CAG/0070) for the RRAM study.
3. NHS Digital will match direct patient identifiers from the CMP with those supplied from the UKRR and return to ICNARC and the UKRR a linkage file containing the local ID (to the UKRR) and study ID (allowing for linkage across all the datasets) for all matched records. NHS Digital will also perform linkage for all patients within the CMP to HES (containing information on hospitals admissions for all matched patients between CMP and HES datasets) and Civil Registration (deaths) (containing death data for all matched patients between the CMP and Civil Registration) datasets.
The local ID will be used by the UKRR to identify the relevant records within their individual audit system when it is returned by NHS Digital along with a study ID. This means that the UKRR will not receive any data other than the two ID’s. For the ICNARC CMP, the study ID will act as the local ID.
4. The UKRR will then provide ICNARC a file containing the clinical fields (with no direct patient identifiers) required for the project along with the study ID for those patients identified in the CMP. In parallel, NHS Digital will provide ICNARC a file containing agreed HES (containing information on hospitals admissions for all matched patients between CMP and HES datasets) and Civil Registration (deaths) (containing mortality data or all matched patients between the CMP and Civil Registration dataset (deaths)) data together with the study ID for patients identified in the ICNARC CMP.
5. ICNARC will use the study ID to link the data extracts provided by the UKRR and NHS Digital with the relevant clinical data from the ICNARC CMP to create the final dataset. Once the data are linked, ICNARC will pseudonymise the dataset by replacing date of birth with age in years, replacing the date of admission to critical care unit with 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 postcode with area level deprivation measures, and replacing hospital/critical care unit names with anonymous identifiers. Consequently, the final pseudonymised dataset will contain no patient identifiable data.
6. The final linked project dataset will be analysed by statisticians at ICNARC, all of whom are substantive employees. The analysis will follow interrupted time series analysis techniques to compare the clinical effectiveness of a change to citrate anticoagulation on; all-cause mortality at 90-days, 30-days, and one year; number of days receiving renal, cardiovascular, and advanced respiratory support; ICU length of stay; and development of new-dialysis renal disease at one year.
In summary ICNARC are requesting three data linkages:
1. Patient status/date of death via linkage to Civil Registration data for all patient in the CMP.
2. Linkage to the HES APC data for all patients in the CMP.
3. NHS Digital to carry out third party linkage to the UKRR data for all patients who match in the CMP. The study id only will be returned to UKRR and UKRR will send the clinical data to ICNARC. ICNARC will used the study id to link the returned HES and Civil Registration data and UKRR data to the relevant clinical data from the CMP database to create a final dataset for analysis.
The data received from NHS Digital will be incorporated into the RRAM study 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.
Future linkage to the Patient Episode Database for Wales (PEDW) will take place in order to obtain inpatient data for patients treated in Welsh hospitals. This linkage will be performed separately to the NHS Digital linkage described above. This linkage will not involve the transfer of UKRR or NHS Digital data away from ICNARC.
NHS Digital reminds all organisations party to this agreement of the need to 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).
MR1436 - Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial — DARS-NIC-46844-W5V5G
Type of data: information not disclosed for TRE projects
Opt outs honoured: N, Identifiable (Consent (Reasonable Expectation))
Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 s261(2)(c)
Purposes: No (Research)
Sensitive: Sensitive
When:DSA runs 2019-08-01 — 2022-07-31 2017.09 — 2018.02.
Access method: Ongoing, One-Off
Data-controller type: INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
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
Yielded Benefits:
The POPPI Trial database is now locked and primary dissemination of the trial results is ongoing. As indicated in the Outputs section, yielded benefits to date have included: Publication of the clinical and cost-effectiveness results in the Journal of the American Medical Association (JAMA) Submission of the Final Report to the National Institute for Health Research (NIHR) Health Services and Delivery Research Programme The Trial Protocol and Statistical and Health Economic Analysis Plan have been published for public benefit. Presentations at national and international conferences have been given to present the research and preliminary results.
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.
Risk modelling in the critically ill — DARS-NIC-379807-P3R7Z
Type of data: information not disclosed for TRE projects
Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Identifiable (Section 251, Section 251 NHS Act 2006, Does not include the flow of confidential data)
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), Health and Social Care Act 2012 s261(1) and s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 s261(2)(b)(ii), Health and Social Care Act 2012 s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 s261(2)(a)
Purposes: No (Research)
Sensitive: Sensitive, and Non Sensitive, and Non-Sensitive
When:DSA runs 2019-07-23 — 2020-01-31 2018.06 — 2016.11.
Access method: Ongoing, One-Off
Data-controller type: INTENSIVE CARE NATIONAL AUDIT & RESEARCH CENTRE (ICNARC)
Sublicensing allowed: No
Datasets:
- Hospital Episode Statistics Admitted Patient Care
- Civil Registration - Deaths
- HES:Civil Registration (Deaths) bridge
- Office for National Statistics Mortality Data
- Civil Registration (Deaths) - Secondary Care Cut
- National Diabetes Audit
- Civil Registrations of Death - Secondary Care Cut
- Hospital Episode Statistics Admitted Patient Care (HES APC)
Objectives:
The renewal request is due to the organisation not yet receiving the final linked study dataset due to delays in approvals and in preparation of the required cohorts of data.
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 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.
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.
Expected Benefits:
Adult general critical care data 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: 15/01/2019. 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: January to March 2019. 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 ICNARC Annual Conference (April 2019), the Annual Meeting of the National Cardiac Arrest Audit (November 2019) and the Annual Congress of the European Society of Intensive Care Medicine (October 2019). 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 NHS Digital. Any such permission for the onward sharing of record level data would be subject to a future application.
Processing:
All those with access to the data are substantive employees of ICNARC.
All processing of ONS data will be in line with ONS standard conditions.
All outputs will be restricted to aggregate data with small numbers supressed in line with the HES analysis guide.
The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement.
NHS Digital 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 NHS Digital's secure file sharing platform datasets consisting of the available identifiers for patients included in each national clinical audit together with a local key permitting linkage back to locally held data for the audit.
NHS Digital 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 NHS Digital 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. NHS Digital 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 NHS Digital 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 which 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). All those with access to the data are substantive employees of ICNARC. 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.
The reason for requesting historical data is for analysis of co-morbidity, to look back at previous admissions and prior use of healthcare, which is a predictor of subsequent use.
NHS Digital reminds all organisations party to this agreement of the need to 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).
The legal bases for processing data under GDPR are Article 6(1)(f) - legitimate interest - and Article 9(2)(j) - Scientific research. The ICO checklist and a Legitimate Interest Assessment have been completed which confirm that the three tests are met and legitimate interest is the most appropriate legal basis as the organisation is a charity processing patient data to conduct scientific research in the public interest.