HES/ONS data for the AIRWAYS-2 cluster randomised trial.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

Pre hospital Pre-hospital cardiac arrest is a common cause of death in the UK, with only approximately 10% of patients surviving to hospital discharge. During a cardiac arrest, the brain and other organs can become deprived of oxygen which can result in death or survival with cognitive deficits. These cognitive deficits are still seen in up to half of the survivors even six months after the arrest. During a cardiac arrest, the brain and other organs can become deprived of oxygen which can result in death or survival with cognitive deficits. These cognitive deficits are still seen in up to half of the survivors even six months after the arrest. Traditional teaching suggests that tracheal intubation (intubation with a tube) is the best way to manage the airway during out of hospital cardiac arrest (OHCA). However, In 2008 the Joint Royal Colleges Ambulance Liaison Committee recommend the use of Supraglottic airway devices (SADs) as an alternative to intubation. This study, which is being coordinated by University Hospitals Bristol NHS Foundation Trust, tests the hypothesis that the supra-gottic airway device (SAD) is superior to the conventional treatment of tracheal intubation (TI). Traditional teaching suggests that tracheal intubation (intubation with a tube) is the best way to manage the airway during out of hospital cardiac arrest (OHCA). The study aims to establish the most effective method available to ambulance staff that enables the restoration of breathing in patients who have had an out of hospital cardiac arrest (OHCA) in terms of both clinical and cost effectiveness. Data provided by NHS Digital will be used as part of a research project which will provide the NHS with evidence of how best to treat out of hospital cardiac arrests (OHCA). In 2008, the Joint Royal Colleges Ambulance Liaison Committee recommend the use of Supraglottic airway devices (SADs) as an alternative to intubation. The study team are undertaking a large randomised controlled trial (RCT) in four English NHS ambulance services (South Western Ambulance Service NHS Foundation Trust (SWAST), Yorkshire Ambulance Service NHS Trust (YAS), East of England Ambulance Service NHS Trust (EAST) and East Midlands Ambulance Service NHS Trust (EMAS)) and 100 hospitals to determine whether placing a breathing tube in the windpipe (intubation) or the best available supraglottic airway device (called the i-gel) gives the best chance of recovery following OHCA. For ethical reasons, there is no control group which did not have an intervention. The study team are following up patients for 6 months after OHCA to find out the quality of life of survivors and the NHS resources used. This study which is being coordinated by University Hospitals Bristol NHS Foundation tests the hypothesis that the supra-gottic airway device (SAD) is superior to the conventional treatment of tracheal intubation. The study team will use Civil Registry data and HES Admitted Patient Care, Critical Care, A&E and Outpatient data to capture secondary care resource use and deaths that occur after OHCA during study follow up. Patients will be followed up in hospital, and 3 and 6 months later, to find out the quality of life of survivors and the NHS resources used during their hospital stay and subsequently. Patient confidential data will be obtained from the ambulance service regarding OHCA patients who are initially admitted to hospital alive. Personal identifying information from survivors will be used for verifying survival status with NHS Digital. The study aims to establish the most effective method by ambulance staff to restore breathing in patients who have had an out of hospital cardiac arrest (OHCA) in terms of both clinical and cost effectiveness. Data provided by NHS Digital will be used as part of a research project which will provide the NHS with evidence of how best to treat out of hospital cardiac arrests (OHCA). The study team are undertaking a large randomised controlled trial (RCT) in four English NHS ambulance services and 100 hospitals to determine whether placing a breathing tube in the windpipe (intubation) or the best available supraglottic airway device (called the i-gel) gives the best chance of recovery following OHCA. There is no control group which did not have an intervention. The four English NHS ambulance services involved are South Western Ambulance Service NHS Foundation Trust (SWAST), Yorkshire Ambulance Service NHS Trust (YAS), East of England Ambulance Service NHS Trust (EAST) and East Midlands Ambulance Service NHS Trust (EMAS). The study team are following up recruited patients for 6 months after OHCA to find out the quality of life of survivors and the NHS resources used. The study team will use Civil Registry data and HES/ONS Admitted Patient Care, Critical Care , Accident and Emergency and Outpatient data to capture secondary care resource use and deaths that occur after OHCA during study follow up. Patients will be followed up in hospital, and 3 and 6 months later, to find out the quality of life of survivors and the NHS resources used during their hospital stay and subsequently. Patient confidential data will be obtained from the ambulance service regarding OHCA patients who are initially admitted to hospital alive. Personal identifying information from survivors will be used for verifying survival status with NHS Digital. [5 paragraphs unchanged] One of the main objectives of the study study, in line with the NIHR objective objectives, is to estimate the cost effectiveness of the trial interventions; HES and [67 words unchanged] to 6 months. Costs and QALYs will be summarised by trial group. Data is being processed until under General Data Protection Regulation (GDPR, 2018) Article 6(1)(e). 6(1)(e) and Article 9(2)(j) as a task in the public interest, as part of an NIHR funded ethically approved clinical trial. This is a task in the public interest as processing is necessary for scientific research purposes. Processing is required in order to complete analyses for a NIHR funded [97 words unchanged] in England. The dissemination is part of an ethically approved clinical trial. [1 paragraph unchanged] HES and Civil Registry data provided by NHS Digital was linked to trial data collected by the Clinical Trials and Evaluation Unit, University Hospitals Bristol and Weston NHS Foundation Trust. University Hospitals Bristol and Weston NHS Foundation Trust share the linked data with the health economists at [35 words unchanged] of Oxford via encrypted email. The co-ordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust provide the health economists in Oxford with the document [24 words unchanged] for NHSmail, HSCIC’ was followed. The coordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust used an NHS.net email account to send the data [36 words unchanged] At no point will the health economists have access to patient identifiable data.’ data. University Hospitals Bristol NHS Foundation Trust hold the study cohort. Patient identifiers were provided to NHS Digital by University Hospitals Bristol NHS Foundation Trust. Linked data then flowed back from NHS Digital to University Hospitals Bristol NHS Foundation Trust. This data was pseudonymised by University Hospitals Bristol NHS Foundation Trust and sent to the health economists at the Nuffield Department of Population Health, University of Oxford via encrypted email. The process for this is explained in current section 5b. The trial is being sponsored by South Western Ambulance Services NHS Foundation Trust, and is funded by the NIHR (12/167/102) under the NIHR Health Technology Assessment Award. The trial is being sponsored by South Western Ambulance Services NHS Foundation Trust. South Western Ambulance Services NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust and the University of Oxford are joint data controllers. The University of Oxford and University Hospitals Bristol and Weston NHS Foundation Trust will act as joint data processors. Substantive employees of the University of Bristol will be processing the data under honorary contract as agents of the University Hospitals Bristol and Weston NHS Foundation Trust. No other organisation is or will be processing the data for the purpose described in this Agreement. South Western Ambulance Services NHS Foundation Trust, University Hospitals Bristol NHS Foundation Trust and the University of Oxford are joint data controllers. The University of Oxford and University Hospitals Bristol NHS Foundation Trust will act as joint data processors. Substantive employees of the University of Bristol will be processing the data under honorary contract as agents of the University Hospitals Bristol NHS Foundation Trust. No other organisation is or will be processing the data for the purpose described in this Agreement. South Western Ambulance Service NHS Foundation Trust (SWAST) hold the contract with the Department of Health for the study, but will have no access to the record level data. South Western Ambulance Service NHS Foundation Trust hold the contract with the DH for the study. SWAS NHS Trust will have no access to the record level data. University of Oxford will have access to the pseudonymised record level data University Hospital Bristol NHS Foundation Trust will have access to the record level data with identifiers. [1 paragraph unchanged] This study has been funded by the NIHR (12/167/102) under the NIHR Health Technology Assessment Award.

Processing activities

University Hospitals Bristol NHS Foundation Trust sent patient identifiable data (Study ID, NHS Number, Date of Birth, Surname, Forename, Gender, Postcode) to NHS Digital. HES and Civil Registry data was returned by NHS Digital to University Hospitals Bristol NHS Foundation Trust. The coordinating centre at University Hospitals Bristol NHS Foundation Trust are undertaking 4 main tasks using the HES and Civil Registry data: (1) Check the degree of successful linkage with HES and, if low, explore patterns in the AIRWAYS-2 data set that might explain this, (2) Cross check the length of ICU stay and hospital stay with the information collected on the AIRWAYS-2 data collection forms, including filling in any missing data which can be ascertained from HES, 3) Cross-check and update the survival status of all patients, regardless of consent status, where missing. These outcomes (from tasks 2 and 3) are analysed and reported by the Bristol team. (4) Code relevant AIRWAYS-2 trial data to the HES records ready for the health economic analysis to proceed. Following these tasks, the coordinating centre at University Hospitals Bristol NHS Foundation Trust pseudonymise the linked data by removing patient identifying information, leaving only the study ID and data items requested, and transfer pseudonymised data on all patients via encrypted email to health economists at the Nuffield Department of Population Health (NDPH) at the University of Oxford for analysis. University Hospitals Bristol and Weston NHS Foundation Trust sent patient identifiable data (Study ID, NHS Number, Date of Birth, Surname, Forename, Gender, Postcode) to NHS Digital. Identifiable HES and Civil Registry data was returned by NHS Digital to University Hospitals Bristol and Weston NHS Foundation Trust. Under this Agreement there will be a re-supply of HES Critical Care data with revised data minimisation criteria that should better meet the needs of University Hospitals Bristol and Weston NHS Foundation Trust. The coordinating centre at University Hospitals Bristol NHS Foundation Trust provide the health economists in Oxford with the document ‘Accessing Encrypted Emails Guide for Non-NHSmail users, HSCIC’, and the health economists have registered for the encryption service. Guidance in the document ‘Encryption Guide for NHSmail, HSCIC’ was followed. The coordinating centre at University Hospitals Bristol NHS Foundation Trust used an NHS.net email account to send the data via encrypted email to the health economists in Oxford. The data attached to the email will is also be password protected. The coordinating centre in Bristol provide the password to the health economists in Oxford via telephone. At no point will the health economists have access to patient identifiable data. SWAST will have oversight of the processes in their role of Sponsor. At no point will SWAST have access to any record level data - they will only see the aggregated outputs with small numbers suppressed in line with the HES analysis guidelines. No patients will be identified in any study outputs. The coordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust are undertaking 4 main tasks using the HES and Civil Registry data: (1) Check the degree of successful linkage with HES and, if low, explore patterns in the AIRWAYS-2 data set that might explain this, (2) Cross check the length of ICU stay and hospital stay with the information collected on the AIRWAYS-2 data collection forms, including filling in any missing data which can be ascertained from HES, (3) Cross-check and update the survival status of all patients, regardless of consent status, where missing. These outcomes (from tasks 2 and 3) are analysed and reported by the Bristol team. (4) Code relevant AIRWAYS-2 trial data to the HES records ready for the health economic analysis to proceed. Patient identifiable data for AIRWAY-2 patients was sent to NHS Digital along with each patients' unique study ID, in order that HES and Civil Registry data for these patients could be sent back, with a unique study ID together with patient identifying information and relevant data items from HES and the Civil Registry. All data received by University Hospital Bristol and Weston (UHBW) are stored on NHS computers based on the UHBW site. All computers are password protected, and access is restricted to those who are processing NHS Digital data for the purposes described within this Agreement. These data will be linked to the trial data by the team named at CTEU Bristol. The dataset (including HES and ONS Civil Registry mortality data) will be validated before being pseudonymised for transfer to the health economists at the Nuffield Department of Population Health at University of Oxford. Substantive employees of the University of Bristol will be processing the data under honorary contracts as agents of the University Hospitals Bristol and Weston NHS Foundation Trust, all of whom will be trained in data protection and confidentiality. Following these tasks, the coordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust pseudonymise the linked data by removing patient identifying information, leaving only the study ID and data items requested, and transfer pseudonymised data on all patients via encrypted email to health economists at the Nuffield Department of Population Health (NDPH) at the University of Oxford for analysis. There will be no attempt made to re-identify individuals following pseudonymisation. The trial aims to determine whether the i-gel is superior to tracheal intubation in non-traumatic OHCA in adults, in terms of both clinical and cost effectiveness. The coordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust provide the health economists in Oxford with the document ‘Accessing Encrypted Emails Guide for Non-NHSmail users, HSCIC’, and the health economists have registered for the encryption service. Guidance in the document ‘Encryption Guide for NHSmail, HSCIC’ was followed. The coordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust used an NHS.net email account to send the data via encrypted email to the health economists in Oxford. The data attached to the email will is also be password protected. The coordinating centre in Bristol provide the password to the health economists in Oxford via telephone. One of the secondary outcome measures is mortality; the ONS Civil Registry data will be used to assist in the estimation of the difference in mortality between groups. Those patients who are deceased upon arrival at hospital are included within the study. At no point will the health economists have access to identifiable patient data. SWAST will have oversight of the processes in their role of Sponsor. At no point will SWAST have access to any record level data - they will only see the aggregated outputs with small numbers suppressed in line with the HES analysis guidelines. The data received under this agreement will be linked to the trial data by the team named at Clinical Trials Evaluation Unit (CTEU) Bristol. Other than linkages already described within this Agreement, there will be no additional linkage of data. The data controllers are responsible for the activities of all individuals (“Individuals”) who have access to the patient data disseminated by NHS Digital ("Data") and are engaged by any data controller or data processor listed in this agreement, regardless of whether such Individual is described as an employee, contractor, secondee, PhD or post-doctoral student or honorary employee. [1 paragraph unchanged] South Western Ambulance Service NHS Foundation Trust and the University of Bristol will not have access to any of the data as a processor and will only see aggregated outputs with small numbers suppressed. There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement. The data controllers are responsible for the activities of all individuals (“Individuals”) who have access to the patient data disseminated by NHS Digital ("Data") and are engaged by any data controller or data processor listed in this agreement, regardless of whether such Individual is described as an employee, contractor, secondee, PhD or post-doctoral student or honorary employee.

Expected output

- Study primary outcome paper: Published August 2018 - Report to funding body (HTA): Due October 2019 - Long-term and secondary outcomes paper: Published in Resuscitation December 2020 ((https://www.sciencedirect.com/science/article/pii/S0300957220304901?via%3Dihub) - Long-term and secondary outcomes paper: Target early 2020 - Report to funding body (HTA): Draft report submitted May 2020 - Cost effectiveness publication: Target early 2020 Draft report submitted for publication The draft report to the funding body will be has been sent to the NIHR, and will provide provides a summary of the work undertaken during the life of the project. This report was initially due in October 2018. However, it look took longer than anticipated to receive the data from NHS Digital required to complete this report. As such, the HTA granted a 12 month extension various extensions to the project end date, and the report to the funding body is now due was submitted in October 2019. Data already received from NHS Digital is required to be kept for longer to allow the study team to complete the report to the funding body. May 2020. [1 paragraph unchanged] A publication looking at the long-term and secondary outcomes for the study is in draft. This output was on hold pending data from NHS Digital, and the required analyses can now be started as data has very recently been received. The target journal is Resuscitation. The health economics/cost effectiveness publication is also in draft, and was also on hold pending data from NHS Digital. The target journal is Resuscitation. Data already received from NHS Digital is required to be kept for longer to allow the study team to complete these, and other, publications. [2 paragraphs unchanged] Presentations have been given at a range of national and international conferences [28 words unchanged] Research Forum, Cardiac Arrest Symposium and many more. Further presentations are planned, including at particularly relating to the Society of Clinical Trials meeting. health economics/cost effectiveness findings. The data will not be linked to any other data not already noted in this agreement. The primary results of the AIRWAYS-2 trial have been published in JAMA (Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA. Effect of a strategy of a supraglottic airway device vs tracheal intubation during out-of hospital cardiac arrest on functional outcome: the AIRWAYS-2 randomized clinical trial. Journal of the American Medical Association. 2018;320(8):779-791. doi:10.1001/jama.2018.11597), and this publication was also the subject of a National Institute for Health Research (NIHR) Dissemination Centre “Signal” (https://discover.dc.nihr.ac.uk/content/signal-000686/new-airway-device-as-good-as-tracheal-tube-for-resuscitation-out-of-hospital). These results have been widely presented nationally and internationally, including to the National Association of Ambulance Service Medical Directors and Lead Paramedics Group, and to the Canadian Organisation of Paramedic Regulators, supported by a wide range of podcasts, social media and blog posts. The main trial results have been published, as have two challenges papers relating to trial set-up both in the pre-hospital (i.e. paramedic) and in-hospital settings

Expected measurable benefits

Because resuscitation for OHCA is strongly protocol driven, the study team anticipates anticipated that the findings from AIRWAYS-2 will would be readily adopted into practice (by the end of 2019) through changes to accepted guidelines. Changes to internationally accepted resuscitation guidelines are [19 words unchanged] liaison between principal resuscitation organisations worldwide. At present, ILCOR comprises representatives of: [7 paragraphs unchanged] One of the AIRWAYS-2 co-applicant team (Professor Nolan) is a past Chairman of the Resuscitation Council UK. They are Editor-in-Chief [29 words unchanged] the findings from AIRWAYS-2 are incorporated into ILCOR's rapid review process (see https://volunteer.heart.org/apps/pico/Pages/default.aspx ) https://volunteer.heart.org/apps/pico/Pages/default.aspx) and an update to internationally accepted and adopted resuscitation guidance, with direct reference to AIRWAYS-2, is expected was published in November 2019 (see https://www.resuscitationjournal.com/article/S0300-9572(19)30665-3/fulltext). Ambulance Trusts throughout the UK, and internationally, are also starting to be published change their local protocols relating to advanced airway management in out of hospital cardiac arrest, with a move toward the use of the supraglottic airway device and, in some cases, removal of tracheal intubation as a paramedic skill. These changes are partly driven by autumn 2019. the evidence from the AIRWAYS-2 trial, as well as the aerosol generating nature of intubation during the COVID-19 pandemic. The primary results of the AIRWAYS-2 trial have been published in JAMA (Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA. Effect of a strategy of a supraglottic airway device vs tracheal intubation during out-of hospital cardiac arrest on functional outcome: the AIRWAYS-2 randomized clinical trial. Journal of the American Medical Association. 2018;320(8):779-791. doi:10.1001/jama.2018.11597), and this publication was also the subject of a National Institute for Health Research (NIHR) Dissemination Centre “Signal” (https://discover.dc.nihr.ac.uk/content/signal-000686/new-airway-device-as-good-as-tracheal-tube-for-resuscitation-out-of-hospital). These results have been widely presented nationally and internationally, including to the National Association of Ambulance Service Medical Directors and Lead Paramedics Group, and to the Canadian Organisation of Paramedic Regulators, supported by a wide range of podcasts, social media and blog posts. The report to the funding body will be sent to the NIHR in October 2019 and will provide a summary of the work undertaken during the life of the project. A summary was provided to stakeholders both externally (e.g. general public/patients, media, commissioners) and internally (e.g. participating Trust stuff, operational staff). The longer-term outcomes from AIRWAYS-2 and a comprehensive economic analysis are currently in draft, and are eagerly awaited in order to further guide implementation and practice. The target journal for both publications is the journal Resuscitation, with the intention to publish early in 2020. [7 paragraphs unchanged] This study has the potential to improve the quality of CPR, survival [27 words unchanged] resources. We anticipate potential gains for individual patients, the wider NHS and society as a whole. society. This study is also likely to lead to rapid and important changes in the treatment protocols recommended by the International Liaison Committee on Resuscitation(ILCOR), which is an organisation that provides an opportunity for the major groups engaged in resuscitation worldwide to work together on CPR and emergency cardiovascular care protocols. This study is not in support of a PhD/postgraduate research study.

Benefits reported

The main trial results have been published, with a number of additional papers to follow. This has been supported by a wide range of dissemination activity, and the outputs from the trial are now being translated into clinical practice. The trial team are closely monitoring clinical guidance and practice nationally and internationally in order to collect evidence of impact, as outlined in the benefits statement. The study anticipate that clear indications of this will be seen in due course. [1 paragraph unchanged] Some UK Ambulance Trusts, including SWAST, have changed their resuscitation practices in line with the ILCOR guidelines, which have been influenced by the results of this trial (https://www.ilcor.org/publications). The long-term and secondary outcomes paper found that there were no significant differences in outcomes between the TI and i-gel groups at three and six months after non-traumatic OHCA. This finding will likely have an impact on healthcare policy.