Sentinel Stroke National Audit Programme

Healthcare Quality Improvement Partnership (HQIP) and NHS England (NHSE) require access to NHS England data for the purpose of the following audit programme: Sentinel Stroke National Audit Programme (SSNAP).

SSNAP is based in the School of Population Health and Environmental Studies at King’s College London (KCL). SSNAP measures the quality and organisation of stroke care in the NHS and is the single source of stroke data in England, Wales, and Northern Ireland.

SSNAP measures both the processes of care (clinical audit) provided to stroke patients, as well as the structure of stroke services (organisational audit) against evidence-based standards, including the 2016 National Clinical Guideline for Stroke.

The clinical audit collects a minimum data-set for stroke patients in England, Wales, and Northern Ireland in every acute hospital, and follows the pathway through recovery, rehabilitation, and patient outcomes at a 6-month assessment for each patient. It is the only national stroke register in the world to collect longitudinal data on the processes and outcomes of stroke care up to 6 months post stroke. Every year, data from approximately 85,000 patients are submitted to the audit web-tool for analysis, representing over 90% of all stroke hospital admissions in the NHS.

The overall aim of SSNAP is to provide timely information to clinicians, commissioners, patients, and the public on how well stroke care is being delivered so it can be used as a tool to improve the quality of care that is provided to patients.

The following is a summary of the aims of the audit programme provided by or on behalf of HQIP and NHSE:

• to benchmark services regionally and nationally.

• to monitor progress against a background of organisational change to stroke services and more generally in the NHS.

• to support clinicians in identifying where improvements are needed, planning for and lobbying for change and celebrating success.

• to empower patients to ask searching questions.

The following NHS England data will be accessed:

• Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary for the following reasons:

­ to link with SSNAP data to report case ascertainment levels vital in deciding how results, including 30-day mortality, are presented and used. Case ascertainment is a measure of the number of cases reported in the audit compared to the number of cases identified in HES.

­ to link with SSNAP data to report on important outcome measures such as comorbidities and days at home, in order to support the NHSE Long Term Plan work.

­ to identify any re-admissions and further strokes to compare quality of care with outcomes for patients.

• Civil Registrations of Death (CRD) – necessary for the following reasons:

­ to link with SSNAP data to report case mix adjusted 30-day mortality rates and longer-term survival rates for acute hospitals in England and Wales.

­ to link with SSNAP data to enable clinical teams to review the quality of care delivered against patient outcomes and make improvements to how the care of stroke patients is managed in the future.

­ to show survival at other intervals such as at 6 months and 1 year.

The level of the data will be:

• Identifiable for CRD – necessary to evaluate the success of the data linkage or to ensure data records are up to date and accurate.

• Pseudonymised for HES APC

The data will be minimised as follows:

• Limited to a cohort of 300,000 stroke patients identified by KCL. The cohort only comprises stroke patients who have been admitted to hospital.

• Limited to data from 2020/2021 onwards. For each individual patient, data will only be provided from the onset time of stroke.

The common law duty of confidentiality is addressed by:

• Section 251 from the onset time of stroke until 6 months after the stroke.

• Consent from 6 months after the stroke onwards.

HQIP and NHSE are the joint controllers as the organisations responsible for ensuring that the data will only be processed for the purposes described above. NHS England are the controllers for English data and Digital Health Care Wales (DHCW) are controller for the Welsh data alongside HQIP.

Civil Registrations of Death (CRD) dataset contains data from both England and Wales. As such DHCW have not been added as a joint controller under this agreement due to the dissemination of HES APC data. for England. An aligned data sharing agreement has been setup to cover the dissemination of Welsh mortality data under DARS -NIC-721538-N6B1V-v0.

The lawful basis for processing personal data for both HQIP and NHSE under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data for HQIP under the UK GDPR is:

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

This processing is in the public interest because it aims to drive improvements in the quality and safety of care, and to improve outcomes for patients.

The lawful basis for processing special category data for NHSE under the UK GDPR is:

Article 9(2)(h) - processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Domestic Law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3.

The funding is provided by HQIP. The funding is specifically for the audit programme described. Funding is in place until 31/03/2026.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

King's College London (KCL) and Net Solving Limited are processors acting under the instructions of HQIP and NHSE. KCL role is limited to managing the SSNAP audit.

SSNAP regularly (usually annually) meet patient groups to gain feedback about important issues for patients. There are patient representatives seated on SSNAP’s steering group – the ICSWP (The Intercollegiate Stroke Working Party). SSNAP work in collaboration with stroke survivors and carers, particularly with Speakeasy which is a charity based in Bury which supports people with aphasia, and the Stroke Research Patient and Family Group which is based at King’s College London. SSNAP has and will continue to meet regularly with these groups.

The expected outputs of the processing will be:

• A database to be utilised as a resource for health research via the SSNAP web tool.

• The following outputs are expected to be produced regarding mortality within 30 days of hospital admission for stroke:

o An annual report at Inetgrated Care Board (ICB) / Local Health Board (LHB) level (see www.strokeaudit.org/annualreport).

o An ICB/LHB dashboard.

o An ICB/LHB public table of mortality results per ICB/LHB which are available at https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx.

o A team level public table of mortality results per team which is available at https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx. (Team usually equates to a hospital).

• Quarterly and annual reports of audit case ascertainment information. Teams are assigned an A-E score based on number of patients submitted to SSNAP compared to expected figures as indicated by HES data.

• For statistical purposes such as monitoring trends, approved clinical users and registered individuals at Trusts can access date of death for patients they submit to the audit derived from NHSE mortality data. This information is accessible to clinical users at participating teams via the SSNAP webtool.

The outputs 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:

• All published reports are hosted on the SSNAP website (www.strokeaudit.org).

• National and international clinician conferences (e.g., European Stroke Organisation Conference).

• National patient-focused conferences (e.g., Annual Stroke Club Conference). Flyers, leaflets and reports can be found at https://www.strokeaudit.org/PatientInfo.aspx.

• Press releases, newsletters, e-bulletins including those run by King’s College London and the Stroke Association, and twitter (@SSNAPAudit).

• Flyers have been created to provide simple, succinct information on how to interpret mortality results. Ebooks, online interactive reports, audiobooks, and online videos have been used to present results in accessible, innovative formats (see www.strokeaudit.org).

Case ascertainment reports are produced quarterly. Mortality reporting is undertaken at an annual level.

Case ascertainment information from HES has been used to target trusts who were not achieving good levels of data entry to the audit in previous years, which has resulted in those trusts entering more records onto SSNAP, therefore improving the overall case ascertainment of the audit and reducing potential biases. This results in higher quality data being used for decision making at trust level and nationally.

The benefit of the receipt of HES data is therefore to enable a useful audit dataset, and the use of previous years’ HES has ensured the audit’s reputation as a high quality data source. It has enabled audit data to be used to highlight areas of unwarranted variation across the country, to identify key areas for improvement, and for use in a number of parliamentary questions

Mortality information has been fed back to trusts in case-mix adjusted models, and outlier trusts have been identified. These trusts were contacted and encouraged to undertake case note reviews of their fatalities to identify areas for improvement. Outlying trusts were also offered a full peer review visit by the Stroke Programme, and a number of outlying trusts have taken up this offer to help identify where improvements in their service need to be made. Subsequent quality improvement programmes are then implemented by those outlier services. The ability to adjust for variables such as stroke severity using the SSNAP Civil Registration/Mortality methodology is important, as stroke severity is a very strong predictor of mortality.

Statistical analyses of the HES and Civil Registration/Mortality data have looked at variation in stroke care and outcomes based on the presence of other diagnoses, socioeconomic status, and organisational characteristics of the hospitals treating the patients. Some of these analyses have already been published. In 2018 the paper ‘Socioeconomic disparities in first stroke incidence, quality of care, and survival’ was published in The Lancet. It is available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887080/. Such analyses have the potential to highlight key areas for improvement and to drive change..

The following provides background information on the purpose of the original study:

The Sentinel Stroke National Audit Programme (SSNAP) is a major National Healthcare Quality Improvement Partnership (HQIP) audit programme based in the School of Population Health and Environmental Studies at King’s College London. SSNAP measures the quality and organisation of stroke care in the NHS and is the single source of stroke data in England, Wales, and Northern Ireland.

SSNAP measures both the processes of care (clinical audit) provided to stroke patients, as well as the structure of stroke services (organisational audit) against evidence-based standards, including the 2016 National Clinical Guideline for Stroke. The overall aim of SSNAP is to provide timely information to clinicians, commissioners, patients, and the public on how well stroke care is being delivered so it can be used as a tool to improve the quality of care that is provided to patients. SSNAP has been voted the most effective national clinical audit in the UK for seven consecutive years by healthcare professionals involved in audit.

The clinical audit collects a minimum data-set for stroke patients in England, Wales and Northern Ireland in every acute hospital, and follows the pathway through recovery, rehabilitation, and patient outcomes at a 6 month assessment for each patient. It is the only national stroke register in the world to collect longitudinal data on the processes and outcomes of stroke care up to six months post stroke. Every year data from approximately 85,000 patients are submitted to the audit web-tool for analysis, representing over 90% of all stroke hospital admissions in the NHS.

The aims of the SSNAP clinical audit are:

• to benchmark services regionally and nationally

• to monitor progress against a background of organisational change to stroke services and more generally in the NHS.

• to support clinicians in identifying where improvements are needed, planning for and lobbying for change and celebrating success.

• to empower patients to ask searching questions

NHS England (NHSE) and HQIP are joint data controllers for the purposes of the SSNAP Clinical audit as they determine the aims and objectives of the project. KCL have been contracted to carry out this project. King's College London (KCL) and Net Solving are the contracted data processors for this agreement.

This agreement has a mixed approach to the common law duty of confidentiality:

1) s251 for the first six months following the stroke

2) Consent from six months onwards.

This is because many patients cannot communicate after a stroke, full representation and coverage is needed, and the cohort size means it is unrealistic to gain consent for every patient.

SSNAP has received section 251 support from the Confidentially Advisory Group (CAG) (Reference: ECC 6-02(FT3)2012) of the Health Research Authority (HRA) for patients to have their data included and processed on SSNAP following their stroke, setting aside the common law duty of confidentiality. This exemption covers from the onset time of stroke until six months after stroke - therefore, the NHS Digital data requested under s251 is required from initial admission to hospital until six months after the stroke. The NHS Digital data relates only to stroke patients who have been admitted to hospital. As a national quality improvement programme, aimed at improving the care processes and outcomes for patients after stroke, it has been agreed that collecting and reporting on these data at patient level is in the public interest. There are three principal reasons for why this exemption has been granted:

1) Many patients cannot communicate after stroke either because of reduced level of consciousness, specific language or cognitive difficulties or because they die in the hours or days following a stroke meaning informed consent is not possible.

2) It is necessary for full representation and complete coverage which is required in order to produce valid and comprehensive conclusions on care quality and outcomes. If informed consent were required as a prerequisite to be able to collect and analyse this data, the experience of many patients, particularly the most vulnerable, would be excluded;

3) The cohort size makes it unrealistic to gain consent for every patient. There are more than 85,000 cases per year for analysis, over 40% of whom will have communication difficulties.

Participating hospitals informing patients about SSNAP:

It is appreciated that even with section 251 support, compliance with the data protection act must be maintained and individuals have a right to know who holds information on them and why. To ensure this requirement is met appropriate fair processing information has been made available to participating hospitals. These hospitals are required to ensure information regarding their participation in SSNAP is available on stroke wards. The hospitals should also provide additional information on SSNAP to patients if requested as part of the terms and conditions for participation. If a patient objects to being included on SSNAP it is the responsibility of the service (the hospital) to remove that patient from the database. The SSNAP team cannot do this as the programme cannot view patient identifiable as part of section 251 exemption.

Consent materials and information sheets produced by SSNAP for patients:

Patient information sheets are publicly available on the SSNAP website including privacy notices and fair processing statements (https://www.strokeaudit.org/SupportFiles/Documents/Governance/Fair-Processing-Statement-for-SSNAP-users-v2-0.aspx

https://www.strokeaudit.org/SupportFiles/Documents/Patient-Docs/Fair-processing-statement-for-patients-v6-0.aspx) detailing how patient information is captured, stored and used by SSNAP. At the time of a patient’s six month assessment explicit consent is actively sought by the service provider and SSNAP have created consent forms for use by service providers at the time of a patient’s 6 month assessment. These materials are produced in two forms: a full text version containing detailed guidance; and an aphasia friendly version which uses simple language and pictorial guides for those people with communication difficulties after stroke. This is in line with the guidance laid out on https://understandingpatientdata.org.uk in particular that ‘language understandable to the data subjects’. Guidance on how individuals can withdraw consent at any time is also provided within these information sheets. These materials are targeted at stroke survivors and carers, clinical teams responsible for treating patients and managing SSNAP data, research teams interested in using SSNAP data and anyone else with an interest in how SSNAP data is collected, processed and reported.

Objective of this Agreement

The aims of this application are twofold: to link both civil registration/mortality data with SSNAP data in to order report case mix adjusted 30 day mortality rates and longer term survival rates for acute hospitals in England and Wales and; to link with hospital episode statistics (HES) data in order to report case ascertainment levels vital in deciding how results, including 30 day mortality, are presented and used. HES linked data will also be used to report on important outcome measures such as comorbidities and days at home, in order to support the NHSE Long Term Plan work.

Objective for processing Civil Registration/Mortality data

Only by linking SSNAP data to Civil Registration/Mortality data is it possible to report outcomes including 30 day mortality after stroke. These outcomes are provided back to the clinical teams who have treated the patients. This linkage enables clinical teams to review the quality of care delivered against patient outcomes and make improvements to how the care of stroke patients is managed in the future. Having access to these data is therefore vitally important for quality improvement in stroke care which is in the public interest.

KCL have historically been responsible for producing the CCG Outcomes Indicator Set (CCGOIS) measure of mortality at 30 days for stroke patients. SSNAP will be producing Integrated care board (ICB) level mortality reports with the move from CCG to ICBs, and should the CCGOIS be replaced with an ICB version of this report, it is expected that SSNAP will be responsible for producing this measure for an ICB version. Only by receiving the required data can these results be reported. These results are provided to NHS Digital to publish as part of the wider CCGOIS. The results are also provided at team level to provide necessary context on the performance of clinical teams treating stroke patients. As well as reporting on 30 day mortality, there is a need to show survival at other intervals such as at 6 months and 1 year. The outputs of the analysis by KCL will include mortality statistics at different time points and at different levels of granularity and dates of death will be used in statistical modelling.

The Civil Registration/Mortality data requested are for all patients in England and Wales since it is important to have complete, national level data on mortality to avoid selection bias and enable any socioeconomic or geographic factors impacting care received to be investigated. Only aggregate level mortality outputs are shared in the public domain with small number suppression in line with the HES analysis guide.

Objective for processing HES data

The HES data-set is used to determine the case ascertainment (case ascertainment is a measure of the number of cases reported in the audit, compared to the number of cases identified in HES) of participants of SSNAP, that is, the proportion of coded stroke patients which are recorded in the audit; and identify any re-admissions and further strokes, in order to compare quality of care with outcomes for patients. As the outputs of analysis of SSNAP are reported and publicly available, the proportion of patients entered into the audit for each hospital team, compared with the numbers in HES, is vital in determining how results are used (for instance, if there is low case ascertainment, the mortality outcomes would not be reported so that there is no potential misrepresentation).

Similarly without HES linkage it would not be possible to evaluate how complete or robust data submitted to SSNAP is, risking misrepresentation of results and how well or poorly hospitals are performing.

No NHSD data is made available to users or researchers to request. The NHSD data received by SSNAP is not used beyond the processing activities that have been listed on this Agreement.

Service level (hospital) and ICB/LHB (Local Health Board) level outputs

Civil Registration/ Mortality Data and HES: Indicators will be produced showing the performance of organisations and at national level for the purpose of monitoring and quality improvement, in particular:

• Mortality within 30 days of hospital admission for stroke CCG Outcomes Indictor Set (CCGOIS) at least annually (first publication on 17 December 2014, last publication in 2019, next publication anticipated TBC). The outputs generated at ICB/LHB level containing Civil Registration/Mortality data are: a ICB/LHB dashboard for each CCGOIS measure including 30 day mortality; a ICB/LHB public table of mortality including a funnel plot of results per ICB/LHB which are available here https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Mortality within 30 days of hospital admission for stroke Team-level mortality results (published in line with CCGOIS and used for contextualising the results). (Team usually equates to a hospital). The outputs generated at team (hospital level) containing Civil Registration/Mortality data are: a team level public table of mortality including a funnel plot of results per team which is available here: https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Audit case ascertainment information included in quarterly and annual reports. Teams are assigned an A-E score based on number of patients submitted to SSNAP compared to expected figures as indicated by HES data.

• For statistical purposes such as monitoring trends approved clinical users (see explanation in SSNAP webtool section of processing activities) registered individuals at Trusts can access date of death for patients they submit to the audit derived from Civil Registration/Mortality data. This information is accessible to clinical users at participating teams via section 9 of the SSNAP webtool.

• No published reporting outputs contain patient identifiable information, only aggregate level information with small number suppression.

Timeline for report production:

Case ascertainment levels are a key component of many SSNAP reports. These reports are produced quarterly and case ascertainment is provided as both a total score and as a A-E banding depending on levels of data completeness. SSNAP’s quarterly outputs are disseminated to teams within 3 weeks of each quarterly data locking deadline.

Mortality reporting is undertaken at an annual level only. The timeline for generating mortality reports depends on accessibility of required Civil Registration/Mortality data. However once this has been made available to SSNAP the resulting outputs are produced and shared with clinical teams within approximately one month.

Dissemination of reporting outputs:

Dissemination of SSNAP results containing Civil Registration/Mortality/HES data follows an agreed phased approach. This means that clinical teams are initially provided with their own results for review and further analysis before reports are shared within the wider NHS domain and then finally released to the public. All published reports are hosted on the SSNAP website (www.strokeaudit.org) at aggregate level only and with suppression of small numbers in line with the HES analysis guide. It has been agreed that those teams responsible for submitting continuous data should have access to their own results before they are shared more widely. At the time of writing there are more than 4,000 registered users on the SSNAP webtool who are contacted when new results are made available. Website analytics reports (aggregated with small numbers suppressed) indicate that there are many thousands of website visitors accessing the results portal of the SSNAP website each month from the UK and across the continent.

Peer Reviewed Journals

Outputs produced using Civil Registration/Mortality/HES data are also disseminated in the form of peer reviewed research papers. Recent relevant publications include “Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry” “Associations between Stroke Mortality and Weekend Working by Stroke Specialist Physicians and Registered Nurses”. Full text versions are available here: www.strokeaudit.org/research. Again all journals only contain aggregated outputs with small number suppression in line with the HES analysis guide. No future journal submissions are planned at the moment.

Presenting findings at clinician conferences

Published findings are often shared at national and international conferences. For e.g. at the recent European Stroke Organisation Conference SSNAP won the Paola De Rango Award for research into disparity of stroke care between men and women https://eso-stroke.org/eso/paola-de-rango-award-recognises-improving-stroke-care-access-for-women /. SSNAP recently participated in the European Stroke Organisation Conference 2022, and plans to share published findings at the World Stroke Conference in October 2022.

Traditional and new media dissemination

Results and reports are shared with stakeholders via press releases, newsletters, e-bulletins including those run by King’s College London and the Stroke Association, and twitter (@SSNAPAudit). Flyers have been created to provide simple, succinct information on how to interpret mortality results. Ebooks, audiobooks and online videos have been used to present results in accessible, innovative formats. See www.strokeaudit.org to access this information.

Patient Involvement

Stroke patient involvement remains at the heart of SSNAP’s work. The programme regularly meet patient groups to showcase reports and gain feedback about important issues for patients (at least annually), while there are patient representatives seated on the ICSWP (The Intercollegiate Stroke Working Party) - SSNAP’s steering group. SSNAP also attends patient focused conferences across the country every year and more information about patient involvement, and flyers, leaflets and reports can be found at: https://www.strokeaudit.org/PatientInfo.aspx

Producing patient focused reporting outputs

SSNAP have drawn on extensive successful PPI (patient and public involvement) experience to date to ensure patient input is integral to reporting. For example, SSNAP’s existing Easy Access Versions (EAVs) of audit results were developed in response to feedback from and in collaboration with stroke survivors and carers in particular with Speakeasy – a charity based in Bury which supports people with aphasia - and the Stroke Research Patient and Family Group, based at King’s College London. SSNAP has and will continue to meet regularly with these groups to review the value and utility of EAVs and seek advice on the development of any new outputs.

SSNAP has also sought patient and public involvement in the development of an Annual Report. The development of this type of report has evolved over time by: being co-designed with the stroke survivor members of the ICSWP to ensure it covers issues of importance to stroke patients and their carers and families; featuring stories from stroke survivor and their families; including artwork created by stroke survivors. The latest annual report has focused primarily on stroke care quality improvement and includes case studies sourced directly from stroke survivors, emphasising the importance of QI (quality improvement) from a patient perspective. All four annual reports published to date are available on the SSNAP website www.strokeaudit.org/annualreport.

Acting on feedback received at patient groups and conferences; recent SSNAP Annual Reports have also used new media forms to maximise engagement with patients and carers. This has included: Ebooks, online interactive reports, and audiobook versions. The use of infographics and visualisations in the design maximises the impact. An indicator of public reaction and impact can be seen by the fact that the Annual Reports have been downloaded more than 100,000 times. It is invaluable as an exemplar of the potential benefits of this national audit.

Patient engagement at events and conferences

SSNAP have attended and presented at numerous patient focused conferences in recent years including the annual stroke club conference where the team have shared recent results, sought feedback on outputs and new forms of media communication such e-books and audiobooks and engaged with patient groups not previously aware of SSNAP. The team also attend the UK Stroke Assembly (North and South) every Summer to showcase SSNAP patient related materials and receive direct feedback from stroke survivors and carers.

Case ascertainment information from HES has been used to target trusts who were not achieving good levels of data entry to the audit in previous years, which has resulted in those trusts entering more records onto SSNAP, therefore improving the overall case ascertainment of the audit and reducing potential biases. This results in higher quality data being used for decision making at trust level and nationally.

Mortality information has been fed back to trusts in case-mix adjusted models, and outlier trusts have been identified. These trusts were contacted and encouraged to undertake case note reviews of their fatalities to identify areas for improvement. Outlying trusts were also offered a full peer review visit by the Stroke Programme, and a number of outlying trusts have taken up this offer to help identify where improvements in their service need to be made. The ability to adjust for variables such as stroke severity using the SSNAP Civil Registration/Mortality methodology is important, as stroke severity is a very strong predictor of mortality.

Statistical analyses of the HES and Civil Registration/Mortality data have looked at variation in stroke care and outcomes based on the presence of other diagnoses, socioeconomic status, and organisational characteristics of the hospitals treating the patients. Some of these analyses have already been published, and others are currently being written up for submission to peer review journals. In 2018 the paper ‘Socioeconomic disparities in first stroke incidence, quality of care, and survival’ was published in The Lancet. It is available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887080/. Such analyses have the potential to highlight key areas for improvement and to drive change.

This Data Sharing Agreement permits the retention and processing of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Kings College London to complete the necessary actions to enable a subsequent application to extend and renew the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

The Sentinel Stroke National Audit Programme (SSNAP) is a major National Healthcare Quality Improvement Partnership (HQIP) audit programme based in the School of Population Health and Environmental Studies at King’s College London. SSNAP measures the quality and organisation of stroke care in the NHS and is the single source of stroke data in England, Wales, and Northern Ireland.

SSNAP measures both the processes of care (clinical audit) provided to stroke patients, as well as the structure of stroke services (organisational audit) against evidence-based standards, including the 2016 National Clinical Guideline for Stroke. The overall aim of SSNAP is to provide timely information to clinicians, commissioners, patients, and the public on how well stroke care is being delivered so it can be used as a tool to improve the quality of care that is provided to patients. SSNAP has been voted the most effective national clinical audit in the UK for seven consecutive years by healthcare professionals involved in audit.

The clinical audit collects a minimum data-set for stroke patients in England, Wales and Northern Ireland in every acute hospital, and follows the pathway through recovery, rehabilitation, and patient outcomes at a 6 month assessment for each patient. It is the only national stroke register in the world to collect longitudinal data on the processes and outcomes of stroke care up to six months post stroke. Every year data from approximately 85,000 patients are submitted to the audit web-tool for analysis, representing over 90% of all stroke hospital admissions in the NHS.

The aims of the SSNAP clinical audit are:

• to benchmark services regionally and nationally

• to monitor progress against a background of organisational change to stroke services and more generally in the NHS.

• to support clinicians in identifying where improvements are needed, planning for and lobbying for change and celebrating success.

• to empower patients to ask searching questions

King's College London (KCL) and Net Solving are the contracted data processors for this agreement, with KCL having replaced the Royal College of Physicans as a data processor. The decision to be based at King’s College London (KCL) offers academic benefits and opportunities for development of the audit design, measures and outputs as well as retention of high-quality staff. It is seen as a positive step to enhance the high-quality data already submitted and implementing the programming and statistical package for analyses. The aim is to increase access to quality real-time data whilst maintaining benchmarked reports.

This agreement has a mixed approach to the common law duty of confidentiality:

1) s251 for the first six months following the stroke

2) Consent from six months onwards.

This is because many patients cannot communicate after a stroke, full representation and coverage is needed, and the cohort size means it is unrealistic to gain consent for every patient.

SSNAP has received section 251 support from the Confidentially Advisory Group (CAG) (Reference: ECC 6-02(FT3)2012) of the Health Research Authority (HRA) for patients to have their data included and processed on SSNAP following their stroke, setting aside the common law duty of confidentiality. This exemption covers from the onset time of stroke until six months after stroke. As a national quality improvement programme, aimed at improving the care processes and outcomes for patients after stroke, it has been agreed that collecting and reporting on these data at patient level is in the public interest. There are three principle reasons for why this exemption has been granted:

1) Many patients cannot communicate after stroke either because of reduced level of consciousness, specific language or cognitive difficulties or because they die in the hours or days following a stroke meaning informed consent is not possible. Similarly the concept of informed consent within the hours and days following a stroke is a difficult one for many patients;

2) It is necessary for full representation and complete coverage which is required in order to produce valid and comprehensive conclusions on care quality and outcomes. If informed consent were required as a prerequisite to be able to collect and analyse this data, the experience of many patients, particularly the most vulnerable, would be excluded;

3) The cohort size makes it unrealistic to gain consent for every patient. Each year more than 85,000 cases per year for analysis, over 40% of whom will have communication difficulties.

Participating hospitals informing patients about SSNAP:

It is appreciated that even with section 251 support compliance with the data protection act must be maintained and individuals have a right to know who holds information on them and why. To ensure this requirement is met appropriate fair processing information has been made available to participating hospitals. These hospitals are required to ensure information regarding their participation in SSNAP is available on stroke wards. The hospitals should also provide additional information on SSNAP to patients if requested as part of the terms and conditions for participation. If a patient objects to being included on SSNAP it is the responsibility of the service to remove that patient from the database. The SSNAP team cannot do this as the programme cannot view patient identifiable as part of section 251 exemption.

Consent materials and information sheets produced by SSNAP for patients:

Comprehensive patient information sheets are publicly available on the SSNAP website including privacy notices and fair processing statements detailing how patient information is captured, stored and used by SSNAP. At the time of a patient’s six month assessment explicit consent is actively sought by the service provider and SSNAP have created consent forms for use by service providers at the time of a patient’s 6 month assessment. These materials are produced in two forms: a full text version containing detailed guidance; and an aphasia friendly version which uses simple language and pictorial guides for those people with communication difficulties after stroke. This is in line with the guidance laid out on https://understandingpatientdata.org.uk in particular that ‘language understandable to the data subjects’. Guidance on how individuals can withdraw consent at any time is also provided within these information sheets. These materials are targeted at stroke survivors and carers, clinical teams responsible for treating patients and managing SSNAP data, research teams interested in using SSNAP data and anyone else with an interest in how SSNAP data is collected, processed and reported.

Objective of this application

The aims of this application are twofold: to link both civil registration/mortality data with SSNAP data in to order report case mix adjusted 30 day mortality rates and longer term survival rates for acute hospitals in England and Wales and; to link with hospital episode statistics (HES) data in order to report case ascertainment levels vital in deciding how results, including 30 day mortality, are presented and used.

Objective for processing Civil Registration/Mortality data

Only by linking SSNAP data to Civil Registration/Mortality data is it possible to report outcomes including 30 day mortality after stroke. These outcomes are provided back to the clinical teams who have treated the patients. This linkage enables clinical teams to review the quality of care delivered against patient outcomes and make improvements to how stroke patients are managed in the future. Having access to these data is therefore vitally important for quality improvement in stroke care which is in the public interest.

KCL are responsible for producing the CCG Outcomes Indicator Set (CCGOIS) measure of mortality at 30 days for stroke patients. Only by receiving the required data can these results be reported. These results are provided to NHS Digital to publish as part of the wider CCGOIS. The results are also provided at team level to provide necessary context on the performance of clinical teams treating stroke patients. As well as reporting on 30 day mortality, there is a need to show survival at other intervals such as at 6 months and 1 year. The outputs of the analysis by KCL will include mortality statistics at different time points and at different levels of granularity and dates of death will be used in statistical modelling.

The Civil Registration/Mortality data requested are for all patients in England and Wales since it is important to have complete, national level data on mortality to avoid selection bias and enable any socioeconomic or geographic factors impacting care received to be investigated. Only aggregate level mortality outputs are shared in the public domain with small number suppression in line with the HES analysis guide.

Objective for processing HES data

The HES data-set is used to determine the case ascertainment (case ascertainment is a measure of the number of cases reported in the audit, compared to the number of cases identified in HES) of participants of SSNAP, that is, the proportion of coded stroke patients which are recorded in the audit; and identify any re-admissions and further strokes, in order to compare quality of care with outcomes for patients. As the outputs of analysis of SSNAP are reported and publicly available, the proportion of patients entered into the audit for each hospital team, compared with the numbers in HES, is vital in determining how results are used (for instance, if there is low case ascertainment, the mortality outcomes would not be reported so that there is no potential misrepresentation).

Similarly without HES linkage it would not be possible to evaluate how complete or robust data submitted to SSNAP is, risking misrepresentation of results and how well or poorly hospitals are performing.

Service level (hospital) and CCG/LHB (Local Health Board) level outputs

Civil Registration/ Mortality Data and HES: Indicators will be produced showing the performance of organisations and at national level for the purpose of monitoring and quality improvement, in particular:

• Mortality within 30 days of hospital admission for stroke CCG Outcomes Indictor Set (CCGOIS) at least annually (first publication on 17 December 2014, next publication anticipated to be early 2019). The outputs generated at CCG/LHB level containing Civil Registration/Mortality data are: a CCG/LHB dashboard for each CCGOIS measure including 30 day mortality; a CCG/LHB public table of mortality including a funnel plot of results per CCG/LHB which are available here https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Mortality within 30 days of hospital admission for stroke Team-level mortality results (published in line with CCGOIS and used for contextualising the results). (Team usually equates to a hospital). The outputs generated at team (hospital level) containing Civil Registration/Mortality data are: a team level public table of mortality including a funnel plot of results per team which is available here: https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Audit case ascertainment information included in quarterly and annual reports. Teams are assigned an A-E score based on number of patients submitted to SSNAP compared to expected figures as indicated by HES data.

• For statistical purposes such as monitoring trends approved clinical users (see explanation in SSNAP webtool section of processing activities)registered individuals at Trusts can access date of death for patients they submit to the audit derived from Civil Registration/Mortality data. This information is accessible to clinical users at participating teams via section 9 of the SSNAP webtool.

• No published reporting outputs contain patient identifiable information, only aggregate level information with small number suppression.

Timeline for report production:

Case ascertainment levels are a key component of many SSNAP reports. These reports are produced quarterly and case ascertainment is provided as both a total score and as a A-E banding depending on levels of data completeness. SSNAP’s quarterly outputs are disseminated to teams within 3 weeks of each quarterly data locking deadline.

Mortality reporting is undertaken at an annual level only. The timeline for generating mortality reports depends on accessibility of required Civil Registration/Mortality data. However once this has been made available to SSNAP the resulting outputs are produced and shared with clinical teams within approximately one month.

Dissemination of reporting outputs:

Dissemination of SSNAP results containing Civil Registration/Mortality/HES data follows an agreed phased approach. This means that clinical teams are initially provided with their own results for review and further analysis before reports are shared within the wider NHS domain and then finally released to the public. All published reports are hosted on the SSNAP website (www.strokeaudit.org) at aggregate level only and with suppression of small numbers in line with the HES analysis guide. It has been agreed that those teams responsible for submitting continuous data should have access to their own results before they are shared more widely. At the time of writing there are more than 4,000 registered users on the SSNAP webtool who are contacted when new results are made available. Website analytics reports (aggregated with small numbers suppressed) indicate that there are many thousands of website visitors accessing the results portal of the SSNAP website each month from the UK and across the continent.

Peer Reviewed Journals

Outputs produced using Civil Registration/Mortality/HES data are also disseminated in the form of peer reviewed research papers. Recent relevant publications include “Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry” “Associations between Stroke Mortality and Weekend Working by Stroke Specialist Physicians and Registered Nurses”. Full text versions are available here: www.strokeaudit.org/research. Again all journals only contain aggregated outputs with small number suppression in line with the HES anlaysis guide.

Presenting findings at clinician conferences

Published findings are often shared at national and international conferences For e.g at the recent European Stroke Organisation Conference SSNAP won the Paola De Rango Award for research into disparity of stroke care between men and women https://eso-stroke.org/eso/paola-de-rango-award-recognises-improving-stroke-care-access-for-women/

Traditional and new media dissemination

Results and reports are shared with stakeholders via press releases, newsletters, e-bulletins including those run by King’s College London and the Stroke Association, and twitter. Flyers have been created to provide simple, succinct information on how to interpret mortality results. Ebooks, audiobooks and online videos have been used to present results in accessible, innovative formats.

Patient Involvement

Stroke patient involvement remains at the heart of SSNAP’s work. The programme regularly meet patient groups to showcase reports and gain feedback about important issues for patients, while there are patient representatives seated on the ICSWP (The Intercollegiate Stroke Working Party) - SSNAP’s steering group. SSNAP also attends patient focused conferences across the country every year and more information about patient involvement, and flyers, leaflets and reports can be found at: https://www.strokeaudit.org/PatientInfo.aspx

Producing patient focused reporting outputs

SSNAP have drawn on extensive successful PPI (patient and public involvement) experience to date to ensure patient input is integral to reporting. For example, SSNAP’s existing Easy Access Versions (EAVs) of audit results were developed in response to feedback from and in collaboration with stroke survivors and carers in particular with Speakeasy – a charity based in Bury which supports people with aphasia - and the Stroke Research Patient and Family Group, based at King’s College London. SSNAP has and will continue to meet regularly with these groups to review the value and utility of EAVs and seek advice on the development of any new outputs.

SSNAP has also sought patient and public involvement in the development of an Annual Report. The development of this type of report has evolved over time by: being co-designed with the stroke survivor members of the ICSWP to ensure it covers issues of importance to stroke patients and their carers and families; featuring stories from stroke survivor and their families; including artwork created by stroke survivors. The latest annual report has focused primarily on stroke care quality improvement and includes case studies sourced directly from stroke survivors, emphasising the importance of QI (quality improvement) from a patient perspective. All four annual reports published to date are available on the SSNAP website www.strokeaudit.org/annualreport.

Acting on feedback received at patient groups and conferences; recent SSNAP Annual Reports have also used new media forms to maximise engagement with patients and carers. This has included: Ebooks, online interactive reports, and audiobook versions. The use of infographics and visualisations in the design maximises the impact. An indicator of public reaction and impact can be seen by the fact that the Annual Reports have been downloaded more than 100,000 times. It is invaluable as an exemplar of the potential benefits of this national audit.

Patient engagement at events and conferences

SSNAP have attended and presented at numerous patient focused conferences in recent years including the annual stroke club conference where the team have shared recent results, sought feedback on outputs and new forms of media communication such e-books and audiobooks and engaged with patient groups not previously aware of SSNAP. The team also attend the UK Stroke Assembly (North and South) every Summer to showcase SSNAP patient related materials and receive direct feedback from stroke survivors and carers.

Case ascertainment information from HES has been used to target trusts who were not achieving good levels of data entry to the audit in previous years, which has resulted in those trusts entering more records onto SSNAP, therefore improving the overall case ascertainment of the audit and reducing potential biases. This results in higher quality data being used for decision making at trust level and nationally.

Mortality information has been fed back to trusts in case-mix adjusted models, and outlier trusts have been identified. These trusts were contacted and encouraged to undertake case note reviews of their fatalities to identify areas for improvement. Outlying trusts were also offered a full peer review visit by the Stroke Programme, and a number of outlying trusts have taken up this offer to help identify where improvements in their service need to be made. The ability to adjust for variables such as stroke severity using the SSNAP Civil Registration/Mortality methodology is important, as stroke severity is a very strong predictor of mortality.

Statistical analyses of the HES and Civil Registration/Mortality data have looked at variation in stroke care and outcomes based on the presence of other diagnoses, socioeconomic status, and organisational characteristics of the hospitals treating the patients. Some of these analyses have already been published, and others are currently being written up for submission to peer review journals. In 2018 the paper ‘Socioeconomic disparities in first stroke incidence, quality of care, and survival’ was published in The Lancet. It is available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887080/. Such analyses have the potential to highlight key areas for improvement and to drive change.

The Sentinel Stroke National Audit Programme (SSNAP) is a major National Healthcare Quality Improvement Partnership (HQIP) audit programme based in the School of Population Health and Environmental Studies at King’s College London. SSNAP measures the quality and organisation of stroke care in the NHS and is the single source of stroke data in England, Wales, and Northern Ireland.

SSNAP measures both the processes of care (clinical audit) provided to stroke patients, as well as the structure of stroke services (organisational audit) against evidence-based standards, including the 2016 National Clinical Guideline for Stroke. The overall aim of SSNAP is to provide timely information to clinicians, commissioners, patients, and the public on how well stroke care is being delivered so it can be used as a tool to improve the quality of care that is provided to patients. SSNAP has been voted the most effective national clinical audit in the UK for seven consecutive years by healthcare professionals involved in audit.

The clinical audit collects a minimum data-set for stroke patients in England, Wales and Northern Ireland in every acute hospital, and follows the pathway through recovery, rehabilitation, and patient outcomes at a 6 month assessment for each patient. It is the only national stroke register in the world to collect longitudinal data on the processes and outcomes of stroke care up to six months post stroke. Every year data from approximately 85,000 patients are submitted to the audit web-tool for analysis, representing over 90% of all stroke hospital admissions in the NHS.

The aims of the SSNAP clinical audit are:

• to benchmark services regionally and nationally

• to monitor progress against a background of organisational change to stroke services and more generally in the NHS.

• to support clinicians in identifying where improvements are needed, planning for and lobbying for change and celebrating success.

• to empower patients to ask searching questions

King's College London (KCL) and Net Solving are the contracted data processors for this agreement, with KCL having replaced the Royal College of Physicans as a data processor. The decision to be based at King’s College London (KCL) offers academic benefits and opportunities for development of the audit design, measures and outputs as well as retention of high-quality staff. It is seen as a positive step to enhance the high-quality data already submitted and implementing the programming and statistical package for analyses. The aim is to increase access to quality real-time data whilst maintaining benchmarked reports.

This agreement has a mixed approach to the common law duty of confidentiality:

1) s251 for the first six months following the stroke

2) Consent from six months onwards.

This is because many patients cannot communicate after a stroke, full representation and coverage is needed, and the cohort size means it is unrealistic to gain consent for every patient.

SSNAP has received section 251 support from the Confidentially Advisory Group (CAG) (Reference: ECC 6-02(FT3)2012) of the Health Research Authority (HRA) for patients to have their data included and processed on SSNAP following their stroke, setting aside the common law duty of confidentiality. This exemption covers from the onset time of stroke until six months after stroke. As a national quality improvement programme, aimed at improving the care processes and outcomes for patients after stroke, it has been agreed that collecting and reporting on these data at patient level is in the public interest. There are three principle reasons for why this exemption has been granted:

1) Many patients cannot communicate after stroke either because of reduced level of consciousness, specific language or cognitive difficulties or because they die in the hours or days following a stroke meaning informed consent is not possible. Similarly the concept of informed consent within the hours and days following a stroke is a difficult one for many patients;

2) It is necessary for full representation and complete coverage which is required in order to produce valid and comprehensive conclusions on care quality and outcomes. If informed consent were required as a prerequisite to be able to collect and analyse this data, the experience of many patients, particularly the most vulnerable, would be excluded;

3) The cohort size makes it unrealistic to gain consent for every patient. Each year more than 85,000 cases per year for analysis, over 40% of whom will have communication difficulties.

Participating hospitals informing patients about SSNAP:

It is appreciated that even with section 251 support compliance with the data protection act must be maintained and individuals have a right to know who holds information on them and why. To ensure this requirement is met appropriate fair processing information has been made available to participating hospitals. These hospitals are required to ensure information regarding their participation in SSNAP is available on stroke wards. The hospitals should also provide additional information on SSNAP to patients if requested as part of the terms and conditions for participation. If a patient objects to being included on SSNAP it is the responsibility of the service to remove that patient from the database. The SSNAP team cannot do this as the programme cannot view patient identifiable as part of section 251 exemption.

Consent materials and information sheets produced by SSNAP for patients:

Comprehensive patient information sheets are publicly available on the SSNAP website including privacy notices and fair processing statements detailing how patient information is captured, stored and used by SSNAP. At the time of a patient’s six month assessment explicit consent is actively sought by the service provider and SSNAP have created consent forms for use by service providers at the time of a patient’s 6 month assessment. These materials are produced in two forms: a full text version containing detailed guidance; and an aphasia friendly version which uses simple language and pictorial guides for those people with communication difficulties after stroke. This is in line with the guidance laid out on https://understandingpatientdata.org.uk in particular that ‘language understandable to the data subjects’. Guidance on how individuals can withdraw consent at any time is also provided within these information sheets. These materials are targeted at stroke survivors and carers, clinical teams responsible for treating patients and managing SSNAP data, research teams interested in using SSNAP data and anyone else with an interest in how SSNAP data is collected, processed and reported.

Objective of this application

The aims of this application are twofold: to link both civil registration/mortality data with SSNAP data in to order report case mix adjusted 30 day mortality rates and longer term survival rates for acute hospitals in England and Wales and; to link with hospital episode statistics (HES) data in order to report case ascertainment levels vital in deciding how results, including 30 day mortality, are presented and used.

Objective for processing Civil Registration/Mortality data

Only by linking SSNAP data to Civil Registration/Mortality data is it possible to report outcomes including 30 day mortality after stroke. These outcomes are provided back to the clinical teams who have treated the patients. This linkage enables clinical teams to review the quality of care delivered against patient outcomes and make improvements to how stroke patients are managed in the future. Having access to these data is therefore vitally important for quality improvement in stroke care which is in the public interest.

KCL are responsible for producing the CCG Outcomes Indicator Set (CCGOIS) measure of mortality at 30 days for stroke patients. Only by receiving the required data can these results be reported. These results are provided to NHS Digital to publish as part of the wider CCGOIS. The results are also provided at team level to provide necessary context on the performance of clinical teams treating stroke patients. As well as reporting on 30 day mortality, there is a need to show survival at other intervals such as at 6 months and 1 year. The outputs of the analysis by KCL will include mortality statistics at different time points and at different levels of granularity and dates of death will be used in statistical modelling.

The Civil Registration/Mortality data requested are for all patients in England and Wales since it is important to have complete, national level data on mortality to avoid selection bias and enable any socioeconomic or geographic factors impacting care received to be investigated. Only aggregate level mortality outputs are shared in the public domain with small number suppression in line with the HES analysis guide.

Objective for processing HES data

The HES data-set is used to determine the case ascertainment (case ascertainment is a measure of the number of cases reported in the audit, compared to the number of cases identified in HES) of participants of SSNAP, that is, the proportion of coded stroke patients which are recorded in the audit; and identify any re-admissions and further strokes, in order to compare quality of care with outcomes for patients. As the outputs of analysis of SSNAP are reported and publicly available, the proportion of patients entered into the audit for each hospital team, compared with the numbers in HES, is vital in determining how results are used (for instance, if there is low case ascertainment, the mortality outcomes would not be reported so that there is no potential misrepresentation).

Similarly without HES linkage it would not be possible to evaluate how complete or robust data submitted to SSNAP is, risking misrepresentation of results and how well or poorly hospitals are performing. HES linkage also facilitates additional important research to be undertaken on associated co-morbidities and outcomes after stroke, for e.g, increased association of dying from suicide after stroke or associations between dementia and stroke.

Service level (hospital) and CCG/LHB (Local Health Board) level outputs

Civil Registration/ Mortality Data and HES: Indicators will be produced showing the performance of organisations and at national level for the purpose of monitoring and quality improvement, in particular:

• Mortality within 30 days of hospital admission for stroke CCG Outcomes Indictor Set (CCGOIS) at least annually (first publication on 17 December 2014, next publication anticipated to be early 2019). The outputs generated at CCG/LHB level containing Civil Registration/Mortality data are: a CCG/LHB dashboard for each CCGOIS measure including 30 day mortality; a CCG/LHB public table of mortality including a funnel plot of results per CCG/LHB which are available here https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Mortality within 30 days of hospital admission for stroke Team-level mortality results (published in line with CCGOIS and used for contextualising the results). (Team usually equates to a hospital). The outputs generated at team (hospital level) containing Civil Registration/Mortality data are: a team level public table of mortality including a funnel plot of results per team which is available here: https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Audit case ascertainment information included in quarterly and annual reports. Teams are assigned an A-E score based on number of patients submitted to SSNAP compared to expected figures as indicated by HES data.

• For statistical purposes such as monitoring trends approved clinical users (see explanation in SSNAP webtool section of processing activities)registered individuals at Trusts can access date of death for patients they submit to the audit derived from Civil Registration/Mortality data. This information is accessible to clinical users at participating teams via section 9 of the SSNAP webtool.

• No published reporting outputs contain patient identifiable information, only aggregate level information with small number suppression.

Timeline for report production:

Case ascertainment levels are a key component of many SSNAP reports. These reports are produced quarterly and case ascertainment is provided as both a total score and as a A-E banding depending on levels of data completeness. SSNAP’s quarterly outputs are disseminated to teams within 3 weeks of each quarterly data locking deadline.

Mortality reporting is undertaken at an annual level only. The timeline for generating mortality reports depends on accessibility of required Civil Registration/Mortality data. However once this has been made available to SSNAP the resulting outputs are produced and shared with clinical teams within approximately one month.

Dissemination of reporting outputs:

Dissemination of SSNAP results containing Civil Registration/Mortality/HES data follows an agreed phased approach. This means that clinical teams are initially provided with their own results for review and further analysis before reports are shared within the wider NHS domain and then finally released to the public. All published reports are hosted on the SSNAP website (www.strokeaudit.org) at aggregate level only and with suppression of small numbers in line with the HES analysis guide. It has been agreed that those teams responsible for submitting continuous data should have access to their own results before they are shared more widely. At the time of writing there are more than 4,000 registered users on the SSNAP webtool who are contacted when new results are made available. Website analytics reports (aggregated with small numbers suppressed) indicate that there are many thousands of website visitors accessing the results portal of the SSNAP website each month from the UK and across the continent.

Peer Reviewed Journals

Outputs produced using Civil Registration/Mortality/HES data are also disseminated in the form of peer reviewed research papers. Recent relevant publications include “Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry” “Associations between Stroke Mortality and Weekend Working by Stroke Specialist Physicians and Registered Nurses”. Full text versions are available here: www.strokeaudit.org/research. Again all journals only contain aggregated outputs with small number suppression in line with the HES anlaysis guide.

Presenting findings at clinician conferences

Published findings are often shared at national and international conferences For e.g at the recent European Stroke Organisation Conference SSNAP won the Paola De Rango Award for research into disparity of stroke care between men and women https://eso-stroke.org/eso/paola-de-rango-award-recognises-improving-stroke-care-access-for-women/

Traditional and new media dissemination

Results and reports are shared with stakeholders via press releases, newsletters, e-bulletins including those run by King’s College London and the Stroke Association, and twitter. Flyers have been created to provide simple, succinct information on how to interpret mortality results. Ebooks, audiobooks and online videos have been used to present results in accessible, innovative formats.

Patient Involvement

Stroke patient involvement remains at the heart of SSNAP’s work. The programme regularly meet patient groups to showcase reports and gain feedback about important issues for patients, while there are patient representatives seated on the ICSWP (The Intercollegiate Stroke Working Party) - SSNAP’s steering group. SSNAP also attends patient focused conferences across the country every year and more information about patient involvement, and flyers, leaflets and reports can be found at: https://www.strokeaudit.org/PatientInfo.aspx

Producing patient focused reporting outputs

SSNAP have drawn on extensive successful PPI (patient and public involvement) experience to date to ensure patient input is integral to reporting. For example, SSNAP’s existing Easy Access Versions (EAVs) of audit results were developed in response to feedback from and in collaboration with stroke survivors and carers in particular with Speakeasy – a charity based in Bury which supports people with aphasia - and the Stroke Research Patient and Family Group, based at King’s College London. SSNAP has and will continue to meet regularly with these groups to review the value and utility of EAVs and seek advice on the development of any new outputs.

SSNAP has also sought patient and public involvement in the development of an Annual Report. The development of this type of report has evolved over time by: being co-designed with the stroke survivor members of the ICSWP to ensure it covers issues of importance to stroke patients and their carers and families; featuring stories from stroke survivor and their families; including artwork created by stroke survivors. The latest annual report has focused primarily on stroke care quality improvement and includes case studies sourced directly from stroke survivors, emphasising the importance of QI (quality improvement) from a patient perspective. All four annual reports published to date are available on the SSNAP website www.strokeaudit.org/annualreport.

Acting on feedback received at patient groups and conferences; recent SSNAP Annual Reports have also used new media forms to maximise engagement with patients and carers. This has included: Ebooks, online interactive reports, and audiobook versions. The use of infographics and visualisations in the design maximises the impact. An indicator of public reaction and impact can be seen by the fact that the Annual Reports have been downloaded more than 100,000 times. It is invaluable as an exemplar of the potential benefits of this national audit.

Patient engagement at events and conferences

SSNAP have attended and presented at numerous patient focused conferences in recent years including the annual stroke club conference where the team have shared recent results, sought feedback on outputs and new forms of media communication such e-books and audiobooks and engaged with patient groups not previously aware of SSNAP. The team also attend the UK Stroke Assembly (North and South) every Summer to showcase SSNAP patient related materials and receive direct feedback from stroke survivors and carers.

Case ascertainment information from HES has been used to target trusts who were not achieving good levels of data entry to the audit in previous years, which has resulted in those trusts entering more records onto SSNAP, therefore improving the overall case ascertainment of the audit and reducing potential biases. This results in higher quality data being used for decision making at trust level and nationally.

Mortality information has been fed back to trusts in case-mix adjusted models, and outlier trusts have been identified. These trusts were contacted and encouraged to undertake case note reviews of their fatalities to identify areas for improvement. Outlying trusts were also offered a full peer review visit by the Stroke Programme, and a number of outlying trusts have taken up this offer to help identify where improvements in their service need to be made. The ability to adjust for variables such as stroke severity using the SSNAP Civil Registration/Mortality methodology is important, as stroke severity is a very strong predictor of mortality.

Statistical analyses of the HES and Civil Registration/Mortality data have looked at variation in stroke care and outcomes based on the presence of other diagnoses, socioeconomic status, and organisational characteristics of the hospitals treating the patients. Some of these analyses have already been published, and others are currently being written up for submission to peer review journals. In 2018 the paper ‘Socioeconomic disparities in first stroke incidence, quality of care, and survival’ was published in The Lancet. It is available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887080/. Such analyses have the potential to highlight key areas for improvement and to drive change.

The Sentinel Stroke National Audit Programme (SSNAP) is a major National Healthcare Quality Improvement Partnership (HQIP) audit programme based in the School of Population Health and Environmental Studies at King’s College London. SSNAP measures the quality and organisation of stroke care in the NHS and is the single source of stroke data in England, Wales, and Northern Ireland.

SSNAP measures both the processes of care (clinical audit) provided to stroke patients, as well as the structure of stroke services (organisational audit) against evidence-based standards, including the 2016 National Clinical Guideline for Stroke. The overall aim of SSNAP is to provide timely information to clinicians, commissioners, patients, and the public on how well stroke care is being delivered so it can be used as a tool to improve the quality of care that is provided to patients. SSNAP has been voted the most effective national clinical audit in the UK for seven consecutive years by healthcare professionals involved in audit.

The clinical audit collects a minimum data-set for stroke patients in England, Wales and Northern Ireland in every acute hospital, and follows the pathway through recovery, rehabilitation, and patient outcomes at a 6 month assessment for each patient. It is the only national stroke register in the world to collect longitudinal data on the processes and outcomes of stroke care up to six months post stroke. Every year data from approximately 85,000 patients are submitted to the audit web-tool for analysis, representing over 90% of all stroke hospital admissions in the NHS.

The aims of the SSNAP clinical audit are:

• to benchmark services regionally and nationally

• to monitor progress against a background of organisational change to stroke services and more generally in the NHS.

• to support clinicians in identifying where improvements are needed, planning for and lobbying for change and celebrating success.

• to empower patients to ask searching questions

King's College London (KCL) and Net Solving are the contracted data processors for this agreement, with KCL having replaced the Royal College of Physicans as a data processor. The decision to be based at King’s College London (KCL) offers academic benefits and opportunities for development of the audit design, measures and outputs as well as retention of high-quality staff. It is seen as a positive step to enhance the high-quality data already submitted and implementing the programming and statistical package for analyses. The aim is to increase access to quality real-time data whilst maintaining benchmarked reports.

This agreement has a mixed approach to the common law duty of confidentiality:

1) s251 for the first six months following the stroke

2) Consent from six months onwards.

This is because many patients cannot communicate after a stroke, full representation and coverage is needed, and the cohort size means it is unrealistic to gain consent for every patient.

SSNAP has received section 251 support from the Confidentially Advisory Group (CAG) (Reference: ECC 6-02(FT3)2012) of the Health Research Authority (HRA) for patients to have their data included and processed on SSNAP following their stroke, setting aside the common law duty of confidentiality. This exemption covers from the onset time of stroke until six months after stroke. As a national quality improvement programme, aimed at improving the care processes and outcomes for patients after stroke, it has been agreed that collecting and reporting on these data at patient level is in the public interest. There are three principle reasons for why this exemption has been granted:

1) Many patients cannot communicate after stroke either because of reduced level of consciousness, specific language or cognitive difficulties or because they die in the hours or days following a stroke meaning informed consent is not possible. Similarly the concept of informed consent within the hours and days following a stroke is a difficult one for many patients;

2) It is necessary for full representation and complete coverage which is required in order to produce valid and comprehensive conclusions on care quality and outcomes. If informed consent were required as a prerequisite to be able to collect and analyse this data, the experience of many patients, particularly the most vulnerable, would be excluded;

3) The cohort size makes it unrealistic to gain consent for every patient. Each year more than 85,000 cases per year for analysis, over 40% of whom will have communication difficulties.

Participating hospitals informing patients about SSNAP:

It is appreciated that even with section 251 support compliance with the data protection act must be maintained and individuals have a right to know who holds information on them and why. To ensure this requirement is met appropriate fair processing information has been made available to participating hospitals. These hospitals are required to ensure information regarding their participation in SSNAP is available on stroke wards. The hospitals should also provide additional information on SSNAP to patients if requested as part of the terms and conditions for participation. If a patient objects to being included on SSNAP it is the responsibility of the service to remove that patient from the database. The SSNAP team cannot do this as the programme cannot view patient identifiable as part of section 251 exemption.

Consent materials and information sheets produced by SSNAP for patients:

Comprehensive patient information sheets are publicly available on the SSNAP website including privacy notices and fair processing statements detailing how patient information is captured, stored and used by SSNAP. At the time of a patient’s six month assessment explicit consent is actively sought by the service provider and SSNAP have created consent forms for use by service providers at the time of a patient’s 6 month assessment. These materials are produced in two forms: a full text version containing detailed guidance; and an aphasia friendly version which uses simple language and pictorial guides for those people with communication difficulties after stroke. This is in line with the guidance laid out on https://understandingpatientdata.org.uk in particular that ‘language understandable to the data subjects’. Guidance on how individuals can withdraw consent at any time is also provided within these information sheets. These materials are targeted at stroke survivors and carers, clinical teams responsible for treating patients and managing SSNAP data, research teams interested in using SSNAP data and anyone else with an interest in how SSNAP data is collected, processed and reported.

Objective of this application

The aims of this application are twofold: to link both civil registration/mortality data with SSNAP data in to order report case mix adjusted 30 day mortality rates and longer term survival rates for acute hospitals in England and Wales and; to link with hospital episode statistics (HES) data in order to report case ascertainment levels vital in deciding how results, including 30 day mortality, are presented and used.

Objective for processing Civil Registration/Mortality data

Only by linking SSNAP data to Civil Registration/Mortality data is it possible to report outcomes including 30 day mortality after stroke. These outcomes are provided back to the clinical teams who have treated the patients. This linkage enables clinical teams to review the quality of care delivered against patient outcomes and make improvements to how stroke patients are managed in the future. Having access to these data is therefore vitally important for quality improvement in stroke care which is in the public interest.

KCL are responsible for producing the CCG Outcomes Indicator Set (CCGOIS) measure of mortality at 30 days for stroke patients. Only by receiving the required data can these results be reported. These results are provided to NHS Digital to publish as part of the wider CCGOIS. The results are also provided at team level to provide necessary context on the performance of clinical teams treating stroke patients. As well as reporting on 30 day mortality, there is a need to show survival at other intervals such as at 6 months and 1 year. The outputs of the analysis by KCL will include mortality statistics at different time points and at different levels of granularity and dates of death will be used in statistical modelling.

The Civil Registration/Mortality data requested are for all patients in England and Wales since it is important to have complete, national level data on mortality to avoid selection bias and enable any socioeconomic or geographic factors impacting care received to be investigated. Only aggregate level mortality outputs are shared in the public domain with small number suppression in line with the HES analysis guide.

Objective for processing HES data

The HES data-set is used to determine the case ascertainment (case ascertainment is a measure of the number of cases reported in the audit, compared to the number of cases identified in HES) of participants of SSNAP, that is, the proportion of coded stroke patients which are recorded in the audit; and identify any re-admissions and further strokes, in order to compare quality of care with outcomes for patients. As the outputs of analysis of SSNAP are reported and publicly available, the proportion of patients entered into the audit for each hospital team, compared with the numbers in HES, is vital in determining how results are used (for instance, if there is low case ascertainment, the mortality outcomes would not be reported so that there is no potential misrepresentation).

Similarly without HES linkage it would not be possible to evaluate how complete or robust data submitted to SSNAP is, risking misrepresentation of results and how well or poorly hospitals are performing. HES linkage also facilitates additional important research to be undertaken on associated co-morbidities and outcomes after stroke, for e.g, increased association of dying from suicide after stroke or associations between dementia and stroke.

Service level (hospital) and CCG/LHB (Local Health Board) level outputs

Civil Registration/ Mortality Data and HES: Indicators will be produced showing the performance of organisations and at national level for the purpose of monitoring and quality improvement, in particular:

• Mortality within 30 days of hospital admission for stroke CCG Outcomes Indictor Set (CCGOIS) at least annually (first publication on 17 December 2014, next publication anticipated to be early 2019). The outputs generated at CCG/LHB level containing Civil Registration/Mortality data are: a CCG/LHB dashboard for each CCGOIS measure including 30 day mortality; a CCG/LHB public table of mortality including a funnel plot of results per CCG/LHB which are available here https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Mortality within 30 days of hospital admission for stroke Team-level mortality results (published in line with CCGOIS and used for contextualising the results). (Team usually equates to a hospital). The outputs generated at team (hospital level) containing Civil Registration/Mortality data are: a team level public table of mortality including a funnel plot of results per team which is available here: https://www.strokeaudit.org/results/Clinical-audit/National-Results.aspx

• Audit case ascertainment information included in quarterly and annual reports. Teams are assigned an A-E score based on number of patients submitted to SSNAP compared to expected figures as indicated by HES data.

• For statistical purposes such as monitoring trends approved clinical users (see explanation in SSNAP webtool section of processing activities)registered individuals at Trusts can access date of death for patients they submit to the audit derived from Civil Registration/Mortality data. This information is accessible to clinical users at participating teams via section 9 of the SSNAP webtool.

• No published reporting outputs contain patient identifiable information, only aggregate level information with small number suppression.

Timeline for report production:

Case ascertainment levels are a key component of many SSNAP reports. These reports are produced quarterly and case ascertainment is provided as both a total score and as a A-E banding depending on levels of data completeness. SSNAP’s quarterly outputs are disseminated to teams within 3 weeks of each quarterly data locking deadline.

Mortality reporting is undertaken at an annual level only. The timeline for generating mortality reports depends on accessibility of required Civil Registration/Mortality data. However once this has been made available to SSNAP the resulting outputs are produced and shared with clinical teams within approximately one month.

Dissemination of reporting outputs:

Dissemination of SSNAP results containing Civil Registration/Mortality/HES data follows an agreed phased approach. This means that clinical teams are initially provided with their own results for review and further analysis before reports are shared within the wider NHS domain and then finally released to the public. All published reports are hosted on the SSNAP website (www.strokeaudit.org) at aggregate level only and with suppression of small numbers in line with the HES analysis guide. It has been agreed that those teams responsible for submitting continuous data should have access to their own results before they are shared more widely. At the time of writing there are more than 4,000 registered users on the SSNAP webtool who are contacted when new results are made available. Website analytics reports (aggregated with small numbers suppressed) indicate that there are many thousands of website visitors accessing the results portal of the SSNAP website each month from the UK and across the continent.

Peer Reviewed Journals

Outputs produced using Civil Registration/Mortality/HES data are also disseminated in the form of peer reviewed research papers. Recent relevant publications include “Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry” “Associations between Stroke Mortality and Weekend Working by Stroke Specialist Physicians and Registered Nurses”. Full text versions are available here: www.strokeaudit.org/research. Again all journals only contain aggregated outputs with small number suppression in line with the HES anlaysis guide.

Presenting findings at clinician conferences

Published findings are often shared at national and international conferences For e.g at the recent European Stroke Organisation Conference SSNAP won the Paola De Rango Award for research into disparity of stroke care between men and women https://eso-stroke.org/eso/paola-de-rango-award-recognises-improving-stroke-care-access-for-women/

Traditional and new media dissemination

Results and reports are shared with stakeholders via press releases, newsletters, e-bulletins including those run by King’s College London and the Stroke Association, and twitter. Flyers have been created to provide simple, succinct information on how to interpret mortality results. Ebooks, audiobooks and online videos have been used to present results in accessible, innovative formats.

Patient Involvement

Stroke patient involvement remains at the heart of SSNAP’s work. The programme regularly meet patient groups to showcase reports and gain feedback about important issues for patients, while there are patient representatives seated on the ICSWP (The Intercollegiate Stroke Working Party) - SSNAP’s steering group. SSNAP also attends patient focused conferences across the country every year and more information about patient involvement, and flyers, leaflets and reports can be found at: https://www.strokeaudit.org/PatientInfo.aspx

Producing patient focused reporting outputs

SSNAP have drawn on extensive successful PPI (patient and public involvement) experience to date to ensure patient input is integral to reporting. For example, SSNAP’s existing Easy Access Versions (EAVs) of audit results were developed in response to feedback from and in collaboration with stroke survivors and carers in particular with Speakeasy – a charity based in Bury which supports people with aphasia - and the Stroke Research Patient and Family Group, based at King’s College London. SSNAP has and will continue to meet regularly with these groups to review the value and utility of EAVs and seek advice on the development of any new outputs.

SSNAP has also sought patient and public involvement in the development of an Annual Report. The development of this type of report has evolved over time by: being co-designed with the stroke survivor members of the ICSWP to ensure it covers issues of importance to stroke patients and their carers and families; featuring stories from stroke survivor and their families; including artwork created by stroke survivors. The latest annual report has focused primarily on stroke care quality improvement and includes case studies sourced directly from stroke survivors, emphasising the importance of QI (quality improvement) from a patient perspective. All four annual reports published to date are available on the SSNAP website www.strokeaudit.org/annualreport.

Acting on feedback received at patient groups and conferences; recent SSNAP Annual Reports have also used new media forms to maximise engagement with patients and carers. This has included: Ebooks, online interactive reports, and audiobook versions. The use of infographics and visualisations in the design maximises the impact. An indicator of public reaction and impact can be seen by the fact that the Annual Reports have been downloaded more than 100,000 times. It is invaluable as an exemplar of the potential benefits of this national audit.

Patient engagement at events and conferences

SSNAP have attended and presented at numerous patient focused conferences in recent years including the annual stroke club conference where the team have shared recent results, sought feedback on outputs and new forms of media communication such e-books and audiobooks and engaged with patient groups not previously aware of SSNAP. The team also attend the UK Stroke Assembly (North and South) every Summer to showcase SSNAP patient related materials and receive direct feedback from stroke survivors and carers.

Case ascertainment information from HES has been used to target trusts who were not achieving good levels of data entry to the audit in previous years, which has resulted in those trusts entering more records onto SSNAP, therefore improving the overall case ascertainment of the audit and reducing potential biases. This results in higher quality data being used for decision making at trust level and nationally.

Mortality information has been fed back to trusts in case-mix adjusted models, and outlier trusts have been identified. These trusts were contacted and encouraged to undertake case note reviews of their fatalities to identify areas for improvement. Outlying trusts were also offered a full peer review visit by the Stroke Programme, and a number of outlying trusts have taken up this offer to help identify where improvements in their service need to be made. The ability to adjust for variables such as stroke severity using the SSNAP Civil Registration/Mortality methodology is important, as stroke severity is a very strong predictor of mortality.

Statistical analyses of the HES and Civil Registration/Mortality data have looked at variation in stroke care and outcomes based on the presence of other diagnoses, socioeconomic status, and organisational characteristics of the hospitals treating the patients. Some of these analyses have already been published, and others are currently being written up for submission to peer review journals. In 2018 the paper ‘Socioeconomic disparities in first stroke incidence, quality of care, and survival’ was published in The Lancet. It is available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887080/. Such analyses have the potential to highlight key areas for improvement and to drive change.