Pre-hospital Research and Audit Network (PRANA)

University Hospital Southampton NHS Foundation Trust requires access to NHS England data for the purpose of the following research programme:

Pre-hospital Research and Audit Network (PRANA)

The following is a summary of the aims provided by University Hospital Southampton NHS Foundation Trust:

Each day across the UK, people become suddenly unwell or get injured; some so severely that their lives are immediately threatened. The NHS provides critical care to these patients outside of hospital. In 2023-2024, an estimated 40,000 patients were provided high level pre-hospital critical care to support their organ dysfunction to reach hospital care. Importantly, this type of care is also needed by patients in a major incident (e.g. mass casualty events). Data on trauma patients in recent military campaigns and international published meta-analyses of civilian data demonstrate a 2-3 fold reduction in death in patients receiving pre-hospital critical care versus patients of equal severity not receiving such care; demonstrating the huge potential of critical care delivery in the pre-hospital setting for these patients.

At present there is no nationally coordinated data collection regarding provision of pre-hospital critical care in the UK. Whilst patient specific data is collected by the ambulance services across their pre-hospital care pathway, data regarding pre-hospital critical care treatment is not currently collated beyond provider organisations nor linked to onward hospital treatment or outcomes. Therefore, the potential research opportunities and systematic improvements created through national data collection, analysis, review and publication are currently absent within UK pre-hospital critical care. This deficit within UK digital research infrastructure has been recognised by NHS England following their review of the Manchester Arena Inquiry recommendations. To analyse the ‘Care Gap’ described by Sir John Saunders’ Inquiry report, there is a clear need to link NHS and non-NHS multi-agency data across care pathways. In April 2024, the Chief Operating Officer for NHS England launched the Clinical Response to Major Incidents (CRMI) programme with pre-hospital data collection, multi-agency pathway wide linkage and data analysis as a core requirement for future research.

In response to this ongoing national challenge, the Pre-hospital Research and Audit Network (PRANA) has been established.

The aim of PRANA is to provide an England and Wales wide registry to support, manage, link, share and access data from critically ill and injured patients’ whole care pathways (from moment of recognition of illness or injury onwards) to enable and inspire novel life course data science research. The England and Wales wide PRANA registry will include all ages of medical and trauma patient (adults and children) who have received pre-hospital critical care. Immediate domains of novel research activity utilising PRANA are: epidemiology, pre-hospital critical care, ambulance service resource utilisation, major trauma care, major incident response and prevention of injuries and illness. The registry will include linkage of data from pre-hospital critical care provider services, ambulance services, national hospital critical care and trauma care registries, UK rehabilitation registry, Coroners, Police and Department for Transport.

Data held in the PRANA registry will be used for both research and non- research purposes as listed below.

Example research uses of the PRANA registry:

1.1 Define the case mix of patients receiving pre-hospital care, the supply of pre-hospital critical care and outcomes.

A national PRANA registry will for the first time enable definition of supply, demand and outcomes for current pre-hospital critical care services and describing the case mix of the patient population using the services across the UK.

1.2 Analyse the safety and efficacy of pre-hospital drug assisted advanced airway management for adult and child major trauma patients in the UK.

Advanced airway management is described in peer review journals as one of five priority international consensus areas for pre-hospital research. The National Institute for Health and Care (NICE) Major trauma guidelines advise that a severely injured patient (adult or child) who cannot maintain their own airway or whose breathing is ineffective should receive an anaesthetic and placement of a breathing tube, ideally before reaching hospital. This is called drug assisted tracheal intubation and is provided to major trauma patients as part of their care package an estimated 2000-2500 times per year in the UK. This recommendation from NICE is made based on expert opinion – as the UK does not have any national data on this subject, because there is no national registry.

1.3 To evaluate the end-to-end financial cost of road traffic collisions causing severe injury and death in England and Wales.

Considerable progress has been made in recent years in reducing the number of collisions (from 2.1 to 1.6 million 2013-2022) and police-reported injuries (from 150,000 to 105,000 2013-2022) on our roads – as reported by the Department for Transport (DfT) in their annual review of police data. However, in the same period, there has been no reduction in the number of deaths and only limited reduction of serious injuries (32,000 to 28,000 2013-2022 [DfT], 34,000 to 33,000 2001-2019 [Hospital event statistic data, England]). The cost of road traffic collisions is estimated by the DfT at £36 billion per year.

The current knowledgebase used to inform road safety policy and prevention of road traffic incidents utilises DfT data from the STATS19 and CRASH databases. There is no input from health services into these data. Casualty severity in STATS-19 is based on an assessment of injuries made by attending police officers who lack expert medical training and are unaware of how the patient’s injuries subsequently develop.

Example non-research uses of the PRANA registry:

2.1 Local service quality improvement

By providing ambulance service providers with the outcome data for the patients they have treated, PRANA will support quality issues to be addressed systematically and explicitly, providing reliable information. PRANA will support ambulance providers to confirm the quality of their clinical services and highlight the need for improvement.

2.2 Audit purposes

Clinical audit is a quality improvement cycle that involves measurement of the effectiveness of healthcare against agreed and proven standards for high quality and taking action to bring practice in line with these standards so as to improve the quality of patient care and health outcomes. The PRANA registry can be utilised to clinically audit measures of structure, process and outcome within pre-hospital critical care. Examples of these audits include:

2.2.1 Audits assessing the structure of pre-hospital critical care delivery, including

(1) audit of equitable access to pre-hospital critical care;

(2) case mix of pre-hospital critical care patients;

(3) staffing, skill mix and work force planning

(4) Public Health Outcomes Framework B10 – killed and seriously injured casualties on England’s roads. Accurate assessment of the effect of interventions aimed at reducing road traffic casualties.

(5) Public Health Outcomes Framework C11a and C11b - hospital admissions caused by unintentional and deliberate injuries in children and young people aged 0 to 24 years. Previously unrecognised targets for primary, secondary and tertiary prevention to reduce injuries in children and young people will become apparent.

(6) Public Health Outcomes Framework E03 - under 75 mortality rate from causes considered preventable. Influence reductions in the avoidable deaths in England and Wales.

2.2.2 Audits assessing the process of pre-hospital critical care delivery, including:

(1) NHS Outcomes Framework 5a - Patient safety incident reported - Accidental extubation required intubation in transit.

(2) NHS Outcomes Framework 5a - Patient safety incident reported - Complete ventilator failure.

(3) NHS Outcomes Framework 5a - Patient safety incident reported - Loss of medical gas supply.

(4) NHS Outcomes Framework 5a - Patient safety incident reported - Loss of all intravascular access.

(5) NHS Outcomes Framework 5a - Patient safety incident reported - Cardiac arrest.

(6) NHS Outcomes Framework 5a - Patient safety incident reported - Medication administration error.

(7) NHS Outcomes Framework 5a - Patient safety incident reported - Equipment failure or incompatibility impacting on patient care.

(8) Safety and effectiveness of pre-hospital emergency anaesthesia.

(9) Assurance of effective oxygenation delivery to major trauma patients.

(10) Adherence to NICE major trauma guidelines NG39, recommendation 1.2.3. Airway management in pre hospital settings.

(11) Adherence to NICE major trauma guidelines NG39, recommendation 1.2.3. Airway management in pre hospital settings.

(12) Adherence to NICE major trauma guidelines NG39, recommendation 1.3.2. Management of chest trauma in pre hospital settings. Consider using eFAST.

(13) Adherence to NICE major trauma guidelines NG39, recommendation 1.3.5. Management of chest trauma in pre hospital settings. Use open thoracostomy instead of needle decompression if the expertise is available.

(14) Adherence to NICE major trauma guidelines NG39, recommendation 1.5.22. Management of haemorrhage in pre hospital and hospital settings.

(15) Adherence to NICE major trauma guidelines NG39, recommendation 1.6.1. Reducing heat loss in pre hospital and hospital settings.

2.2.3 Audits assessing the outcomes of pre-hospital critical care delivery, including:

(1) mortality and survival data;

(2) creation of standardised mortality scoring systems for critically ill and injured patients;

(3) NHS Outcomes Framework domain 1a. Preventing people from dying prematurely. Quantify lost years longitudinally. Contribute to attempts to reduce years of life lost in the population of England and Wales;

(4) NHS Outcomes Framework domain 3.3. Proportion of people who recover from major trauma. Report what proportion of patients recover from major trauma having received pre-hospital critical care. This longitudinal information will support efforts to incrementally improve on this NHS outcome.

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) and HES Critical Care (HES CC) – necessary because patients who are critically ill or injured or those involved in road traffic collisions are admitted to hospital in England and Wales for specific episodes and the summary information for these episodes is included for patients admitted to normal wards and to intensive care units within HES.

> HES Accident & Emergency (HES A&E) and Emergency Care Data Set (ECDS) – necessary because patients who receive pre-hospital care often also receive emergency department care and the specific care provided by the emergency department is of significant consequence to the pre-hospital care provided. For example, if lifesaving care is provided immediately on arrival by ambulance to an emergency department, this could demonstrate that the patient had these same life support needs prior to reaching hospital and this enables the pre-hospital services to design better ambulance responses that fit the needs of patients. Another example is that the care that a patient receives in the emergency department following a road traffic injury is important to know so that assessment of the true burden of road traffic collisions is understood by the health system and broader society.

> Civil Registration Mortality – necessary because whether a patient dies or not is important for improving health systems. Linked data within PRANA will enable the ambulance services to review the occasions when patients who receive pre-hospital care subsequently die in hospital on the same episode.

> National Major Trauma Registry (NMTR) - NMTR data describes the most seriously injured patients who are treated in hospital. NMTR data describes the numerical scoring for traumatic injuries which standardises the description of serious injury. Public health policy for injury prevention relies on reviewing the severity of injury from specific mechanisms and therefore NMTR data is crucial to enabling correct analysis and interpretation for public health uses. The assessment of treatment modalities for trauma patients requires some assessment of how injured the patients were. NMTR data provides this objective assessment of the types, detail and scores for injury and therefore enables systematic assessment of the effect of treatments provided to patients. Into the future, the broader NMTR and TARN dataset will include a wider range of descriptors of the injury mechanism, treatments and outcomes. PRANA will link these data to detailed ambulance service data and to the HES, ECDS and mortality data. This linked dataset will enable detailed analysis of treatments recommended within NICE trauma care guidelines.

The field, ‘General Medical Practitioner’, has been included in this request because the name of the GP surgery for a patient is useful to PRANA for the purposes of analysing the demography of life-threatening disease in England and the points of access to community health care for the population who suffer life threatening disease. For example, the incidence of critical illness and injury in our communities may vary from rural to urban areas and may have a correlation with people's access to community care. The PRANA registry is the first time that pathway data for patients with critical illness presenting to the NHS ambulance service has been linked at scale to their outcomes and broader determinants of health. New insights into the organisation of our health systems may arise through understanding the socio-geographic distribution of disease and healthcare access.

The level of the Data will be:

> Identifiable – necessary to link data with the rest of the patient's care pathway.

The Data will be minimised as follows:

> PART 1:

Patients treated by ambulance service. This cohort covers individuals who were treated for a serious injury or illness, not just via road traffic collisions. For this cohort, data is only required from the time patient was first picked up by the ambulance service. An incident date per patient will be sent to NHS England at cohort submission to support this.

> PART 2

a cohort identified by NHS England, as meeting the following criteria:

- patients who have been involved in a road traffic incident, as identified by ICD10 and SNOMED codes.

- Patients identified in this cohort will be included from the first date where a qualifying ICD10 or SNOMED code was recorded, only data from this point onwards will be supplied

> Limited to data between:

- For cohort 1: 2016/17 to latest available

- For cohort 2: 1st January 2000 to latest available

University Hospital Southampton NHS Foundation Trust is the controller and sponsor as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

> Article 6(1)(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 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 Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3;

- Processing under Article 9(2)(h) will enable improvements in the prevention of disease and enable improvements in care delivery. PRANA will support accurate assessment of progress in addressing specific domains within the Office for Health Improvement and Disparities Public Health Outcomes Framework (PHOF) and support recognition of further intervention targets for improving these Outcomes, and will support the NHS Outcomes Framework by enabling longitudinal review of the critical incidents or complications and any adverse outcomes occurring nationally when pre-hospital critical care is delivered to medical and trauma patients.

> Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject;

- Processing under article 9(2)(j) will enable a longitudinal registry of patient care for research and non-research purposes. PRANA will enable a description of the number of medical and trauma patients being treated at present by pre-hospital critical care teams. This is currently not known accurately and estimates are based on extrapolation of regional data. This would provide the background information to determine whether equitable access to pre-hospital critical care exists in England and Wales and over years would support the ability to monitor and stimulate progress towards equitable access.

This processing is in the public interest because it will enable improvements in the prevention of disease, road traffic collisions is an example. The processing will enable improvements in care delivery, an example is airway management within pre-hospital care and will enable a longitudinal registry of patient care for research.

The funding comes from multiple sources. Current funders include:

> Wessex Secure Data Environment programme

> Wessex Health Partnership (WHP)

> Wessex Experimental Medicine Network (WEMN)

> Road Safety Trust (RST)

Funding to continue the work described will be sought on an ongoing basis.

The funders will have no ability to suppress or otherwise limit the publication of findings.

The University of Southampton (UoS) is a processor acting under the instructions of University Hospital Southampton NHS Foundation Trust. The UoS's role is limited to running the SDE where the Data will be stored.

Telefónica Tech UK Limited provides IT hosting services via the Microsoft Limited Azure cloud to the UoS and will store the Data as contracted by the UoS.

The following organisations have advised on what Data could be useful to answer particular questions:

 NHS England Emergency Preparedness, Resilience and Response (EPRR) Clinical Reference Group,

 The Faculty of Pre-Hospital Care,

 Air Ambulance services across the UK

The PRANA advisory committee has representation from :

 NHS England Data Access and Partnerships

 Department for Health and Social Care Policy

 Department for Transport

 Office of the Regulator of Statistics

None of the organisations listed above have any role in determining the purpose or means of data processing. These organisations’ role is limited to providing advice only.

The development of the PRANA registry has been informed at all stages through input from patients and families treated by pre-hospital critical care teams. Specifically, the plans for PRANA and the data linkage that PRANA would like to enable, have been presented to patients and families at engagement events in October 2021, October 2022, February 2023, September 2023 and February 2024. Feedback from patients and families has been highly supportive of data linkage for the purposes of improving the care provided by services, understanding more about disease and preventing disease. PRANA has a patient, family and public engagement group composed of members of the public and patients who received pre-hospital critical care following medical and traumatic events, families of patients who received pre-hospital critical care and families of patients who died before reaching hospital.

In addition, PRANA is an exemplar project within the Wessex SDE programme. The public and patient involvement and engagement work that the Wessex SDE has undertaken has explicitly included discussion of the use of patient identifiable information without consent and explicitly used PRANA as an example case study. This work has contacted 759 members of the general public.

PRANA's PPIE work has also reached the NHS England’s Core20PLUS5 and Joint Strategic Needs Assessment (JSNA) target categories, with 260 people receiving the talk and approximately 90 engaging in post-talk discussions. Their seldom heard groups engagement programme has directly tested whether the groups found it acceptable that their identifiable patient information (with the safeguards we have in place) will be used to link the data for use within the SDE. The PRANA programme was utilised as a case study for this engagement. The discussion included clear reference to the fact that patient information will be transferred to the SDE from a number of sources where it will be linked, but that confidential patient information will be kept private from research users of the SDE platform. The PRANA team explained that privacy will be ensured through de-identification of data, and discussed the processes by which this will be achieved. The other ‘Five Safes’ that will be applied to data processing by the SDE were also discussed. PRANA's seldom-heard groups engagement was tailored to ensure that the complex issues were explained simply and straightforwardly to public participants, who may have lower levels of data literacy and confidence.

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Sub-licensing

University Hospital Southampton NHS Foundation Trust will promote and make possible wider use of these data under sublicensing arrangements subject to the following access arrangements.

The below sublicensing arrangements are specific to the research uses of the PRANA research database

Applications for data access are submitted using the ‘Wessex SDE data access request form’ and submitted to the Wessex SDE Data Access Committee (DAC). The data access request approvals process is as follows:

1. Application will be submitted outlining the objectives, methods, and data requirements.

The proposal is reviewed by DAC and the following points considered:

• The Legal basis for requesting data

• The type of data access request

• Risks for individuals of data access

• Ethical support for data access

• Risk of reidentification of individuals

• The cohort of interest

• Safe project – methodology review

• Selection bias

• Dissemination and publication plan

• Benefit of data access and analysis for the NHS and wider health

• Public benefits of project

• Safe people assessment

• Safe Settings assessment

• Safe output assessment

The NHS SDE network policy on user and organisation validation will be used to assess the organisations and users applying for data access.

2. Once approved by DAC, the researcher requesting access will sign the Research Programme Agreement (RPA) and apply for a Wessex SDE ‘Researcher passport’ using the research passport application form.

3. Once the RPA has been signed, the sublicensee submits a formal request to access the data, outlining the specific data they need, and how it will be used in line with the programme's goals

4. Programme-Specific Agreement- After registration, researchers sign an additional agreement for each specific programme they wish to participate in. This agreement:

o Details their role and responsibilities.

o Outlines access and usage of the data.

o Specifies sanctions for misuse, in addition to those under the general Research Programme Agreement.

5. Before gaining access to data, researchers complete mandatory information security training, ensuring they understand how to handle data responsibly and securely.

6. Data will be made available to the sublicensee within the Wessex Secure Data Environment (SDE). This SDE meets NHS England accreditation for Secure Data Environments and Undergoes regular penetration testing by external security providers to ensure its robustness

7. Each sublicensee is assigned a separate 'workspace', this will comprise of only the data they required to achieve their stated aims

8. Before access is granted the sublicensee will need to verify they are a registered researcher (Via UKDS).

9. Once approved, researchers are granted access to their specific programme workspace via a Virtual Desktop Interface (VDI). Data cannot be extracted from this environment and all data is pseudonymised.

The anticipated numbers of national colleagues applying for access to linked PRANA data through the Wessex SDE Data Access Committee is thought to be fewer than 20 per year. The type of organisations requesting data access is expected to be universities, NHS trusts and charities. Applications for requests with a commercial element will not be accepted by the DAC.

The University Hospitals Southampton NHS Foundation Trust will transfer data to NHS England.

The data will consist of identifying details (specifically NHS number, Date of birth, first and last name, postcode, Gender and Study ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES, ECDS and deaths datasets to University Hospital Southampton NHS Foundation Trust. The Data will contain directly identifying data items including NHS Number, Date of Birth and Gender which are required to link the Data at record level with data already held by the recipient.

The Data will not be transferred to any other location.

PRANA has two components within the Wessex sub-national Secure Data Environment:

(1) The PRANA registry - held within the data processing environment of the Wessex SDE. Contains identifiable data. Only accessible to University Hospital Southampton NHS Foundation Trust staff. The Department for Transport (DfT) will also have access to identifiable postcode, as the DfT STATS-19 database utilises the patient’s home postcode as a key component of their identification of records and this is therefore fundamental for linkage.

(2) The PRANA research database - held within the data processing environment of the Wessex SDE. This is a pseudonymised research data base. Available to approved sublicensees.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to employees of University Hospital Southampton NHS Foundation Trust who have authorisation from the head of information governance at University Hospital Southampton, and approved sublicensee organisations.

Identifiable data will be managed in the 'data processing environment': a separate area of the Wessex SDE. The only persons with access to this area will be designated members of the Wessex SNSDE technical team, part of the wider Digital Team within University Hospital Southampton NHS Foundation Trust. Access to the data processing area of the secure data environment, and hence to patient-identifiable data within the scope of this Agreement, will be restricted to designated members of the SDE technical team.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with Coroners’ report data obtained from Coroners services, STATS-19 and Road Accident In Depth Studies (RAIDS) data obtained from the Department for Transport, Out of hospital cardiac arrest registry (OHCA) data obtained from Warwick University, Organ donation national registry data obtained from NHS blood and Transfusion, road traffic collision data from the Police, and Paediatric Intensive Care Audit and Research Network (PICANet) data obtained from Leeds and Leicester University Intensive Care National Audit and Research Centre (ICNARC).

The Data will not be linked with any other data.

The identifying details will be stored in a separate area to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. However, if a danger to the patient is identified, the patient may be identified in order to flag this.

Access and activity within the data processing environment will be recorded, and the records or audit logs appropriately protected.

Analysts from University Hospital Southampton NHS Foundation Trust and approved sublicensee organisations will analyse the Data for the purposes described above.

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Sub-licensing

The below sublicensing arrangements are specific to the research uses of the PRANA research database

Data will be collated as per the requirements specified in the RPA and made available to the sublicensee in their assigned ‘workplace’ within the SDE

Researchers are not able to extract data from the SDE, they may move data into the AIRLOCK space, and any outcomes (aggregate small numbers supressed) may be extracted once reviewed and approved by data science leads from Wessex SDE.

Activity within the SDE will be monitored and recorded. A copy of any code or reference data imported, and of any results exported, will be retained to support auditing and reporting, and in case of any subsequent dispute.

The RPA will include provisions regarding publication; compliance will be monitored by the Wessex SDE management team.

Researchers will not be asked to flag any potentially clinically significant findings in individual patients. If a researcher asks a question or raises an issue regarding a particular data set, one that may have some bearing on the care received or the care required for a particular group of patients, then this will be reviewed by the SDE team, including the PRANA chief investigator and may be shared with the NHS organisations that supplied the data in question. No re-identification of individuals will occur within the researcher-accessible TRE – this will only be possible within the organisation directly responsible for that individual’s clinical care. This provision is only expected to be used in exceptional circumstances where it is felt that the safety of an individual is at risk.

The PRANA chief investigator will take responsibility for communicating with the source NHS organisation’s medical leadership team to ensure that the information is assessed in a timely and patient centered fashion.

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Providing linked pre-hospital pathway data to Intensive Care National Audit & Research Centre (ICNARC), Paediatric Intensive Care Audit Network (PICANet) and NHS Organisations

NHS Ambulance services and Air Ambulance services treat critically injured and ill patients and deliver them to hospital. The onward course of each patient treated is currently completely unknown to the ambulance services and air ambulances. This prevents the ambulance services and air ambulances from accurately assessing the efficacy and safety of the care that they have provided to patients. This local audit and quality improvement activity is significantly contstrained through the absence of onward information about the paitints’ care. The PRANA registry will enable linkage of ambulance service patient data to the onward care pathway data for the patient. Providing this linked data back to the specific ambulance services and air ambulances that treated the patient will enable each service to properly apply governance to the care they provide to patients.

Patients treated within NHS hospital intensive care units have their care data recorded within the national registries called ICNARC and PICANet. These registries are blinded to the care that was provided in the pre-hospital phase. Meaning that patients that had identical care pathways once they reached hospital could have completely dissimilar care pathways for their ambulance service care. For the national registries, assessing the standard of NHS care provided to intensive care patients, knowing the initial apre-hospital care provided to their patients is an essential (and currently missing) part of the information needed to fairly and standardly assess the outcomes of patients. Providing linked pre-hospital pathway data to ICNARC and PICANet will enable these registries to have a full view of the care delivered to patients along their care pathway and enable them to update their standardised mortality prediction scoring systems.

Identifiers will be held in the Data Processing Environment (DPE, known as the PRANA registry) but not the researcher-accessible Trusted Research Environment (known as the PRANA research database). Identifiers are needed within the DPE to ensure consistent linkage of data to unique individuals to reduce the risk of duplication, or incorrectly linking data from multiple datasets to the wrong individual. Failure to do this risks the integrity of any research results from the SDE. It is not feasible to do this linkage at each host provider site, hence the need to transfer identifiers with the clinical data.

Each organisation providing data to the PRANA registry will have their own algorithm to encrypt the data, with a key. Therefore, each organisation will have different encryption keys. The SDE environment needs to link patient data from across organisations since individuals may be treated in different locations over time, this will provide researchers with a complete longitudinal view, if required. Keys are held in a secure area within the Data Processing Environment, with highly controlled access by named members of the Wessex SDE Team. These keys are only available for reidentification with the written agreement of the data controller. The linkage of data using the identifiers will be performed in a defined area within the data processing environment. The data will subsequently be pseudonymised, and identifiers will be removed from all subsequent data processing steps.

PRANA explicitly needs to link to other registries using patient identifiable data – to enable audit and clinical service improvement activity. The linkage will occur within the Data Processing Environment of the Wessex SDE and data will be pseudonymised to create the PRANA research database from which specific data will be made available within a trusted research environment.

The data extracts that are made available for analysis within the TRE will contain no direct identifiers. The data will be organised using fresh identifiers generated for the research project in question. The association between the original identifiers and these fresh identifiers will not be held in the TRE; it will be stored separately, within a KeyVault that cannot be accessed directly, even by the Wessex SDE data team data team without express written authorisation by the data controller.

Prior to the data being released to the researchers in the Trusted Research Environment, a number of checks will take place in the Data Processing Environment to ensure that no identifiers are contained in the data. Many of these checks are automatic within the system. Prior to release, a member of the Wessex SDE Team will undertake a review of the data being released and grant or deny access to the researcher to the data held in the Secure AIRLOCK.

The expected outputs of the processing will be:

> Submissions to peer and non-peer reviewed journals, supporting widespread knowledge of the utility of the PRANA registry and of the process for accessing the registry data

> Regular general report published on the PRANA website

> Specific report to the patient, family and public forum

> Specific feedback to ambulance services

> Specific feedback to NHS England Emergency Preparedness, Resilience and Response (EPRR)

> Presentations on activity, progress and key messages each year at national professional clinical and research conferences, ensuring that NHS and third sector providers within and outside of hospitals are updated with PRANA activity.

> System Learning: The technical and governance lessons from the expansion of PRANA to become a national registry will be shared with the NHS England Secure Data Environment programme. Utilising whole patient journey data from the PRANA registry, the PRANA team will support the DfT strategy team to inform national transport policy with an aim of reducing preventable deaths and disability.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to the public, patient representative groups, clinicians, researchers, pre-hospital leaders, policy makers and colleagues around the UK through the following dissemination channels:

> Journals

> Conferences

> Reports aimed at patients, families of the patients, and the public

> Social media and website updates: Information regarding the UK wide PRANA registry will be available for the public and professionals at www.prananet.org

> Information on activity, progress and key messages will be shared through the UK national pre-hospital care patient and family forum

> PRANA activity, progress and key messages will be shared with the NHS national clinical directors for trauma, emergency preparedness, critical care and emergency care. This will enable a strategic assessment of the utility of linked data for the NHS.

Outputs will be produced on an ongoing basis, for as long as there is continued support and patient need for PRANA.

Examples of research benefits of the use of the PRANA registry:

1.1 Define the case mix of patients receiving pre-hospital care, the supply of pre-hospital critical care and outcomes.

This will support healthcare professionals to understand what works for critically ill and injured pre-hospital patients in the UK, the risks that patients and clinicians are exposed to and how to iteratively reduce risk. This baseline information will support healthcare planning, quantify resource requirements, support resource allocation, allow local and national service evaluation and support refinement of the criteria for ambulance service tasking of critical care assets.

1.2 Analyse the safety and efficacy of pre-hospital drug assisted advanced airway management for adult and child major trauma patients in the UK.

The safety and effectiveness of this intervention for adults and children is measured by local services, however there is zero ability to assess this intervention across the country, at present. Successful creation of a national PRANA registry will enable systematic analysis of pre-hospital advanced airway management in the UK, for the first time. Data will be categorised into adults (age 16 years and older) and children aged 15 years and younger). This definition is based on that used by major trauma systems to flow new patients.

1.3 To evaluate the end-to-end financial cost of road traffic collisions causing severe injury and death in England and Wales.

The PRANA registry linkage of patients to STATS-19 data provides a significant step change for public health in the UK. It will enable a more accurate assessment of the cost of road traffic collisions by including healthcare in the calculation. According to the DfT and the Transport Research Laboratory, demonstration of the true impact of road traffic collisions on UK society would provide the evidence to influence road safety policy and support prevention of road traffic collisions. In this way, the prevention aspect of PRANA could be its most consequential contribution to improving human health. Economic analysis of the cost of road traffic collisions would be achieved in collaboration with Department for Transport colleagues using the Willingness to Pay model economic model.

Examples of non-research benefits of the use of the PRANA registry:

3.1 Audit assessing the structure of pre-hospital critical care delivery

3.1.1 Audit of equitable access to pre-hospital critical care

PRANA will enable a description of the number of medical and trauma patients being treated at present by pre-hospital critical care teams. This is currently not known accurately and estimates are based on extrapolation of regional data.

This would provide the background information to determine whether equitable access to pre-hospital critical care exists in England and Wales and over years would support the ability to monitor and stimulate progress towards equitable access.

3.1.2 Case mix of pre-hospital critical care patients

PRANA will enable a description of the number of patients in each disease category (case mix) treated by pre-hospital critical care teams. This has never been described before for England and Wales. Understanding the diseases that are currently being treated and the treatments provided, will support recognition of domains of improvement for specific diseases. PRANA will then be able to year on year provide quantitative assessment of the impact of interventions to improve care.

3.1.3 Staffing, skill mix and work force planning

PRANA will enable a description of the staffing of pre-hospital critical care delivery across England and Wales and the interventions that these staff provide to patients. This information is not currently available and its absence significantly constrains service planning.

The information would be used to inform the development of national training programmes for specialist and advanced nurses and paramedics within the domain of pre-hospital critical care.

The information would be used by the Intercollegiate board for Training in Pre-hospital Emergency Medicine to inform work force planning and calculate the number of Pre-Hospital Emergency Medicine sub-specialty trained doctors that are needed nationally to sustain service provision.

3.1.4 Public Health Outcomes Framework

PRANA will support accurate assessment of progress in addressing specific domains within the Office for Health Improvement and Disparities Public Health Outcomes Framework (PHOF) and support recognition of further intervention targets for improving these Outcomes.

PHOF Domain Output from PRANA:

PRANA plans to link health data and Department for Transport data, which would enable the first accurate description of the number of patients killed and seriously injured in road traffic collisions in England and Wales and their outcomes. This would enable accurate assessment annually of the effect of interventions aimed at reducing road traffic casualties.

Linkage of health and transport data will support the recognition of primary, secondary and tertiary prevention targets to reduce future road traffic casualties. The most tangible of these primary prevention targets is the association of road vehicle velocity and severity of injury. PRANA will be able to provide the speeds of vehicles and the associated injuries to patients. This is currently not possible in England and Wales. Such data integration would support transport policy to be designed to minimise injuries to humans.

PHOF Domain Health improvement:

Through PRANA linking pre-hospital care, transport and final outcome data, it is possible that new previously unrecognised targets for primary, secondary and tertiary prevention to reduce injuries in children and young people will become apparent.

Through the linkage of health and Transport data, described above and the effect on integrated transport and health policy, PRANA hopes to influence reductions in the avoidable deaths in England and Wales.

3.2 Audits assessing the process of pre-hospital critical care delivery

3.2.1 NHS Outcomes Framework

PRANA will support the NHS Outcomes Framework by enabling longitudinal review of the critical incidents or complications and any adverse outcomes occurring nationally when pre-hospital critical care is delivered to medical and trauma patients. This has previously never been achieved within England and Wales. This would enable annual reporting of regional complication rates and provide objective information to inform year on year attempts to reduce complication rates.

Outcome Framework output from PRANA:

3.2.2 Safety and effectiveness of pre-hospital emergency anaesthesia

PRANA will enable audit of the safety of pre-hospital emergency anaesthesia for medical and trauma patients against the national guidelines produced by the Association of Anaesthetists (AAGBI) standards for pre-hospital anaesthesia. This will enable service improvement across the country to be driven by longitudinal data.

3.2.3 Assurance of effective oxygenation delivery to major trauma patients

PRANA will enable audit of oxygen saturations of major trauma patients who receive pre-hospital critical care. This would enable recognition of failures to oxygenate and provide an evidence base to support incremental improvements in assurance of oxygenation for patients. This would respond to the concerns raised in the NCEPOD ‘Trauma who cares’ confidential enquiry (2007) regarding widespread hypoxaemia in trauma patients.

3.2.4 Adherence to NICE major trauma guidelines

PRANA will enable audit of the care quality provided by pre-hospital critical care teams for seriously injured patients measured against the NICE guideline NG39: Major trauma: assessment and initial management.

Aim to perform RSI (pre-hospital anaesthesia) as soon as possible and within 45 minutes of the initial call to the emergency services, preferably at the scene of the incident.

By reporting the accurate current times to provide pre-hospital anaesthesia against the NICE national recommendations, it will be possible to highlight factors to improve achievement of this recommendation and track improvement across the years.

PRANA will enable the use of near patient ultrasound in trauma to be quantified nationally – as this is provided by pre-hospital critical care teams. Because PRANA has the timing information for the flow of the patient through the emergency medical system, it will be possible to report against this national recommendation.

PRANA will enable an incidence rate for these procedures to be described for the first time. Quantification of adherence to the national recommendation will then be possible serially.

PRANA will be enable reporting of the use of volume replacement fluids within pre-hospital critical care and the correlate this to the presence of active bleeding. Therefore, with the integration that PRANA enables, this national recommendation will be testable.

PRANA will be able to report the temperature profiles for patients receiving pre-hospital critical care and the thermal management package associated with these profiles. Improvement in care will be supported through longitudinal review of data against the NICE recommendation.

3.3 Audit assessing the outcomes of pre-hospital critical care delivery

3.3.1 Mortality and survival data

PRANA will enable, for the first time, a description of the unadjusted mortality and survival for patients receiving pre-hospital critical care in England and Wales. Patients with similar disease and similar severity could then be compared. 2 immediate examples are trauma patients with specific injury severity scores or cardiac arrest patients with particular cardiac rhythms.

This information would provide the baseline to develop a standardised mortality ratio (described below). Comparing adjusted mortality and survival would enable the care provided to patients in each region to be fairly compared longitudinally across years and support the development of targets to achieve progressive mortality reduction.

3.3.2 Creation of standardised mortality scoring systems for critically ill and injured patients

Hospital based critical care and trauma systems utilise standardised mortality ratios to describe the likelihood of death given specific physiologic and anatomic disease. Separate and specific models are used by TARN, ICNARC and PICANet to assess trauma patients, adult intensive care patients and paediatric intensive care patients respectively. These models enable systems of care to be assessed for the presence of unexpected deaths and unexpected survivors. This knowledge has driven incremental improvements for in-hospital care pathways. Current standardised mortality scores exclude pre-hospital physiology and anatomy entirely. In collaboration with TARN, ICNARC and PICANet, analysis of the linked physiological data within the PRANA registry will enable assessment of the impact of pre-hospital physiology and anatomy on mortality. This would enable creation of new and potentially more accurate standardised mortality models which assess whole care pathways rather than just the in-hospital component. If these models prove effective, they will enable objective analysis of a previously unquantifiable domain of national care provision; supporting systematic and incremental care pathway improvements.

Achieving longitudinal collection and analysis of mortality and survival data for pre-hospital critical care would approach the NHS Outcomes Framework.

Outcomes Framework PRANA output:

For both adults and children, PRANA will for the first time describe the death and survival rates for patients receiving pre-hospital critical care. By enabling these data to be analysed and interpreted, PRANA will fundamentally contribute to attempts to reduce years of life lost in the population of England and Wales and be able to quantify this over the years.

The linkage of care pathway data from pre-hospital care into hospital care for England and Wales has never been achieved. Therefore, at present in England and Wales there is very limited ability to quantify the effect of pre-hospital critical care on the survival of major trauma patients to recovery. PRANA will be able to report what proportion of patients recover from major trauma having received pre-hospital critical care. This longitudinal information will support efforts to incrementally improve on this NHS outcome.

The linked data is expected to be used for analysis of paediatric critical care, blood transfusion and sepsis in 2026.

Expected benefits using NMTR data:

An example is the use of injury severity scores from NMTR to quantify the impact of road traffic collisions on the population. With NMTR data it will be possible to describe for the first time the number of people with different severities of injury who are involved in road traffic collisions and link this to the Department for Transport road traffic collision data. The NMTR data will enable the DfT to view the implications for people, measured in injury severity, from road traffic collisions across time. This is supportive of the Office for Health Improvement and disparities public health outcomes framework.

The use of the data could:

- help the system to better understand the health and care needs of populations.

- lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

- advance understanding of regional and national trends in health and social care needs.

- advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions

- inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

- inform decisions on how to effectively allocate and evaluate funding according to health needs.

- provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

- support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

PRANA have linked the NHS England Data to ambulance service records and to the Department for Transport (DfT) road traffic collision data.. This linked data is being utilised by the DfT Road Safety Statistics Team to assess the effects of road traffic collisions on patients health and health care requirements. The DfT have passed through the Data Access Processes for the Wessex SDE and only have access within the SDE to anonymised specifically described data. They will use the output form their analysis to inform the delivery of the national road safety strategy. The PRANA programme was specifically named in the National road safety Strategy in January 2026 as the method for linking NHS England data and DfT data.