COVID Oximetry At Home - (CO@H): Imperial

The COVID Oximetry @home (CO@H) programme involves the remote monitoring of patients with coronavirus symptoms. Patients use a pulse oximeter, a small monitor clipped to their finger, to measure their oxygen saturation levels three times a day. They record their results using a smartphone app, web portal or paper diary. The paper-based option is available at all sites for patients who are uncomfortable with or unable to use a digital solution to record their readings. Patients are supported by clinical staff locally, so that if they need further treatment they can be admitted to hospital at the right time. Currently, services are delivered by a range of provider organisations, including Clinical Commissioning Groups, Primary Care Networks and acute hospital trusts. Following a successful pilot evaluation - conducted in-part by Imperial College London - NHS England, NHS Digital and NHSX are collaborating on the national implementation of this service, called COVID Oximetry @ Home (CO@H). In November 2020 it was agreed to extend the service across England from 1st December 2020 to date https://www.england.nhs.uk/nhs-at-home/covid-oximetry-at-home/.

In addition to Imperial College London, the CO@H evaluation consists of three other organisations working independently on separate programmes of work which collectively evaluate the qualitative and quantitative aspects of delivery of the CO@H service. A team from University College London (UCL) and the Nuffield Trust will qualitatively evaluate the CO@H service through a range of survey and interview studies and will also undertake evaluation of the effectiveness of the CO@H programme using aggregated data (with small number suppression applied), while the Improvement Analytics Unit (IAU) of the Health Foundation will evaluate the effect of the CO@H programme on patient outcomes.

Imperial College London are the data processor and have been asked by NHS England (who are the data controller for the study) to evaluate the implementation of the CO@H service to identify emerging issues relating to safety or equity of the service as it is implemented. To undertake this evaluation, Imperial College London require patient-level pseudonymised data for patients enrolled into the CO@H programme, and also for patients not enrolled in the programme either before or after implementation. Imperial College London will be responsible for providing quantitative evaluation of the CO@H service according to three different analytical strategies described in section 5b. Additionally, Imperial College London will provide the Nuffield Trust with data aggregated at the level of the Clinical Commissioning Group with suppression of small numbers (<=5) in order to enable their evaluation of the CO@H service as detailed in 'Processing Activities - Section 5b'.

The purpose of this work is derived from the need to evaluate national roll out of the NHS England Covid Oximetry @Home (CO@H) programme. The aim of this work is to quantitatively assess the cost effectiveness and clinical effectiveness of the CO@H intervention as well as variation in access and outcomes. The data requested is uniquely capable of achieving this aim as it contains necessary information about patients who are enrolled onto the CO@H programme as well as their outcomes. Furthermore, the data requested will support critical analysis regarding inequalities to accessing the pathway, patient-level outcomes after being onboarded into the pathway and CCG-level performance of the CO@H programme. Only this data, inclusive of the requested variables, will be able to support these analyses and therefore achieve the aim identified.

The data is required for service evaluation purposes - meeting the conditions outlined as per Article 9 (2)(H) of the GDPR. “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”. Imperial College London are carrying out service evaluation work (under the instruction of NHS England) as described in this agreement to investigate how the quality of care can be improved.

As such, this work is of significant public health concern undertaken by a service evaluation team conforming to General Data Protection Regulation (GDPR) Article 6(1)(e) and Article 9(2)(H).

The quantitative evaluation of CO@H requires understanding the clinical outcomes of patients onboarded into the CO@H programme as well as key features of their medical history. These datapoints are included in the data collection specification and directly enable an evaluation of the CO@H programme which would not be possible with any other data. Given the unprecedented need to understand how best to manage Covid-19 in the community, the data required for this evaluation will enable a statistically robust analysis which can inform and direct national policy making.

The anticipated cohort size for this evaluation will be c3,7 million people - including those with a CV19 Positive Test (control) and those on the CO@H Programme (case).

For this dissemination - the legal basis to disseminate the data is the Control of Patient Information Notice (COPI) Regulations. NHS Digital has chosen to pseudonymise the confidential information in accordance with the COPI regulations.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e: employees, agents and contractors of the Data Recipient who may have access to that data).

Processing this data is in the public interest as it will provide evidence as to the clinical effectiveness of home oximetry as a clinical pathway for patients with Covid-19. This evidence will support the health service to more effectively treat and manage Covid-19, and therefore is of substantial public interest. The data will be analysed within Imperial College London Big data and Analytical Unit Secure Environment (BDAU SE), an ISO 27001 research environment with strictly controlled access policy. secure environment. The programme and it's evaluation work-streams has been reviewed by the Imperial College Research Integrity Office, which concluded that it did not require ethical approval. Furthermore, Service Evaluation Approval also noted the lack of ethical concerns. The evaluation will be conducted using pseudonymised data entirely, and therefore there is minimal risk of identification. Given the size of the dataset request, it would not be reasonably feasible to seek individual consent for this project.

The purpose of this work is derived from the need to evaluate national roll out of the Covid Oximetry @Home (CO@H) programme. The aim of this work is to quantitatively assess the cost effectiveness and clinical effectiveness of the CO@H intervention as well as variation in access and outcomes. The data requested is uniquely capable of achieving this aim as it contains necessary information about patients who are enrolled onto the CO@H programme as well as their outcomes. Furthermore, the data requested will support critical analysis regarding inequalities to accessing the pathway, patient-level outcomes after being onboarded into the pathway and CCG-level performance of the CO@H programme. Only this data, inclusive of the requested variables, will be able to support these analyses and therefore achieve the aim identified.

This request supports a funded programme of work, commissioned by NHS England, with additional funding from the National Institute for Health Research (NIHR), with data co-ordination provided by NHS Digital. It was initially intended to be a six-month piece of work beginning in December 2020 and due to finish in May 2021.

* Update 18/08/2021* - the project was extended from the initial endpoint of May 2021 to September 2021. An extension is therefore required to the data sharing agreement to incorporate analysis of final results and the peer review publication process.

*Update 16/03/2022* - Owing to delays in the peer review process for publication of evaluation findings in academic journals, a further extension is therefore required to the data sharing agreement to incorporate the peer review publication process.

The proposed evaluation work is overseen by the CO@H evaluation working group led by NHS England. The working group has contributed to a common understanding of the evaluation needs, as well as worked-up a CO@H specific dataset for evaluation purposes. This dataset, common across studies led by Imperial and the Health Foundation, is what is described in this application. Although both Imperial and the Health Foundation will lead on their own work and evaluation stream (and as such apply for these data separately), there is commitment to share learning between the two pieces of work to ensure robust findings, a common definition of key metrics, and improved efficiency in tackling any issues arising from the data. The intent is to share the outputs of the work to the general public in the form of peer reviewed publications in open access journals in addition to reports to NHS England and other forms of dissemination.

This evaluation will use routinely collected data from patients who have tested positive for COVID or are clinically suspected of having COVID and have been enrolled into the CO@H programme. Eligibility criteria for the programme include those aged over 65 years of age or identified as Clinically Extremely Vulnerable. Additionally, clinical judgment is encouraged for those outside of these eligibility criteria and will NOT include patients under the age of 18. These data will be used comparatively, by comparing against patients testing positive for COVID, but not in receipt of the CO@H programme.

The purpose of this work is derived from the need to evaluate national roll out of CO@H. The purpose of this work is to quantitatively assess the cost effectiveness and clinical effectiveness of the CO@H intervention as well as variation in access and outcomes.

Work package 1: Identifying inequalities in access in CO@H

Objective 1:

To identify inequalities in access to the CO@H programme based on location, demographic and clinical traits.

Methods used:

• In the first work package, all patients with a positive Covid test from the date of implementation of CO@H in each site will be included.

• The probability of inclusion in CO@H conditional upon being eligible for the program based on features in GDPPR will be examined across a range of regional, demographic and clinical features.

• Binary logistic regression will be used to identify statistically significant differences in likelihood of inclusion according to these features nationally, and where possible at the level of individual sites.

• Some patients not onboarded onto CO@H may have been too unwell for onboarding, and so may not provide a suitable comparator group. A range of sensitivity analyses will be conducted to examine different assumptions relating to whether mortality or hospital presentation around the time of testing precluded enrolment, using secondary care and ONS mortality data. The ability to undertake this component will be determined by the availability of both date of test and date of result for Covid tests.

• Absence of oxygen saturations for those not onboarded precludes comparison of clinical acuity in the community.

Output:

• This work package will deliver ongoing regular surveillance of the occurrence of inequality in access to CO@H in relation to geographic or demographic traits

5.2 Work Package 2: Quantifying the Impact of CO@H on Patient Outcomes and Secondary Care Utilisation

Objective 2:

To identify national and site-specific mortality and secondary care utilisation effects of CO@H on patients with a positive Covid test result

Methods used:

• This evaluation examines the effect of the CO@H programme on those individuals eligible for the programme and those not eligible for the programme. Outcome measures will include A&E presentation, hospital admission, ICU admission and mortality.

• Propensity score matching will be used to match pre and post implementation populations testing positive for Covid according to known demographic and clinical features extracted from GDPPR. Additionally, local measures of Covid incidence and nearby secondary care burden will be incorporated into the matching.

• In addition to reporting the effect of the intervention on the eligible population, the evaluation will be repeated for those not eligible for CO@H based on the above criteria derived from GDPPR. This will identify any ‘background’ trends in disease severity and mortality in the population not eligible.

• Depending on the characteristics of implementation across sites, post-implementation analysis may begin after a transition period determined according to whether sites implement from a standing start, or already have a remote monitoring programme in place. A stepped-wedge approach design will be used, accounting for different roll-out timelines across sites.

• This evaluation requires knowledge of patients who would be eligible for CO@H prior to the initiation of the intervention, and as such can only report on those who have a positive Covid test.

• A start date of 1st October generally coincides with the Autumn acceleration of Covid incidence and provides approximately two months of pre-implementation data, the precise time at which may vary by site.

• Patients eligible for the CO@H programme prior to implementation will be defined as those who are ages 65 years or more, or those who are classified based on diagnoses held in GDPPR as being ‘clinically extremely vulnerable’.

• Evaluation will be performed nationally and the possibility to evaluate at regional and site levels will be explored based on the volume and quantity of data.

Output:

• Analysis quantifying the effect of CO@H on mortality and secondary care activity

5.3 Work package 3: Identifying Variation in Practice and Performance Between CO@H Sites

Objective 3:

To describe variation in the patient populations, routes of onboarding and patient outcomes between sites, and to use these findings to derive near- to real-time identification of outliers.

Methods used:

• This evaluation will begin by describing rates of uptake between sites over time, and examine variation in the characteristics of patients being onboarded and their routes of onboarding. The following five indicators will be the main outcomes of interest at each site. calculated for each site: A&E presentation, hospital admission, ICU admission, oxygen saturations at hospital presentation and mortality.

• In order to control for differences in the characteristics of patients cared for between sites, regression models will be constructed using data from all sites to predict local expected values of the outcome variables. Ratios of the expected to observed outcome variables will be calculated as a means of readily identifying outlying sites to enable more detailed local evaluation as needed.

• This evaluation does not incorporate information from the pre-implementation period, or from patients testing positive but not onboarded onto CO@H after implementation.

Outputs:

• Descriptive reports of overall uptake and characteristics of patient populations and outcomes nationally and for individual sites.

• Regularly updated measures of outlying site in terms of secondary care utilisation and mortality.

(RSET) Rapid Service Evaluation Team and BRACE = Birmingham, RAND and Cambridge Evaluation Centre.

As part of the RSET/BRACE evaluation, the Nuffield Trust request small numbers suppressed aggregated data on the CO@H service to be sent via the evaluation team at Imperial College. Data will be aggregated at the level of the Clinical Commissioning Group (CCG). Within this data, small number counts (<= 5) will be suppressed before transfer. The Nuffield Trust require the numbers of people onboarded onto the CO@H service each week, specifically. Numbers onboarded each week within each CCG split by:

- Tech-enabled or manual

- Age band (<65, 65-74, 75-84, 85+)

With each possible combination this will result in 8 data items within each CCG each week.

The RSET/BRACE evaluation of CO@H is a mixed-methods programme with four workstreams with the following aims:

1) Explore the effectiveness of COVID Oximetry @home (e.g. in relation to mortality and use of hospital services)

2) Identify the costs and benefits of implementing COVID Oximetry @home

3) Analyse patients’ experiences of, and engagement with the COVID Oximetry @home service

4) Analyse staff’ experiences of delivering and implementing COVID Oximetry @home

The data will be required to help answer the first of these, and, in particular the specific question as to how hospitalisations and mortality due to COVID-19 compare before, during and after implementation within each implementing area and between areas. We are sourcing data from a number of sources, for example, PHE for mortality data and HES for use of hospital data. The level of analysis will be each CCG and we will explore time series regression models to account for varying dates of implementation, the development of implementation plans over time and changing pressures on hospital services. If uptake is variable between sites, we will also investigate dose-response models during the implementation period. This approach is unique to this evaluation.

The Nuffield Trust plan for the suppressed, aggregated data to be created by the evaluation team at Imperial College, on a periodic basis, and transferred by Imperial College London through secure data transfer (SFTP) to a secure server within the Nuffield Trust. Only named individuals within the Nuffield Trust responsible for analysing data have access to this server. The Nuffield Trust has accreditation with DSPT v2 and ISO 27001.

The Nuffield Trust will only access aggregated data with small numbers suppressed - therefore are not considered a processor of NHS Digital data.

In terms of the datasets required, the following justifications apply:

General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR) will be used to determine the demographic features and clinical comorbidities of patients enrolled into the CO@H programme. Additionally, these data will be obtained for individuals not enrolled into CO@H, both before and after the start of the CO@H intervention (those who have tested positive for CV19). This will enable construction of appropriate control populations to address key evaluation questions regarding equity of access to the service and the safety of the service.

Covid-19 testing data from the Second Generation Surveillance System (SGSS) and National Pathology Exchange (NPEx) Covid-19 testing datasets will be used to identify those patients enrolled into CO@H following a positive test for Covid-19, and the time between a positive test and enrolment. Additionally, Covid-19 testing data will be used to identify those patients who had a positive Covid-19 test prior to the start of the CO@H intervention as a means of establishing a matched preintervention control population. Patient with a positive Covid-19 test after the start of the CO@H intervention will be identified in order to evaluate the equity of allocation of the intervention across all those with a positive Covid-19 test.

CO@H Onboarding data (collected from sites when a patient begins care in a CO@H programme) will be used to identify the time and routes of enrolment of patients (primary care or secondary care), in addition to the clinical acuity of patients at onboarding. These data are required to determine the duration between enrolment and presentation to hospital or mortality, and to evaluate variation in clinical acuity and routes of enrolment between sites.

CO@H Offboarding data (collected from sites after a patient leaves the CO@H programme) will be used to determine the time spent on the home oximetry programme across patient groups and between sites. It will also be used to determine whether patients used a standard or ‘tech enabled’ intervention during their CO@H programme.

Hospital Episode Statistics Admitted Patient Care (HES APC) /Critical Care (HES CC) data will be used to identify presentations to critical care departments and hospital admissions for patients enrolled into the CO@H programme, and also those within relevant control populations. Evaluating the rates of secondary care interaction are a critical aspect of the evaluation. HES data is requested from March 2017 to provide diagnosis and treatment information which may be missing from GDPPR but important to identify variation in patient populations.

Emergency Care Data Set (ECDS) data will be used to identify presentations to accident and emergency departments. Evaluating the rates of secondary care interaction are a critical aspect of the evaluation.

Civil Registration Mortality Data are required for all individuals in order to identify mortality rates in the CO@H intervention population, and also in control populations. Date of death is required to determine the time from enrolment and Covid-19 testing to death in order to conform to Public Health England definitions of Covid-19 mortality. Cause of death will allow non-Covid-19 mortality to be distinguished from deaths attributed to Covid-19.

All data will be required in pseudonymised format to enable patient-level evaluation across datasets.

Different date ranges will be used for different datasets based on their availability and role in the evaluation. GDPPR data, Civil Registration Mortality Data and Personal Demographic Service data are requested from March 2020, as marking the start of the Covid-19 pandemic in England, and will therefore be relevant to the programme. Some datasets (CO@H onboard, CO@H offboarding and Oxygen saturation levels) are only collected as part of the CO@H programme, and will not be available before October or December 2020. The date ranges for the HES and ECDS data goes back in time further. This historic data will be used to help characterise the patient population eligible for the CO@H programme by looking at previous hospital utilisation.

Data will be required for all of England in order to evaluate performance of the national implementation of CO@H.

Following discussion between the evaluation partners, NHS Digital, NHS England, and NHSX, it has been determined that there is no alternative, less intrusive way (using less information) of achieving the purpose of the evaluation.

In order to minimise the data requested, Imperial College London has only included variables needed to carry out the analysis that has been agreed by NHS England. As part of a consultation with NHS Digital and clinical and academic experts, the evaluation partners have narrowed the dataset to focus only on information that can demonstrate the clinical effectiveness of the CO@H programme.

NHS England is the sole data controller for this data sharing agreement given their role in determining the scope, and purpose of the evaluation, although all processing will be carried out by Imperial College London.

The commissioner of this work is NHS England. The role of NHS England is to provide overall project support and management. They will not carry out any of the analysis, but will ensure the delivery of the work to time and make sure evaluation partners have the tools they need to carry out the work. They have instructed the evaluation partners to carry out this work. The role of NIHR is solely to provide funding to the evaluation partners. They do not act in a data controllership capacity.

Data is stored in Secure Enclaves which is an isolated environment within the Imperial College network, physically located at a Slough datacentre operated by Virtus SDC Ltd. The servers at Virtus SDC are owned and managed by Imperial College in a dedicated area of the Virtus SDC data centre. Imperial do not have any shared racks with other organisations and operate their own switches. “Dark fibre” connections operate between Slough and the Imperial campus.

To access the Imperial servers swipe card access is needed, and live logging and alerts of that access are sent to South Kensington. CCTV covers the access to Imperial space. Dedicated 24 hour security covers the Slough datacentre. Access to the server controlled by Imperial ICT staff and heavily restricted. Virtus staff cannot enter the Imperial space without seeking permission from Imperial. Permission is granted based on the need to enter and is not “ongoing” access (with the exception of “emergency” access). Access will be recorded and investigated.

All data is stored on servers in this environment and not workstations. The Secure Enclaves is an isolated area within the Imperial College’s network. Each group has its own firewalled subnet (i.e. enclave). Systems in one enclave cannot access enclaves belonging to other groups (firewall controlled). Access into the enclaves is through a “gateway” enclave that is controlled and monitored by the Security Manager.

Servers within the enclaves and workstations accessing personal data do not have access to the internet, only trusted Imperial infrastructure devices. It does NOT include college file shares or email servers. Gateway services for the enclaves holding identifiable data only allow access from approved dedicated workstations within the college. Additionally, these dedicated workstations cannot be accessed from outside of the college. Typically, a group will have two enclaves. One for identifiable information and another for de-identified data. Dedicated gateways are used for each type of these enclaves.

The gateways allowing access to de-identified data are configured to only accept connections from specified workstations (and user accounts) within Imperial College and external specified user accounts connecting via “Pulse Secure” VPN software. The software checks for the client's OS patching and virus checking software, before allowing the connection. Pulse Secure uses ESP with 256bit strength (split tunnel).

Imperial College London expect to produce the following outputs, which are described in detail below:

Outputs to date:

• Monthly reports with interim findings prepared for the CO@h evaluation workstream

• Conference presentation on CO@h evaluation at the 2021 Health Services Research UK conference.

• Final internal briefing for key stakeholders in NHS England, NHS Digital and NHSX.

• Preprint paper - Trends and associated factors for Covid-19 hospitalisation and fatality risk in 2.3 million adults in England – Medrxiv, under review with Nature Communications

• Preprint paper - Population level impact of a pulse oximetry remote monitoring programme on mortality and healthcare utilisation in the people with covid-19 in England: a national analysis using a stepped wedge design – Medrxiv, under review with Emergency Medicine Journal

• Preprint paper - Evaluating the impact of a pulse oximetry remote monitoring programme on mortality and healthcare utilisation in patients with covid-19 assessed in Accident and Emergency departments in England: a retrospective matched cohort study - Medrxiv, under review with Emergency Medicine Journal

Anticipated output:

• Open access paper in peer review journal on equity of access to CO@h

• Open access paper in peer review journal on use of CO@h for care home residents

• Publicly available policy briefing published through the Imperial College London Institute for Global Health Innovation website

• Conference presentation on CO@h evaluation at the 2022 Health Services Research UK conference.

• Presentation to the NHSE People Receiving Social Care management team meeting -March 2022

As a result of the data processed described above, Imperial College London will share interim findings with the CO@H evaluation workstream on a monthly basis in the form of workshops (on top of regular reporting in weekly meetings). Imperial College London will prepare a briefing on the findings for circulation to key stakeholders in NHS England, NHS Digital and NHSX. All outputs will only contain aggregated data with small number suppression applied.

Imperial College London have submitted three academic papers to peer-reviewed journals have also published pre-print versions of the papers, for immediate dissemination. We will do the same for the two further planned papers.

The findings of all three proposed evaluation work packages, as well as the wider literature will be combined in a policy briefing that will be made publicly available through the Imperial College London Institute for Global Health Innovation website.

Additionally, the Imperial College London evaluation team will present findings from the evaluation at relevant conferences, not limited to, but including HSR UK. Abstracts have also been submitted for presentation at the International Society for Quality in Healthcare conference in 2022. Additional conferences will be identified in the coming months as they are announced.

Where possible the Imperial College London evaluation team will collaborate with evaluation partners in the CO@h programme, to synthesise evidence across multiple studies, and maximise impact from the work. The intent is to share the outputs of the work to the general public in the form of peer reviewed publications in open access journals in addition to reports to NHS England and other forms of dissemination.

The overall timeline of this work will be dependent on the development of the COVID-19 pandemic in England, and the duration of the CO@h programme as a result of this. The previously suggested timeline has been updated below to reflect delays in the receipt of data.

* Updated Timeline 16/03/2022 for remaining activities* :

• Policy briefing – April 2022

• Publication of papers will depend on peer review process – estimated March 2022-June 2022

• Conference presentation at HSR UK – July 2022

Sharing this data enables the evaluation of a major pathway of care for patients with Covid-19. Understanding the cost effectiveness and clinical effectiveness of the CO@H programme is critical to building safe remote monitoring pathways for Covid-19 patients in the community. Delivering effective, safe Covid-19 care is vitally important to patients and their care, as well as to NHS staff and the future of how the pandemic is managed.

In terms of measurable benefits, this work will quantifiably demonstrate the clinical effectiveness of remote oximetry for Covid-19 at a patient and CCG-level. These outcomes will drive how the NHS cares for and monitors Covid-19 patients in the community. They will also reveal any changes needed to make remote oximetry services more equitable and more effective.

The pipeline from outputs to national policy is explicit in this piece of work: the results from this evaluation will be shared regularly with NHS England specifically with those involved in the policies and standards surrounding the provision of CO@H services. Therefore, the results from this evaluation will directly inform national policy makers about how best to roll out, modify and improve home oximetry for Covid-19 patients. This pipeline from evaluation to decision making to community benefit has already been demonstrated in the pilot phase of this work, whereby an evaluation of safety of the ‘Covid Virtual Ward’ programme led to the national roll out of the CO@H programme.

The pilot work revealed a large proportion of patients using home oximetry pathways were of low clinical risk and had low rates of mortality and secondary care presentation. This finding contributed to the definition of eligibility criteria for the national rollout of CO@H. Additionally, the finding of low rates of all-cause mortality in those enrolled into home oximetry programmes through primary care indicate the overall safety of the pathway for national implementation.

The quantitative evaluation of CO@H requires understanding the clinical outcomes of patients onboarded into the CO@H programme as well as key features of their medical history. These datapoints are included in the data collection specification and directly enable an evaluation of the CO@H programme which would not be possible with any other data. Given the unprecedented need to understand how best to manage Covid-19 in the community, the data required for this evaluation will enable a statistically robust analysis which can inform and direct national policy making.

The results from this work will be made available to key stakeholders, namely NHS England, in regular reports. Furthermore, the final results will be made public with targeted publications for NHS England but also within the public academic literature, as a scientific contribution.

The evaluation will guide the ongoing implementation of the CO@H programme at national and local level. It will provide evidence as to the equity of access to the CO@H programme and the safety of the CO@H programme. These findings will be used during the implementation of the programme to support emerging evaluation concerns raised by local sites and the national delivery partners. Actions arising from the evaluation will be implemented centrally by NHS England or locally by Clinical Commissioning Groups and other care providers as required.

Findings from this analysis will benefit all patients eligible for the CO@h programme which include:

• All registered patients in England aged 65 and over

• All registered patients in England aged 18 and over who are deemed clinically extremely vulnerable in relation to COVID-19

• In particular, findings from this evaluation will serve the following purposes:

• To improve health service delivery (by evaluating policies and reporting feedback to the NHS and policy makers)

• To make health policymaking more effective (the work packages look at specific policy implementation and how this has been effective, and feedback will be given to policy makers)

These individuals will benefit through the evaluation indicating areas of inequity in provision or safety concerns in the CO@H programme thereby supporting NHS England to maintain and improve the quality of the CO@H service.

The programme may be rolled out more widely, depending on the service evaluation findings.

The outputs of the evaluation are intended to directly support the provision of the Covid Oximetry at Home programme of care by NHS England and will therefore meet the stated objective. Additional academic journal outputs will support the sharing of the findings of the evaluation with other healthcare providers nationally and internationally, and will thereby meet a secondary objective to guide future remote monitoring programmes within the NHS in England.

The yielded benefits to date are:

• Monthly reports with interim findings prepared for the CO@h evaluation workstream. These reports continued to guide the implementation of the CO@h programme over the course of the evaluation.

• Conference presentation on CO@h evaluation at the 2021 Health Services Research UK conference.

• Final internal briefing for key stakeholders in NHS England, NHS Digital and NHSX. This will inform guidance for the ongoing implementation of the CO@h programme.

• Preprint paper - Trends and associated factors for Covid-19 hospitalisation and fatality risk in 2.3 million adults in England – Medrxiv, accepted for publication by Nature Communications. This article will inform clinicians and policymakers of the importance of wider health system effects on mortality and rates of hospitalisation during peaks in Covid-19 incidence which coincided with the implementation of the CO@h programme. The findings of this study are only achievable through the unique linkage of data achieved for the evaluation and are of international importance, as reflected by the journal to which it has been accepted for publication.

• Preprint paper - Population level impact of a pulse oximetry remote monitoring programme on mortality and healthcare utilisation in the people with covid-19 in England: a national analysis using a stepped wedge design – Medrxiv, accepted for publication by the Emergency Medicine Journal. This article will publicly report the evaluation of a major national clinical programme. It will additionally provide a framework for the future evaluation of similar pathways in the UK and elsewhere.

• Preprint paper - Evaluating the impact of a pulse oximetry remote monitoring programme on mortality and healthcare utilisation in patients with covid-19 assessed in Accident and Emergency departments in England: a retrospective matched cohort study - Medrxiv, under review with Emergency Medicine Journal. This article will influence future guidance for the implementation of the CO@h programme in clinical settings, particularly for those who have recently attended A&E departments.

Generally, the evaluation has found the service was largely delivered equitably. Some areas of concern have been identified and have been shared with NHS England in a series of meetings and presentations. Additionally the findings of this component of the evaluation are currently undergoing journal submission.