The SIPS study

Pressure ulcers are a serious problem for patients and their carers. They range in severity from red skin (Stage 1) to deep wounds through muscle to bone (Stage 4). Pressure ulcers have a major impact on quality of life; they may heal slowly and become infected and can increase the risk of dying in older people. They are also a costly problem for the National Health Service (NHS). People with pressure ulcers are usually treated in the community but may need hospital care. Common treatments for pressure ulcers include pressure relief, dressings and encouraging movement and change of position. Surgery can be used to try and close deep pressure ulcers but in the United Kingdom (UK) this treatment is not common. Finding out whether surgery works as a treatment is very important to people affected by pressure ulcers. Currently, it is not clear which patients with pressure ulcers may benefit from an operation and which of the different ways of doing the surgery seems best. NICE guidance on pressure ulcers makes no recommendations about surgical management in relation to reconstruction (although there is guidance on debriding which is not the focus of this study).

The University of Bristol and University of Manchester are joint data controllers for the SIPS (Surgical interventions to treat severe pressure sores) study, which aims to find out more about how best to conduct research in this area by undertaking three workstreams, these can be summarised as:

(i) literature reviews and interviews with healthcare professionals

(ii) retrospective cohort studies

(iii) formal consensus methods with healthcare professionals and patients.

The Data provided under a previous iteration of this agreement is used for workstream ii - retrospective cohort studies.

The study analyses Data collected routinely in the NHS over a period of 8 years. The study will describe the care that has been provided in England to patients with severe pressure ulcers, the kinds of patients who have been treated in different ways and examine how care is different in different places. To inform whether surgical treatments should be more widely available, the study will identify patients who were similar when admitted to hospital with a severe pressure ulcer and compare health outcomes (such as going back to hospital and death) among those who did and did not have surgery.

NHS England Data provided under the previous iteration of this agreement is used alongside data from Clinical Practice Research Datalink (CPRD) GOLD. CPRD GOLD provides Primary Care data collated from General Practitioners across the UK. This data provides a valuable insight to Primary care provisions for patients with pressure sores in addition to the Hospital Episode Statistics and mortality data provided by NHS England.

The CPRD GOLD data will not be linked with NHS England data in any way. CPRD GOLD data is fully anonymised and therefore the study team would have no way to link this data with the pseudonymised HES Data.

The study team had undertaken preliminary work to determine which clinical codes are used to identify an admission with a severe pressure ulcer. Under the previous iteration of this agreement, NHS England established a cohort of patients who had received hospital care for pressure sores using the clinical codes. The cohort includes adult patients in England for the period 01/04/2011 to 31/03/2019 with an index admission with one or more ICD-10 codes relating to full skin thickness pressure ulcers - codes L89.2, L89.3 and L89.9 (used after 01/04/2012) and prior to this date code L89.X. These codes were selected to ensure that the study team only requested data relevant for analysis within the study.

These index admissions were identified from the HES APC data set. The study then requested that these identified patients (the “cohort”) are linked to all HES APC and HES OP data, and Civil Registration (deaths) data for the period 01/04/2011 to 31/03/2019.

Only pseudonymised data is requested. This record level data allowed the study team to understand pathways taken by patients with severe pressure ulcers through the hospital system, including pathways which end in patient death. Data for all of England was required as the number of surgical reconstructions undertaken for severe pressure ulcers in England is very small, and a large geographical spread enabled the study to pick up as many reconstructions as possible. This also justified the number of years of data requested, coupled with the expectation that patients with pressure ulcers are generally unwell and are anticipated to have numerous episodes of contact with healthcare providers. The data provided under the previous iteration of this agreement was only that required to describe the patients with a diagnosis of severe pressure ulcer on hospital admission, their care pathways after admission and frequencies of health outcomes.

University of Bristol - who are the host organisation for the Chief Investigator and Clinical Trials Unit (CTU) - determine ‘why’ and ‘how’ the personal data under this agreement will be processed. University of Manchester host the co-Chief Investigator for the study and are responsible for making decisions regarding how the data are processed. For this reason, University of Bristol and University of Manchester will be Data Controllers for the purpose of this agreement.

Only University of Bristol will process data under this agreement. The Clinical Trials Unit (CTU) for this study is the Bristol Trials Centre, (formerly Clinical Trials and Evaluation Unit), this CTU is part of the University of Bristol. All processing activities will be undertaken on University of Bristol computers.

Processing of the Data is undertaken by substantive employees from the University of Bristol only. As such, University of Bristol is the only organisation which processes personal data on behalf of the Data Controllers.

Other named study collaborators on the collaboration agreement will not have a role as either data controller or data processor - their role in the study is as co-applicant and these organisations are represented on the study management group. University Hospitals Bristol NHS Foundation Trust, Manchester Hospitals NHS Foundation trust, University of Leeds and University of Oxford will have no control or influence over the data under this Agreement and will have no access to any data. These organisations were involved in the design of the study but will not be involved in data processing or directly determining how personal data should be processed. University Hospitals Bristol NHS Foundation Trust have an additional role in the study as they hold the funds for the study and will be the organisation invoiced for this application.

The SIPS study has been funded by the NIHR under the NIHR Health Technology Assessment award, which commenced in November 2019. The funder does not make any decisions regarding the data requested under this agreement.

Data is being processed under Article 6(1)(e) and Article 9(2)(j) as a task in the public interest, as part of an NIHR funded ethically approved clinical trial. All data is pseudonymised.

The alternative to using routine data sources would be to undertake a prospective study of patients with severe pressure ulcers undergoing reconstructive surgery. However, it would be challenging to recruit a sizeable cohort and results would take many years. A retrospective study will allow analysis of a large sample and for the study aims to be addressed more quickly and cost-effectively.

This study does not require any flow of data to NHS England. NHS England created a cohort using index admissions and then linked to HES APC, OP and mortality data. The cohort created by NHS England was linked to HES APC and OP data for the preceding 12 months and to HES APC, OP and mortality data from the point of index admission to 31/03/2019. This pseudonymised linked cohort flowed from NHS England to the study team at the University of Bristol. There will be no further flow of data. The linked cohort includes personal data, including health data. However, all outputs will be pseudonymised. Only the University of Bristol will process the data under this agreement.

The data provided by NHS England will be processed at the University of Bristol in order to;

- describe the patients with a diagnosis of severe pressure ulcer on hospital admission,

- describe their care pathways after admission and

- determine the frequencies of health outcomes including death.

Processing will also take place in order to compare health outcomes in matched groups of patients who were similar on admission and who did/did not have a surgical reconstruction operation. This will include a comparison of mortality rates.

METHOD

1) NHS England created a cohort by identifying participants which meet the criteria provided by the study (relevant ICD-10 codes)

2) NHS England linked the cohort to HES Outpatients, HES Admitted Patient Care and Civil Registrations (Deaths) data for the period April 1st 2011 - March 31st 2019

3) Within this period, only data 12 months prior to a participant's index admission date and subsequent data up until March 31st 2019 was provided.

At no point will identifiable information be provided to NHS England by the University of Bristol, or by NHS England to the University of Bristol.

DATA MINIMISATION

The data sets, episodes and fields provided are those required to complete analyses for this NIHR funded study. Mortality data is required for completeness of patient pathways. Only relevant data fields for the study have been chosen (for example, no items from the sections on Maternity, Neo-natal Mortality, or Psychiatric)

- The study requires data for the specific time period between April 1st 2011 - March 31st 2019, however, only data 12 months prior to a participant's index admission date and subsequent data up until March 31st 2019 is requested and will be provided by NHS England.

- only those patients 18 years and over

- only those patients treated in hospitals in England.

- Only those patients with the ICD-10 codes: L89.2, L89.3 and L89.9 (used after 01/04/2012) and prior to this date code L89.X for any full skin thickness pressure ulcer.

All data is pseudonymised and no attempt will be made to re-identify patients. The data received by the University of Bristol will not be used for any purpose other than to meet objectives as stated in this Data Sharing Agreement and will not be shared with any other third party or organisation.

In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, you must make sure that:

· cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table.

· Zeros (0) do not need to be suppressed.

· All other counts will be rounded to the nearest 5.

Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Processing of the Data is undertaken by substantive employees from the University of Bristol only. HES and mortality data is stored on University of Bristol managed servers and will only be accessible by authorised users with system access permissions.

Data will not be accessed remotely. Data will be downloaded directly from NHS England's Secure Electronic File Transfer (SEFT) service to a University of Bristol Safe-Haven folder. Access to this folder is restricted to specific users, with access logs kept for 12 months and data encrypted at rest on the server.

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). Mortality data Terms and Conditions will be adhered to.

The study team will report findings at conferences and in high-impact, peer-reviewed journals, such as The Lancet or British Medical Journal (BMJ). The study team will also produce a final report for the funder (NIHR) in 2023. Outputs will report aggregate data with small numbers suppressed, as per NHS England's HES Analysis Guide.

Findings will be reported to NHS England’s National Wound Care Strategy, which will provide a key avenue to communicate findings. The findings will have an impact on clinical practice through engagement with professional bodies; the study team have strong links with relevant organisations including the Tissue Viability Society and NICE.

The study team will draft media-friendly articles for relevant trade journals such as the Nursing Times and Nursing Standard. They will summarise the work using widely-accessed, research-focused resources such as The Conversation and Kudos. The study team will also contact the NIHR Dissemination Centre to ask for advice where there are specific findings they wish to publicise. Publications will be supported by targeted social media activity, especially through Twitter, using a study specific account as well as currently running accounts that link to a wide range of relevant stakeholder groups to ensure widespread dissemination. Where required, press releases and media support will be provided.

With respect to dissemination of findings to patients and their carers, The SIPS study team will ensure members of the Patient and Public Involvement forum are actively involved in carrying out activities relating to dissemination and public engagement. Opportunities such as talks to local groups and other events will be considered on a case by case basis.

A lay summary of the research and its findings will be written and added to the University of Bristol websites and relevant blogs. The study team also have close links with local Trusts and will aim to distribute the lay summary locally at relevant patient events in addition to online content. To support further engagement work, the study team will liaise with experienced colleagues at the NIHR Manchester Biomedical Research Centre and Public Programmes at Manchester University NHS Foundation Trust to undertake a range of engagement activities at public events including the Manchester Science Festival. These activities will raise the profile of pressure ulcers and research to improve their management. The study team will link with existing networks at the University of Manchester to ensure their findings are presented locally to both academics, clinicians and members of the public, for example the Manchester Institute for Collaborative Research on Ageing, seminars for which are regularly well attended by each of these groups.

Patient and public involvement will be encompassed in all steps of the study.

Dissemination to participants is not relevant for this study, as there is no active patient involvement.

The data will be used to undertake a retrospective cohort study to collect information on care pathways for patients with severe pressure ulcers, and to compare patient outcomes in patient who do/do not have reconstructive surgery.

There is a dearth of research in this field, and this will be a valuable source of information relating to the treatment of severe pressure ulcers. This study is part of a wide project which aims to provide a package of research to enable the design of a randomised controlled trial of reconstructive surgery for severe pressure ulcers. Surgical reconstruction of pressure ulcers is rarely carried out in the UK and the impact of major surgery on people with severe ulcers has not been investigated in detail. There is also very limited information about how surgical reconstruction impacts on health-related quality of life. This is an important area of research as severe pressure ulcers have a significant chronicity and cause serious problems for patients, their carers and the NHS. The research is also important because of uncertainty about the patients in whom reconstructive surgery to repair a pressure ulcer is effective in the short, medium and long-term, and the surgical techniques that should be used. Preliminary analyses showed that, over a 2-year period, over 81,000 patients in England had an index hospital admission for a severe pressure ulcer.

The study funder - the NIHR - originally asked for a randomised controlled trial of surgical management of severe pressure ulcers. However, the study team found that there was no sufficient data to be able to define the populations, interventions and comparators of interest. The aim of the SIPS study is to describe and define those parameters, and through consensus meetings provide guidance on the parameters of most importance to patients and healthcare professionals. The outputs of this study will be used to inform a consensus process of healthcare professionals and patients, which will ultimately lead to the creation of a series of recommendations about which treatments are appropriate for whom and when. These recommendations will be published by the study team at the University of Bristol and other study co-applicants, and will act as the basis for the design of a randomised controlled trial. The consensus process is one of the study workstreams and a key output. The Study's Personal and Public Involvement (PPI) co-applicant is working to bring together a group of patient representatives and the study team are also in contact with various patient organisations. Surgeons and nurses who complete the study surveys will be invited to leave their contact information if they are interested to participate in the consensus meeting.

The results of the SIPS study will be written up in 2023, and it is anticipated by the study team that this evidence would inform policy makers shortly after this. The aim is for the results to inform the design of a randomised controlled trial, which would be undertaken in the following years.

This study is not related to a PhD/post graduate research study.

The SIPS Study final report is still being drafted and this renewed DSA request is to allow further time for the data to be analysed to that end, and for publication purposes.

Outputs to date:

The study has so far had an abstract accepted and presented a poster at the International Clinical Trials Methodology Conference 2022 entitled, 'Challenges of emulating a target trial for surgical management of full-skin thickness pressure ulcers using routine data'.

Our Co-CI, Jo Dumville et al presented 'The contribution of thematic analysis of free text survey data to the quantitative analysis of two clinician surveys of surgical interventions for severe pressure ulcers (PU) ' at the Society for Social Medicine 2022.

Jo Dumville also presented 'How do we define future comparative evaluation of reconstructive surgery for severe pressure ulcers?' to Wounds Research Network Conference 2022, Glasgow.

Barney Reeves, study Co-CI presented 'Effectiveness of surgical reconstruction to treat full-skin thickness pressure ulcers: evidence and feasibility of research' to Society of Tissue Viability, Peterborough, at the Kingsgate Conference Centre, 26 – 27 April 2023.