MR1477 - EPIdemiology of Critical Care After Surgery (EPICCS)
Royal College of Anaesthetists · Academic
In term In term in the September 2026 edition: the latest version runs to 23 November 2026.
- Reference
- DARS-NIC-88623-F2H1Q
- Current version
- v2.9
- Term of current version
- 24 November 2023 to 23 November 2026
- Start date
- 10 January 2019
- Data controller
- Joint Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 6
Data controllers
Why the data was released
Objective for processing
The Sprint National Anaesthesia Projects (SNAPs) are 'snapshot' evaluation studies of clinical activity and patient-centred outcomes that are important and relevant to both patients and anaesthetists.
The 2nd Sprint National Anaesthesia Project: Epidemiology of Critical Care provision after Surgery (SNAP-2: EpiCCS) will describe the epidemiology of perioperative risk and outcome, and critical care referral and admission after inpatient surgery in the UK. It also aims to examine whether planned postoperative critical care admission is effective as an intervention to reduce postoperative morbidity.
After surgery, complications can sometimes occur, including mild ones like nausea, and more major ones such as infections, and very rarely death. One way which may help to prevent complications in some patients is to admit patients to a Critical Care Unit (CCU) after their operation, where they can receive more intensive nursing support, or treatments not available on other hospital wards. Critical care would normally only be considered for people who are having either a very big operation, or who have several significant background illnesses. Previous research studies have shown that the proportion of patients admitted to CCU after surgery differs between hospitals and countries. The study has been conducted to try and uncover some of the reasons for these findings, and to see if Critical Care admission after surgery improves patient recovery after surgery.
The overall aim of the study is to help improve care for people undergoing surgery.
The purpose of the proposed data linkage is to enable The Royal College of Anaesthetists (RCoA) to answer research questions about the associations between postoperative morbidity, postoperative admission to a critical care unit, and longer-term outcomes for patients undergoing major (inpatient) surgery.
Background:
The admission of high-risk patients to critical care after surgery is a recommended standard of care. Nevertheless, poor compliance against this recommendation has been repeatedly demonstrated in large epidemiological studies. It is unclear whether this is due to reasons of capacity, equipoise, poor quality clinical care or because hospitals are working creatively to create capacity for augmented care on normal surgical wards. Importantly, the clinical effectiveness of critical care as an ‘intervention’ is uncertain, and the threshold for admission to critical care (i.e. the risk profile of patients who might benefit) is currently based on expert opinion rather than research.
The EPIdemiology of Critical Care after Surgery (EPICCS) study aims to address these uncertainties. The study is a one-week observational cohort study including all patients who underwent inpatient (overnight stay) surgery between March 21st - 27th 2017. All patients had prospective data collection on risk factors, surgical procedure and postoperative outcomes including the primary outcome of morbidity (measured using the Postoperative Morbidity Survey on day 7 after surgery) and secondary outcomes including length of stay and inpatient mortality. The epidemiology of patient characteristics, processes and outcomes will be described once analysis is conducted. Inferential techniques (multilevel multivariable regression, propensity score matching and instrumental variable analysis) will be used to evaluate the relationship between critical care admission and postoperative outcome.
The protocol for the study has been published in the British Medical Journal: (Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 1;7(9):e017690.)
University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH) Joint Research Office helps to administer research to both partner organisations. The Royal College of Anaesthetists (RCoA) and UCL are the data controller for this study, as joint decisions on how to use the data rest with the RCoA and the Chief Investigator of the Project - substantively employed by University College London.
EPICCS is being jointly led (in terms of determining the study and how the analysis will be conducted) by staff at UCL and the National Institute of Academic Anaesthesia’s Health Services Research Centre (NIAA-HSRC) - who for this project are based at the RCoA. The NIAA was established in March 2008. Its vision, with respect to anaesthesia and related specialties, is to improve patient care by promoting the translation of research findings into clinical practice; develop and maximise its academic profile within the healthcare profession, NHS, universities and major research bodies; facilitate high profile, influential research; facilitate and support training and continuing professional education in academia. It is based at the RCoA (who are joint data controller and processor) , and UCL/UCLH Joint Research Office but with no role in determining how the data will be used or processed - that's decided by UCL and RCoA and funded by the Royal College of Anaesthetists, the UCL Surgical Outcomes Research Centre and the National Institute for Academic Anaesthesia.
The study has been funded by these organisations based on scientific merit and potential to improve patient outcomes.
Aim:
1. To describe the epidemiology of critical care admission after surgery
2. To determine the clinical effectiveness of planned critical care admission after surgery
Research Questions pertinent to this application
1. Do previously validated risk stratification tools accurately predict postoperative mortality?
2. Does immediate critical care admission reduce postoperative morbidity and mortality?
3. Does short-term morbidity independently predict longer term mortality and other adverse outcomes (e.g. hospital readmission)?
Lawful Basis for Processing:
Royal College of Anaesthetists are processing the data in line with their charitable goals as part of their legitimate interests. This is covered under the UK General Data Protection Regulation Article (GDPR) 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment that The Royal College of Anaesthetists have undertaken - the data requested is to help achieve the following: "Scientific and Statistical Research - particularly in regards to anaesthesia, as the college is the professional representative body . Anaesthetists, have overall responsibility for patients' well-being before, during and after surgery, and research such as EPICCS is integral to monitor and investigate this.
The data is also required for service evaluation purposes - meeting the conditions outlined as per Article 9 (2)(I) of the UK GDPR. Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy. The Royal College of Anaesthetists are carrying out service evaluation work as described in this agreement to To determine the clinical effectiveness of planned critical care admission after surgery.
UCL: The linkage requested is necessary for the overall objective of the study and also for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller - 'helping improve care for people undergoing surgery. This is in line with Article 6 (1)(E) of the UK General Data Protection Regulation. UCL as a research university (public authority) can rely on this legal basis.
The data is required for research purposes - meeting the conditions outlined as per Article 9 (2)(J) of the UK GDPR where 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. University College London (UCL) are carrying out research work as described in this agreement to investigate and answer various research questions into describing the epidemiology of critical care admission after surgery and clinical effectiveness of planned critical care admission after surgery.
STUDY DESIGN
EpiCCS is a one-week, prospective observational cohort study of patients and anaesthetists in NHS hospitals. It incorporates the following:
Data will be collected by perioperative anaesthetists on all patients undergoing inpatient surgery in participating UK hospitals for one week. Postoperative morbidity will be recorded for patients who remain in hospital on Day 7 after surgery. Mortality data will be collected through linkage with Hospital Episode Statistics data facilitated by NHS England (formerly NHS Digital). The dataset will also include patient risk factors, and questions about clinical decision-making and resource availability related to critical care referral and admission. The main EPICCS patient study will include all patients undergoing inpatient surgery (elective or emergency) during the study week.
Additionally, an organisational questionnaire for each hospital will be completed to describe structure and process in those institutions, the number and reasons for any cancellations of surgery during the study, and critical care unit occupancy at regular time-intervals throughout the one-week data collection period. The epidemiology of perioperative risk stratification, postoperative care and patient outcome will be described. Multivariable regression, instrumental variable and propensity score matched analyses will be conducted to ascertain the clinical effectiveness of postoperative critical care admission in reducing adverse outcomes after inpatient surgery.
A survey of anaesthetists and surgeons on their attitudes and behaviours regarding risk prediction and postoperative critical care admission. All anaesthetists and surgeons who undertake perioperative care for inpatient surgery during the study period will be invited to participate.
At the time of data-entry onto the EpiCCS webtool, confidential patient information will be retained and stored securely in their original format within the database, however different database access privileges (dependent on usernames and passwords) will apply to different users of the database:
• Local investigators within NHS Trusts will have access to their own full datasets, including patient identifiable information.
• The central EpiCCS study team will only have access to an anonymised dataset for analysis. Among the patient identifiers, only sex will be used for analysis. In this dataset the NHS number will be replaced by a unique study patient identifier; Date of Birth will be converted to Age on date of surgery, and trimmed to month and year of birth; Postcode will be converted to PCT, SHA of residence, and the Office for National Statistics Lower Super Output Area, which allows the allocation of the Index of Multiple Deprivation.
• The Royal College of Anaesthetists (Deputy Chief Executive Officer) will extract the required patient identifiable data from the study database onto a password protected Excel spreadsheet, and email this securely to NHS England to perform data linkage. NHS England will return to the Royal College of Anaesthetists a file containing the HES and MRIS data and a study id. The NHS England data will be linked to the EPICCS data and a pseudonymised dataset will be accessed by UCL and RCoA for analysis.
EPICCS was a one-week, prospective observational cohort study of patients undergoing inpatient surgery in participating hospitals. The study recruited 22,993 patients for one week in March 2017 (patient recruitment phase), in a total of 245 NHS Hospitals throughout the UK with a planned follow-up of 10 years (to track longer-term survival). Recruitment has now therefore finished.
Eligibility criteria
All UK NHS hospitals which undertake inpatient surgery were eligible to take part. All UK hospitals are eligible but it is only those hospitals with patients in critical care during the one week outlined in the application that participate in the study.
Inclusion criteria:
Adult (>=18 years) patients undergoing surgery or other interventions who were expected to require overnight stay in hospital which require the support of an anaesthetist. These would include all procedures taking place in an operating theatre, radiology suite, endoscopy suite or catheter laboratory for which inpatient (overnight) stay is planned, including both planned and emergency/urgent surgery of all types, Caesarean section, surgery for complications of childbirth, endoscopy and interventional radiology procedures.
Exclusion criteria:
Patients who indicated they do not want to participate in the study; Ambulatory surgery; children (<18 years); non-surgical obstetrics; ASA-PS grade VI; non-interventional diagnostic imaging (e.g. CT or MRI scanning without interventions); emergency department or critical care interventions requiring anaesthesia or sedation but no interventional procedure
The purpose of patient-level data linkage is to:
- be able to track longer term mortality via the MRIS (Medical Research Information Service) mortality tracking system;
- to report hospital readmission (rates and reasons) through linkage with HES data.
HES APC and CC data are required to determine rates and reasons for readmission to hospital after the initial discharge following surgery. Hospital readmission is a complication of surgery which should be included in any outcome analysis.
Full date of death from patients in the cohort is required to track patient outcomes and for survival analysis modelling (which requires accurate time to death following surgery duration to perform). This came from the MRIS data.
The RCoA also requested an extract of tabulated data. This purpose of this was to obtain total number of surgical procedures carried out in England during the study period in hospitals participating in the 2nd Sprint National Anaesthesia Project: EPIdemiology of Critical Care provision after Surgery - during 21st March 2017 and 27th March 2017. The number of procedures for each procedure code should be tallied for each hospital. These data will then be compared against the total number of cases recruited to the SNAP-2: EPICCS study in order to identify how accurate the sampling strategy has been in capturing data on a representative number of surgical operations being conducted across England. This was provided under a separate agreement issued by NHS England.
Data will also be accessed by:
PhD students whom will also hold Honorary Contracts with either RCoA or UCL. The individuals have completed mandatory data protection and confidentiality training and is subject to RCoA orUCLs policies on data protection and confidentiality. The individuals accessing the data will do so under the supervision of a substantive employee of RCoA or UCL. RCoA orUCL would be responsible and liable for any work carried out by the individuals. The PhD students would only work on the data for the purposes described in this Data Sharing Agreement (DSA).
The PhD work will form part of the wider study and their work will concentrate on a small section of the study. These are the study questions that will directly relate to the PhD thesis:
1. How do clinicians determine the risk of postoperative mortality in clinical practice?
2. Do previously validated risk stratification tools accurately predict postoperative mortality?
3. On what basis do clinicians refer patients for planned postoperative critical care?
4. What factors influence whether patients receive planned postoperative critical care?
SNAP-2: EpiCCS has had patient and public involvement from inception of this study. This includes an individual patient representative, who has had several major surgical procedures and has also been a patient representative on a previous NIHR funded study sponsored by UCLH. This individual has commented on the study design, was a co-applicant on the grant, is a member of the study steering committee and has provided input to all aspects of the study including dissemination. The study has had further review of the patient information sheets by another individual, representing the Royal College of Anaesthetists’ Lay Representation Committee.
RCoA has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group, both of which have significant patient and public involvement, and will advise on how best to communicate the findings in language understandable by to the public
Processing activities
Patient level data
Data from patients undergoing surgery in the UK between 21 - 27 March 2017 were collected and entered onto a secure online database (EPICCS IT system) controlled by the Royal College of Anaesthetists. The EPICCS IT system is stored on ANS Group Limited (previously known as UKFast) servers. This data included patient identifiable information, however data exports used by researchers from this database are pseudonymised on export. Patient identifiable information is only accessible by the Data Controller for the study at the Royal College of Anaesthetists (Deputy Chief Executive Officer). Patient identifiers were extracted from the database, which contained the following identifiers in order to perform linkage with HES and MRIS (Mortality) Products from NHS England:
- EPICCS Study identifier
- NHS number
- Date of Birth
- Sex
- Postcode
RCoA previously sent the extract of patient identifiers to NHS England securely. For each patient in the list, NHS England identified the matching HES episodes and the Mortality data from the MRIS products. NHS England then returned to the Royal College of Anaesthetists a file containing only the requested data and the EPICCS identifier (Study ID).
This file with NHS England linked data was placed in the secure RCoA server accessible only to the project data manager, a substantive employee of RCoA, and did not contain NHS number, postcode or date of birth. The dataset was analysed by the RCoA to produce results for EPICCS reports and other EPICCS outputs, but was not and will not be relinked or used in conjunction with any other data to re-identify patients or to perform any other analysis outside of this study. No data will flow under v2 of this agreement.
The data returned from NHS England was linked to the EPICCS data. The pseudonymised dataset has been and will be accessed by UCL and RCoA for analysis only. The applicants require an extension (as per v1 of this agreement) to continue the data analysis.
Data will be accessed by individuals with an honorary contract with either RCoA or UCL. The individual(s) will act as an agent of RCoA or UCL at all times under supervision from employees of RCoA or UCL. Aside from this/these individuals, access is restricted to employees or agents of RCoA or UCL who have authorisation from the Principal Investigator.
Data storage
The study will use ANS Group Limited to store data. The server is hosted by ANS Group Limited in a secure datacentre. All traffic passes through Cisco equipment including Anomaly Detection Systems (ADS), Intrusion Detection Systems (IDS) and Intrusion Prevention Systems (IPS). This is clustered across multiple locations. The hardware is protected by a Cisco Firewall with full access controls enabled. ANS Group Limited will carry out annual security audits. These audits will inspect the system for any vulnerabilities or threats that could allow hackers to destroy or damage the system. Each ANS Group Limited datacentre is fully powered, secure, resilient and equipped to meet the project demands. The company has a track record in delivering to many private and public sector clients including the NHS and has demonstrated a strong awareness of the need to protect systems and data from both physical and virtual threats. ANS Group Limited has attained ISO-27001:2013 certification for their Information Security Management System and ISO 9001:2008 for their Quality Management System. They are Payment Card Industry Data Security Standard (PCI) compliant for all client transactions.
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.
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 England/Wales. The data will not leave England/Wales at any time.
UCL and RCoA have overall responsibility for the research and the outcomes of the study and are joint data controllers.
Expected output
The expected outputs of the processing will be:
• A report of findings to the organisations who have provided grant funding which includes: NIAA and (Association of Anaesthetists of Great Britain and Ireland Project Grant), the RCoA and the UCLH/NIHR Biomedical Research Centre (UCL Surgical Outcomes Research Centre). Other stakeholder organisations have been involved in study planning, including the Faculty of Intensive Care Medicine and Intensive Care Society will also receive the report. The report of findings will be conducted 5 years, and then 10 years after the first data linkage (which was in 2018). Therefore, the study will rely on ongoing NHS England Data linkage to the end of 10 years. This follow-up will be subject to an amended and approved agreement from NHS England.
• Submissions to peer reviewed journals via several research manuscripts that will be open access. Three manuscripts have already been published (two in 2018 and one in 2020) however none of them involved the use of linked NHS England data. Authorship of future manuscripts will be determined by the Chief Investigator, with the agreement of the Project Team (UCL and RCoA members), and comply with International Committee of Medical Journal Editors (ICJME) standards. The submission and frequency of future manuscripts being published, is contingent on the findings of the study.
• Further presentations at national/international meetings. Presentations so far include:
-SG ANZICS (Asia Pacific Intensive Care Forum) (May 2018)
-EBPOM (Evidence Based Peri-Operative Medicine) Conference (July 2018)
-Intensive Care Society - State of the Art (December 2018)
-Royal College of Anaesthetists – 2 conferences so far
• Publication of any results and reports on RCoA’s website.
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 relevant recipients through the following dissemination channels:
• Journals
• Webinars open to participants, including those who work within the Anaesthetists field and for anyone else who has an interest in the topic.
• Social media
• Live-action & animated video content on an open-access YouTube channel
• Public reports: Outcomes of the study will be disseminated by the RCoA, which has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group. They will advise on how best to communicate the findings in language understandable by the public.
• Press/media engagement: Already received lay media coverage from BBC News in September 2018 (https://www.bbc.co.uk/news/health-45432538). Similar coverage is expected in future outputs due to the topical nature of the questions being asked surrounding the relationship between ethnicity, deprivation and outcome, including long-term outcome and resource utilisations.
• Face to Face Presentations.
• Public promotion of the research will be achieved using the resources of the RCoA and other stakeholder Royal Colleges and the NIAA-HSRC, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public.
Expected measurable benefits
The EPICCS study will evaluate research questions related both to policy and clinical practice.
Policy:
- Is there a sufficient numbers of critical care beds to meet the demand from surgery and to provide a high quality service?
- Are surgical patients in hospitals where there is increased demand for critical care beds disadvantaged?
Clinical practice:
- Do current methods of risk prediction accurately predict short and longer term outcome after surgery?
- Is critical care an effective intervention to prevent postoperative complications?
Answering these questions will provide opportunity to substantially improve quality of perioperative care and the understanding of the factors which influence patient outcomes after major surgery.
Publishing in peer-reviewed journals could result in
• A greater discussion of the strengths and weaknesses of the results
• Provide the benefit of peer-review of the work from third parties.
• Reports produced as a result of the study may contribute to clinical guidance and national policy. In particular the relevant stakeholder organisations involved in study planning will receive reports of the findings which could directly influence policy recommendations and guidelines issued by them which the Department of Health and NHS England look to for future workforce and infrastructure planning.
Outputs will be looked upon keenly by healthcare professionals closely involved in patient care at the coalface because of the following:
• The RCoA is a member of the Academy of Medical Royal Colleges, and therefore provides expert guidance to the Department of Health and other NHS bodies on strategic matters concerning perioperative medicine, surgery and anaesthesia.
• The Chief Investigator for this study is the associate national clinical director for elective care at NHS England, and therefore has high-level access to key decision makers within the NHS in England.
• The study has benefitted from collaboration with over 2,800 anaesthetists, surgeons and research professionals in NHS Trusts throughout the UK, who are all directly invested in the study’s results.
Benefits reported so far
Study intended aims:
1. To describe the epidemiology of critical care admission after surgery
2. To determine the clinical effectiveness of planned critical care admission after surgery
Research Questions (RQ)
1. How do clinicians determine the risk of postoperative mortality in clinical practice?
2. Do previously validated risk stratification tools accurately predict postoperative mortality?
3. On what basis do clinicians refer patients for planned postoperative critical care?
4. What factors influence whether patients actually receive planned postoperative critical care?
5. Does immediate critical care admission reduce postoperative morbidity and mortality?
6. Does short-term morbidity independently predict longer term mortality?
A primary analysis (Aim 1) of the epidemiology of critical care admission has been completed, factors which influence clinician referral to critical care (RQ3 and 4), capacity and needs assessment for critical care after inpatient surgery (RQ4), and accuracy of clinician perioperative risk prediction (RQ1 and 2). This body of work has been submitted as a PhD thesis and was due to be defended later this year, before the COVID-19 Pandemic was declared. This body of work has now been released https://discovery.ucl.ac.uk/id/eprint/10108589/.
The work has also influenced policy on a national scale in the UK with regards to critical care provision in enhance care wards (due to be published by the Faculty of Intensive Care Medicine and Royal College of Physicians, London).
The 2018 cancellations paper influenced national policy, shown by the development of elective hubs and the development of enhanced perioperative care services, both of which are now national policy. It has also influenced the way in which NHS England now collects data on rates and reasons for cancellation of surgery.
The paper published in PLOS Medicine evaluated the performance of the Surgical Outcome Risk Tool (SORT) for predicting 30-day mortality after surgery. It is cited in national guidelines on preoperative assessment and the findings have been incorporated into a systematic review which identified the Surgical outcome risk tool (SORTsurgery.com) as the best risk model for preoperative prediction of 30day mortality after surgery worldwide (Anaesthesia Journal 2023)
The secondary analysis looking at the effectiveness of critical care on outcomes (Aim 2, RQ 5 and 6) is due to begin imminently.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Identifiable | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Critical Care (HES Critical Care) | Identifiable | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| MRIS - Cause of Death Report | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| MRIS - Flagging Current Status Report | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were applied to all 6 files released under this agreement, across every version. About opt-outs
No files recorded as released under the current version. 6 were released under earlier versions, shown in the version history.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-88623-F2H1Q-v2.9 24 November 2023 to 23 November 2026
- Title
- MR1477 - EPIdemiology of Critical Care After Surgery (EPICCS)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); MRIS - Cause of Death Report; MRIS - Flagging Current Status Report
What changed from DARS-NIC-88623-F2H1Q-v1.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2023-11-24 | |
| End date | 2026-11-23 | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): type of data | Identifiable | |
| Hospital Episode Statistics Critical Care (HES Critical Care): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Hospital Episode Statistics Critical Care (HES Critical Care): type of data | Identifiable | |
| MRIS - Cause of Death Report: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| MRIS - Cause of Death Report: type of data | Identifiable | |
| MRIS - Flagging Current Status Report: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| MRIS - Flagging Current Status Report: type of data | Identifiable |
Objective for processing
[4 paragraphs unchanged]
The purpose of the proposed data linkage is to enable The Royal College of
Anaesthetsists
Anaesthetists
(RCoA) to answer research questions about the associations between postoperative morbidity, postoperative admission to a critical care unit, and longer-term outcomes for patients undergoing major (inpatient) surgery.
[4 paragraphs unchanged]
University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH) Joint Research Office helps to administer research to both partner organisations. The Royal College of
Anaesthetsists
Anaesthetists
(RCoA) and UCL are the data controller for this study, as joint
[13 words unchanged]
Chief Investigator of the Project - substantively employed by University College London.
EPICCS is being jointly led (in terms of determining the study and
[129 words unchanged]
decided by UCL and RCoA and funded by the Royal College of
Anaesthestists,
Anaesthetists,
the UCL Surgical Outcomes Research Centre and the National Institute for Academic Anaesthesia.
[9 paragraphs unchanged]
Royal College of Anaesthetists are processing the data in line with their charitable goals as part of their legitimate interests. This is covered under the
UK
General Data Protection Regulation Article
(GDPR)
6(1)(f) - This work is necessary for the purposes of the legitimate
[100 words unchanged]
and research such as EPICCS is integral to monitor and investigate this.
The data is also required for service evaluation purposes - meeting the conditions outlined as per Article 9 (2)(I) of the
UK
GDPR. Processing is necessary for reasons of public interest in the area
[77 words unchanged]
To determine the clinical effectiveness of planned critical care admission after surgery.
UCL: The linkage requested is necessary for the overall objective of the
[32 words unchanged]
undergoing surgery. This is in line with Article 6 (1)(E) of the
UK
General Data Protection Regulation. UCL as a research university (public authority) can rely on this legal basis.
The data is required for research purposes - meeting the conditions outlined as per Article 9 (2)(J) of the
UK
GDPR where processing is necessary for archiving purposes in the public interest,
[85 words unchanged]
after surgery and clinical effectiveness of planned critical care admission after surgery.
[2 paragraphs unchanged]
Data will be collected by perioperative anaesthetists on all patients undergoing inpatient
[27 words unchanged]
be collected through linkage with Hospital Episode Statistics data facilitated by NHS
Digital.
England (formerly NHS Digital).
The dataset will also include patient risk factors, and questions about clinical
[18 words unchanged]
all patients undergoing inpatient surgery (elective or emergency) during the study week.
[5 paragraphs unchanged]
• The Royal College of Anaesthetists (Deputy Chief Executive Officer) will extract
[9 words unchanged]
onto a password protected Excel spreadsheet, and email this securely to NHS
Digital
England
to perform data linkage. NHS
Digital
England
will return to the Royal College of Anaesthetists a file containing the HES and MRIS data and a study id. The NHS
Digital
England
data will be linked to the EPICCS data and a pseudonymised dataset will be accessed by UCL and RCoA for analysis.
[8 paragraphs unchanged]
- be able to track longer term mortality via the MRIS
(Medical Research Information Service)
mortality tracking system;
[2 paragraphs unchanged]
Full date of death from patients in the cohort is required to
[7 words unchanged]
modelling (which requires accurate time to death following surgery duration to perform).
This came from the MRIS data.
The RCoA also requested an extract of tabulated data. This purpose of
[98 words unchanged]
across England. This was provided under a separate agreement issued by NHS
Digital.
England.
The PhD work will form part of the wider study; PhD students are often affiliated with large studies and their work will concentrate on a small section of the study. These are the study questions that will directly relate to the PhD thesis:
Data will also be accessed by:
PhD students whom will also hold Honorary Contracts with either RCoA or UCL. The individuals have completed mandatory data protection and confidentiality training and is subject to RCoA orUCLs policies on data protection and confidentiality. The individuals accessing the data will do so under the supervision of a substantive employee of RCoA or UCL. RCoA orUCL would be responsible and liable for any work carried out by the individuals. The PhD students would only work on the data for the purposes described in this Data Sharing Agreement (DSA).
The PhD work will form part of the wider study and their work will concentrate on a small section of the study. These are the study questions that will directly relate to the PhD thesis:
[4 paragraphs unchanged]
SNAP-2: EpiCCS has had patient and public involvement from inception of this study. This includes an individual patient representative, who has had several major surgical procedures and has also been a patient representative on a previous NIHR funded study sponsored by UCLH. This individual has commented on the study design, was a co-applicant on the grant, is a member of the study steering committee and has provided input to all aspects of the study including dissemination. The study has had further review of the patient information sheets by another individual, representing the Royal College of Anaesthetists’ Lay Representation Committee.
RCoA has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group, both of which have significant patient and public involvement, and will advise on how best to communicate the findings in language understandable by to the public
Processing activities
[1 paragraph unchanged]
Data from patients undergoing surgery in the UK between 21 - 27
[16 words unchanged]
the Royal College of Anaesthetists. The EPICCS IT system is stored on
UK Fast
ANS Group Limited (previously known as UKFast)
servers. This data included patient identifiable information, however data exports used by
[44 words unchanged]
order to perform linkage with HES and MRIS (Mortality) Products from NHS
Digital:
England:
[5 paragraphs unchanged]
RCoA previously sent the extract of patient identifiers to NHS
Digital
England
securely. For each patient in the list, NHS
Digital identifed
England identified
the matching HES episodes and the Mortality data from the MRIS products. NHS
Digital
England
then returned to the Royal College of Anaesthetists a file containing only the requested data and the EPICCS identifier (Study ID).
This file with NHS
Digital
England
linked data was placed in the secure RCoA server accessible only to
[59 words unchanged]
any other analysis outside of this study. No data will flow under
v1
v2
of this agreement.
The data returned from NHS
Digital
England
was linked to the EPICCS data. The pseudonymised dataset has been and
[14 words unchanged]
extension (as per v1 of this agreement) to continue the data analysis.
Data will be accessed by individuals with an honorary contract with either RCoA or UCL. The individual(s) will act as an agent of RCoA or UCL at all times under supervision from employees of RCoA or UCL. Aside from this/these individuals, access is restricted to employees or agents of RCoA or UCL who have authorisation from the Principal Investigator.
[1 paragraph unchanged]
The study will use
UKFast
ANS Group Limited
to store data. The server is hosted by
UKFast
ANS Group Limited
in a secure datacentre. All traffic passes through Cisco equipment including Anomaly
[19 words unchanged]
hardware is protected by a Cisco Firewall with full access controls enabled.
UKFast
ANS Group Limited
will carry out annual security audits. These audits will inspect the system for any vulnerabilities or threats that could allow hackers to destroy or damage the system. Each
UKFast
ANS Group Limited
datacentre is fully powered, secure, resilient and equipped to meet the project
[27 words unchanged]
need to protect systems and data from both physical and virtual threats.
UKFast
ANS Group Limited
has attained ISO-27001:2013 certification for their Information Security Management System and ISO 9001:2008 for their Quality Management System. They are
PCI
Payment Card Industry Data Security Standard (PCI)
compliant for all client transactions.
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.
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 England/Wales. The data will not leave England/Wales at any time.
[1 paragraph unchanged]
Expected output
This study will yield several research manuscripts which will be submitted to open access peer reviewed journals. Wider dissemination to the surgical and anaesthetic profession will be achieved using the resources of the RCoA and other stakeholder Royal Colleges and the NIAA-HSRC, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public. Authorship of all manuscripts will be determined by the CI, with the agreement of the Project Team (UCL and RCoA members), and comply with ICJME standards.
The expected outputs of the processing will be:
Although
• A report of findings to
the
study has not been commissioned it has received
organisations who have provided
grant funding
and support from the
which includes:
NIAA and (Association of
Aneathetists
Anaesthetists
of Great Britain and Ireland Project Grant), the RCoA and the UCLH/NIHR Biomedical Research Centre (UCL Surgical Outcomes Research Centre).
The study has further been adopted onto the NIHR Clinical Research Portfolio. Therefore all study findings will be reported to these respective organisations.
Other stakeholder organisations have been involved in study planning, including the Faculty of Intensive Care Medicine and Intensive Care
Society. These organisations
Society
will also receive
a
the report. The
report of
findings will be conducted 5 years, and then 10 years after the first data linkage (which was in 2018). Therefore,
the study
findings in order
will rely on ongoing NHS England Data linkage
to
support future healthcare policy recommendations.
the end of 10 years. This follow-up will be subject to an amended and approved agreement from NHS England.
The results of this study are likely to yield significant patient benefit in terms of outlining patient accessibility to postoperative critical care and ways this might be improved, and outcomes of the study will be disseminated by the Royal College of Anaesthetists, which has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group, both of which have significant patient and public involvement, and will advise on how best to communicate the findings in language understandable by the public. Furthermore the Royal College of Anaesthetists has a significant Communications Department which has experience in disseminating public education materials.
• Submissions to peer reviewed journals via several research manuscripts that will be open access. Three manuscripts have already been published (two in 2018 and one in 2020) however none of them involved the use of linked NHS England data. Authorship of future manuscripts will be determined by the Chief Investigator, with the agreement of the Project Team (UCL and RCoA members), and comply with International Committee of Medical Journal Editors (ICJME) standards. The submission and frequency of future manuscripts being published, is contingent on the findings of the study.
The study has yielded one published manuscript so far, and two more are in the final stages of preparation before submission to peer-reviewed journals. The first published manuscript (Wong, Harris, Moonesinghe for the SNAP-2 collaborative, British Journal of Anaesthesia, Sep 2018; https://www.ncbi.nlm.nih.gov/pubmed/30236235) led to substantial coverage in the medical and lay media (e.g.: https://www.bbc.co.uk/news/health-45432538 )
• Further presentations at national/international meetings. Presentations so far include:
The initial findings and study methodology have already been presented at several national / international meetings including:
-SG ANZICS (Asia Pacific Intensive Care Forum) (May 2018)
SG ANZICS (Asia Pacific Intensive Care Forum) (May 2018)
-EBPOM (Evidence Based Peri-Operative Medicine) Conference (July 2018)
EBPOM (Evidence Based Peri-Operative Medicine) Conference (July 2018)
-Intensive Care Society - State of the Art (December 2018)
Intensive Care Society - State of the Art (December 2018)
-Royal College of Anaesthetists – 2 conferences so far
Royal College of Anaesthetists – 2 conferences so far
• Publication of any results and reports on RCoA’s website.
The RCoA anticipate that analyses based on linked data will yield several more high-impact publications which have the potential to change clinical practice and/or policy.
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.
Data will not be used for sales and marketing purposes.
The outputs will be communicated to relevant recipients through the following dissemination channels:
All reports / results will be published on the study website and be available to participants. All published material will contain aggregated outputs only with small number suppression in line with the HES Analysis guide. No identifiable patient information will be contained within the published material.
• Journals
In addition, the research will be disseminated by:
• Webinars open to participants, including those who work within the Anaesthetists field and for anyone else who has an interest in the topic.
- Publications in open access peer reviewed scientific journals
• Social media
- Face to face presentations
• Live-action & animated video content on an open-access YouTube channel
- Live-action & animated video content on an open-access YouTube channel
• Public reports: Outcomes of the study will be disseminated by the RCoA, which has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group. They will advise on how best to communicate the findings in language understandable by the public.
- Social media
• Press/media engagement: Already received lay media coverage from BBC News in September 2018 (https://www.bbc.co.uk/news/health-45432538). Similar coverage is expected in future outputs due to the topical nature of the questions being asked surrounding the relationship between ethnicity, deprivation and outcome, including long-term outcome and resource utilisations.
- Conference presentations
• Face to Face Presentations.
- Professional literature e.g. Royal College of Anaesthetists literature
• Public promotion of the research will be achieved using the resources of the RCoA and other stakeholder Royal Colleges and the NIAA-HSRC, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public.
Expected measurable benefits
[7 paragraphs unchanged]
Answering these questions will provide opportunity to substantially improve quality of perioperative care and
our
the
understanding of the factors which influence patient outcomes after major surgery.
Publishing in peer-reviewed journals will allow greater discussion of the strengths and weaknesses of the results, and will provide the benefit of peer-review of the work from third parties. It is anticipated that the reports produced as a result of the study will contribute to clinical guidance and national policy. In particular the relevant stakeholder organisations involved in study planning will receive reports of our findings which will directly influence policy recommendations and guidelines issued by them which the Department of Health and NHS England look to for future workforce and infrastructure planning. The Royal College of Anaesthetists is a member of the Academy of Medical Royal Colleges, and therefore provides expert guidance to the Department of Health and other NHS bodies on strategic matters concerning perioperative medicine, surgery and anaesthesia. The Chief Investigator for this study is also the associate national clinical director for elective care at NHS England, and therefore has high-level access to key decision makers within the NHS in England. The study has benefitted from collaboration with over 2,800 anaesthetists, surgeons and research professionals in NHS Trusts throughout the UK, who are all directly invested in the study’s results. Any outputs will therefore be looked upon keenly by healthcare professionals closely involved in patient care at the coalface.
Publishing in peer-reviewed journals could result in
• A greater discussion of the strengths and weaknesses of the results
• Provide the benefit of peer-review of the work from third parties.
• Reports produced as a result of the study may contribute to clinical guidance and national policy. In particular the relevant stakeholder organisations involved in study planning will receive reports of the findings which could directly influence policy recommendations and guidelines issued by them which the Department of Health and NHS England look to for future workforce and infrastructure planning.
Outputs will be looked upon keenly by healthcare professionals closely involved in patient care at the coalface because of the following:
• The RCoA is a member of the Academy of Medical Royal Colleges, and therefore provides expert guidance to the Department of Health and other NHS bodies on strategic matters concerning perioperative medicine, surgery and anaesthesia.
• The Chief Investigator for this study is the associate national clinical director for elective care at NHS England, and therefore has high-level access to key decision makers within the NHS in England.
• The study has benefitted from collaboration with over 2,800 anaesthetists, surgeons and research professionals in NHS Trusts throughout the UK, who are all directly invested in the study’s results.
Benefits reported
[10 paragraphs unchanged]
A primary analysis (Aim 1) of the epidemiology of critical care admission
[46 words unchanged]
and was due to be defended later this year, before the COVID-19
pandemic
Pandemic
was declared.
Details will be provided on the outcome once available.
This body of work has now been released https://discovery.ucl.ac.uk/id/eprint/10108589/.
A paper is currently under peer review with the Public Library of Science (PLOS) Medicine journal, and a further 2 manuscripts are planned.
This work has been presented at several conferences by the Chief Investigator in both national and international meetings.
[1 paragraph unchanged]
The secondary analysis looking at the effectiveness of critical care on outcomes (Aim 2, RQ 5 and 6) is due to begin.
The 2018 cancellations paper influenced national policy, shown by the development of elective hubs and the development of enhanced perioperative care services, both of which are now national policy. It has also influenced the way in which NHS England now collects data on rates and reasons for cancellation of surgery.
A further follow-up is intended up to 10 years for longer term mortality outcomes, and these will rely on ongoing NHS Data linkage to the end of 10 years. This follow-up will be subject to an amended and approved agreement from NHS Digital.
The paper published in PLOS Medicine evaluated the performance of the Surgical Outcome Risk Tool (SORT) for predicting 30-day mortality after surgery. It is cited in national guidelines on preoperative assessment and the findings have been incorporated into a systematic review which identified the Surgical outcome risk tool (SORTsurgery.com) as the best risk model for preoperative prediction of 30day mortality after surgery worldwide (Anaesthesia Journal 2023)
The secondary analysis looking at the effectiveness of critical care on outcomes (Aim 2, RQ 5 and 6) is due to begin imminently.
DARS-NIC-88623-F2H1Q-v1.3 10 January 2020 to 9 January 2023
- Title
- MR1477 - EPIdemiology of Critical Care After Surgery (EPICCS)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); MRIS - Cause of Death Report; MRIS - Flagging Current Status Report
What changed from DARS-NIC-88623-F2H1Q-v0.15
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2020-01-10 | |
| End date | 2023-01-09 |
Objective for processing
[2 paragraphs unchanged]
After surgery, complications can sometimes occur, including mild ones like nausea, and
[31 words unchanged]
after their operation, where they can receive more intensive nursing support, or
particular
treatments not available on other hospital wards. Critical care would normally only be considered for people who are having either a very big operation, or who have
a number of
several
significant background illnesses. Previous research studies have shown that the proportion of
[29 words unchanged]
see if Critical Care admission after surgery improves patient recovery after surgery.
[1 paragraph unchanged]
The purpose of the proposed data linkage is to enable
the RCoA
The Royal College of Anaesthetsists (RCoA)
to answer research questions about the associations between postoperative morbidity, postoperative admission to a critical care unit, and longer-term outcomes for patients undergoing major (inpatient) surgery.
[2 paragraphs unchanged]
The EPIdemiology of Critical Care after Surgery (EPICCS) study aims to address
[95 words unchanged]
used to evaluate the relationship between critical care admission and postoperative outcome.
The protocol for the study has been published in the British Medical Journal: (Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 1;7(9):e017690. )
University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH) Joint Research Office, is the office which helps to administer research to both partner organisations. The Royal College of Anaesthetsists (RCoA) and UCL are the data controller for this study, as joint decisions on how to use the data rest with the RCoA and the Chief Investigator of the Project - substantively employed by University College London.
The protocol for the study has been published in the British Medical Journal: (Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 1;7(9):e017690.)
EPICCS is being jointly led (in terms of determining the study and how the analysis will be conducted) by staff at UCL and the National Institute of Academic Anaesthesia’s Health Services Research Centre (NIAA-HSRC) - who for this project are based at the RCoA. The NIAA was established in March 2008. Its vision, with respect to anaesthesia and related specialties, is to improve patient care by promoting the translation of research findings into clinical practice; develop and maximise its academic profile within the healthcare profession, NHS, universities and major research bodies; facilitate high profile, influential research; facilitate and support training and continuing professional education in academia. It is based at the RCoA (who are joint data controller and processor) , and UCL/UCLH Joint Research Office but with no role in determining how the data will be used or processed - that's decided by UCL and RCoA and funded by the Royal College of Anaesthestists, the UCL Surgical Outcomes Research Centre and the National Institute for Academic Anaesthesia. The study has been funded by these organisations on the basis of scientific merit and potential to improve patient outcomes.
University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH) Joint Research Office helps to administer research to both partner organisations. The Royal College of Anaesthetsists (RCoA) and UCL are the data controller for this study, as joint decisions on how to use the data rest with the RCoA and the Chief Investigator of the Project - substantively employed by University College London.
EPICCS is being jointly led (in terms of determining the study and how the analysis will be conducted) by staff at UCL and the National Institute of Academic Anaesthesia’s Health Services Research Centre (NIAA-HSRC) - who for this project are based at the RCoA. The NIAA was established in March 2008. Its vision, with respect to anaesthesia and related specialties, is to improve patient care by promoting the translation of research findings into clinical practice; develop and maximise its academic profile within the healthcare profession, NHS, universities and major research bodies; facilitate high profile, influential research; facilitate and support training and continuing professional education in academia. It is based at the RCoA (who are joint data controller and processor) , and UCL/UCLH Joint Research Office but with no role in determining how the data will be used or processed - that's decided by UCL and RCoA and funded by the Royal College of Anaesthestists, the UCL Surgical Outcomes Research Centre and the National Institute for Academic Anaesthesia.
The study has been funded by these organisations based on scientific merit and potential to improve patient outcomes.
[7 paragraphs unchanged]
Lawful Basis for Processing:
Royal College of Anaesthetists are processing the data in line with their charitable goals as part of their legitimate interests. This is covered under the General Data Protection Regulation Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment that The Royal College of Anaesthetists have undertaken - the data requested is to help achieve the following: "Scientific and Statistical Research - particularly in regards to anaesthesia, as the college is the professional representative body . Anaesthetists, have overall responsibility for patients' well-being before, during and after surgery, and research such as EPICCS is integral to monitor and investigate this.
The data is also required for service evaluation purposes - meeting the conditions outlined as per Article 9 (2)(I) of the GDPR. Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy. The Royal College of Anaesthetists are carrying out service evaluation work as described in this agreement to To determine the clinical effectiveness of planned critical care admission after surgery.
UCL: The linkage requested is necessary for the overall objective of the study and also for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller - 'helping improve care for people undergoing surgery. This is in line with Article 6 (1)(E) of the General Data Protection Regulation. UCL as a research university (public authority) can rely on this legal basis.
The data is required for research purposes - meeting the conditions outlined as per Article 9 (2)(J) of the GDPR where 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. University College London (UCL) are carrying out research work as described in this agreement to investigate and answer various research questions into describing the epidemiology of critical care admission after surgery and clinical effectiveness of planned critical care admission after surgery.
[21 paragraphs unchanged]
The RCoA
are
also
requesting
requested
an extract of tabulated data. This purpose of this
is
was
to obtain total number of surgical procedures carried out in England during
[75 words unchanged]
on a representative number of surgical operations being conducted across England. This
will be
was
provided under a separate agreement issued by NHS Digital.
The PhD work will form part of the wider
study,
study;
PhD students are often affiliated with large studies and their work will
[9 words unchanged]
are the study questions that will directly relate to the PhD thesis:
1.How
1. How
do clinicians determine the risk of postoperative mortality in clinical practice?
[2 paragraphs unchanged]
4. What factors influence whether patients
actually
receive planned postoperative critical care?
Processing activities
[1 paragraph unchanged]
Data from patients undergoing surgery in the UK between 21 - 27
[63 words unchanged]
at the Royal College of Anaesthetists (Deputy Chief Executive Officer). Patient identifiers
will be
were
extracted from the database, which
will contain
contained
the following identifiers in order to perform linkage with HES and MRIS (Mortality) Products from NHS Digital:
[5 paragraphs unchanged]
RCoA
will send
previously sent
the
data
extract
of patient identifiers
to NHS Digital securely. For each patient in the
data extract,
list,
NHS Digital
will identify
identifed
the matching HES episodes and the Mortality data from the MRIS products. NHS Digital
will
then
return
returned
to the Royal College of Anaesthetists a file containing only the requested data and the EPICCS identifier (Study ID).
This file with NHS Digital linked data
will be
was
placed in the secure RCoA server accessible only to the project data manager, a substantive employee of RCoA, and
will
did
not contain NHS number, postcode or date of birth. The dataset
will be
was
analysed by the RCoA to produce results for EPICCS reports and other EPICCS outputs, but
was not and
will not be relinked or used in conjunction with any other data to re-identify patients or to perform any other analysis outside of this study.
No data will flow under v1 of this agreement.
The data returned from NHS Digital
will be
was
linked to the EPICCS
data and this
data. The
pseudonymised dataset
has been and
will be accessed by UCL and RCoA for
analysis only. The applicants require an extension (as per v1 of this agreement) to continue the data
analysis.
[3 paragraphs unchanged]
Expected output
[19 paragraphs unchanged]
The aim will be to publish the first manuscript which uses NHS Digital data within 12 months of receipt of the data.
Expected measurable benefits
[1 paragraph unchanged]
Policy: Do we have sufficient numbers of critical care beds to meet the demand from surgery and to provide a high quality service?
Policy:
Are surgical patients in hospitals where there is increased demand for critical care beds disadvantaged?
- Is there a sufficient numbers of critical care beds to meet the demand from surgery and to provide a high quality service?
- Are surgical patients in hospitals where there is increased demand for critical care beds disadvantaged?
[1 paragraph unchanged]
-
Do current methods of risk prediction accurately predict short and longer term outcome after surgery?
-
Is critical care an effective intervention to prevent postoperative complications?
[2 paragraphs unchanged]
Benefits reported
Yielded Benefits is not a requirement for new applications.
Study intended aims:
1. To describe the epidemiology of critical care admission after surgery
2. To determine the clinical effectiveness of planned critical care admission after surgery
Research Questions (RQ)
1. How do clinicians determine the risk of postoperative mortality in clinical practice?
2. Do previously validated risk stratification tools accurately predict postoperative mortality?
3. On what basis do clinicians refer patients for planned postoperative critical care?
4. What factors influence whether patients actually receive planned postoperative critical care?
5. Does immediate critical care admission reduce postoperative morbidity and mortality?
6. Does short-term morbidity independently predict longer term mortality?
A primary analysis (Aim 1) of the epidemiology of critical care admission has been completed, factors which influence clinician referral to critical care (RQ3 and 4), capacity and needs assessment for critical care after inpatient surgery (RQ4), and accuracy of clinician perioperative risk prediction (RQ1 and 2). This body of work has been submitted as a PhD thesis and was due to be defended later this year, before the COVID-19 pandemic was declared. Details will be provided on the outcome once available.
A paper is currently under peer review with the Public Library of Science (PLOS) Medicine journal, and a further 2 manuscripts are planned.
This work has been presented at several conferences by the Chief Investigator in both national and international meetings.
The work has also influenced policy on a national scale in the UK with regards to critical care provision in enhance care wards (due to be published by the Faculty of Intensive Care Medicine and Royal College of Physicians, London).
The secondary analysis looking at the effectiveness of critical care on outcomes (Aim 2, RQ 5 and 6) is due to begin.
A further follow-up is intended up to 10 years for longer term mortality outcomes, and these will rely on ongoing NHS Data linkage to the end of 10 years. This follow-up will be subject to an amended and approved agreement from NHS Digital.
Objective for processing
The Sprint National Anaesthesia Projects (SNAPs) are 'snapshot' evaluation studies of clinical activity and patient-centred outcomes that are important and relevant to both patients and anaesthetists.
The 2nd Sprint National Anaesthesia Project: Epidemiology of Critical Care provision after Surgery (SNAP-2: EpiCCS) will describe the epidemiology of perioperative risk and outcome, and critical care referral and admission after inpatient surgery in the UK. It also aims to examine whether planned postoperative critical care admission is effective as an intervention to reduce postoperative morbidity.
After surgery, complications can sometimes occur, including mild ones like nausea, and more major ones such as infections, and very rarely death. One way which may help to prevent complications in some patients is to admit patients to a Critical Care Unit (CCU) after their operation, where they can receive more intensive nursing support, or treatments not available on other hospital wards. Critical care would normally only be considered for people who are having either a very big operation, or who have several significant background illnesses. Previous research studies have shown that the proportion of patients admitted to CCU after surgery differs between hospitals and countries. The study has been conducted to try and uncover some of the reasons for these findings, and to see if Critical Care admission after surgery improves patient recovery after surgery.
The overall aim of the study is to help improve care for people undergoing surgery.
The purpose of the proposed data linkage is to enable The Royal College of Anaesthetsists (RCoA) to answer research questions about the associations between postoperative morbidity, postoperative admission to a critical care unit, and longer-term outcomes for patients undergoing major (inpatient) surgery.
Background:
The admission of high-risk patients to critical care after surgery is a recommended standard of care. Nevertheless, poor compliance against this recommendation has been repeatedly demonstrated in large epidemiological studies. It is unclear whether this is due to reasons of capacity, equipoise, poor quality clinical care or because hospitals are working creatively to create capacity for augmented care on normal surgical wards. Importantly, the clinical effectiveness of critical care as an ‘intervention’ is uncertain, and the threshold for admission to critical care (i.e. the risk profile of patients who might benefit) is currently based on expert opinion rather than research.
The EPIdemiology of Critical Care after Surgery (EPICCS) study aims to address these uncertainties. The study is a one-week observational cohort study including all patients who underwent inpatient (overnight stay) surgery between March 21st - 27th 2017. All patients had prospective data collection on risk factors, surgical procedure and postoperative outcomes including the primary outcome of morbidity (measured using the Postoperative Morbidity Survey on day 7 after surgery) and secondary outcomes including length of stay and inpatient mortality. The epidemiology of patient characteristics, processes and outcomes will be described once analysis is conducted. Inferential techniques (multilevel multivariable regression, propensity score matching and instrumental variable analysis) will be used to evaluate the relationship between critical care admission and postoperative outcome.
The protocol for the study has been published in the British Medical Journal: (Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 1;7(9):e017690.)
University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH) Joint Research Office helps to administer research to both partner organisations. The Royal College of Anaesthetsists (RCoA) and UCL are the data controller for this study, as joint decisions on how to use the data rest with the RCoA and the Chief Investigator of the Project - substantively employed by University College London.
EPICCS is being jointly led (in terms of determining the study and how the analysis will be conducted) by staff at UCL and the National Institute of Academic Anaesthesia’s Health Services Research Centre (NIAA-HSRC) - who for this project are based at the RCoA. The NIAA was established in March 2008. Its vision, with respect to anaesthesia and related specialties, is to improve patient care by promoting the translation of research findings into clinical practice; develop and maximise its academic profile within the healthcare profession, NHS, universities and major research bodies; facilitate high profile, influential research; facilitate and support training and continuing professional education in academia. It is based at the RCoA (who are joint data controller and processor) , and UCL/UCLH Joint Research Office but with no role in determining how the data will be used or processed - that's decided by UCL and RCoA and funded by the Royal College of Anaesthestists, the UCL Surgical Outcomes Research Centre and the National Institute for Academic Anaesthesia.
The study has been funded by these organisations based on scientific merit and potential to improve patient outcomes.
Aim:
1. To describe the epidemiology of critical care admission after surgery
2. To determine the clinical effectiveness of planned critical care admission after surgery
Research Questions pertinent to this application
1. Do previously validated risk stratification tools accurately predict postoperative mortality?
2. Does immediate critical care admission reduce postoperative morbidity and mortality?
3. Does short-term morbidity independently predict longer term mortality and other adverse outcomes (e.g. hospital readmission)?
Lawful Basis for Processing:
Royal College of Anaesthetists are processing the data in line with their charitable goals as part of their legitimate interests. This is covered under the General Data Protection Regulation Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment that The Royal College of Anaesthetists have undertaken - the data requested is to help achieve the following: "Scientific and Statistical Research - particularly in regards to anaesthesia, as the college is the professional representative body . Anaesthetists, have overall responsibility for patients' well-being before, during and after surgery, and research such as EPICCS is integral to monitor and investigate this.
The data is also required for service evaluation purposes - meeting the conditions outlined as per Article 9 (2)(I) of the GDPR. Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy. The Royal College of Anaesthetists are carrying out service evaluation work as described in this agreement to To determine the clinical effectiveness of planned critical care admission after surgery.
UCL: The linkage requested is necessary for the overall objective of the study and also for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller - 'helping improve care for people undergoing surgery. This is in line with Article 6 (1)(E) of the General Data Protection Regulation. UCL as a research university (public authority) can rely on this legal basis.
The data is required for research purposes - meeting the conditions outlined as per Article 9 (2)(J) of the GDPR where 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. University College London (UCL) are carrying out research work as described in this agreement to investigate and answer various research questions into describing the epidemiology of critical care admission after surgery and clinical effectiveness of planned critical care admission after surgery.
STUDY DESIGN
EpiCCS is a one-week, prospective observational cohort study of patients and anaesthetists in NHS hospitals. It incorporates the following:
Data will be collected by perioperative anaesthetists on all patients undergoing inpatient surgery in participating UK hospitals for one week. Postoperative morbidity will be recorded for patients who remain in hospital on Day 7 after surgery. Mortality data will be collected through linkage with Hospital Episode Statistics data facilitated by NHS Digital. The dataset will also include patient risk factors, and questions about clinical decision-making and resource availability related to critical care referral and admission. The main EPICCS patient study will include all patients undergoing inpatient surgery (elective or emergency) during the study week.
Additionally, an organisational questionnaire for each hospital will be completed to describe structure and process in those institutions, the number and reasons for any cancellations of surgery during the study, and critical care unit occupancy at regular time-intervals throughout the one-week data collection period. The epidemiology of perioperative risk stratification, postoperative care and patient outcome will be described. Multivariable regression, instrumental variable and propensity score matched analyses will be conducted to ascertain the clinical effectiveness of postoperative critical care admission in reducing adverse outcomes after inpatient surgery.
A survey of anaesthetists and surgeons on their attitudes and behaviours regarding risk prediction and postoperative critical care admission. All anaesthetists and surgeons who undertake perioperative care for inpatient surgery during the study period will be invited to participate.
At the time of data-entry onto the EpiCCS webtool, confidential patient information will be retained and stored securely in their original format within the database, however different database access privileges (dependent on usernames and passwords) will apply to different users of the database:
• Local investigators within NHS Trusts will have access to their own full datasets, including patient identifiable information.
• The central EpiCCS study team will only have access to an anonymised dataset for analysis. Among the patient identifiers, only sex will be used for analysis. In this dataset the NHS number will be replaced by a unique study patient identifier; Date of Birth will be converted to Age on date of surgery, and trimmed to month and year of birth; Postcode will be converted to PCT, SHA of residence, and the Office for National Statistics Lower Super Output Area, which allows the allocation of the Index of Multiple Deprivation.
• The Royal College of Anaesthetists (Deputy Chief Executive Officer) will extract the required patient identifiable data from the study database onto a password protected Excel spreadsheet, and email this securely to NHS Digital to perform data linkage. NHS Digital will return to the Royal College of Anaesthetists a file containing the HES and MRIS data and a study id. The NHS Digital data will be linked to the EPICCS data and a pseudonymised dataset will be accessed by UCL and RCoA for analysis.
EPICCS was a one-week, prospective observational cohort study of patients undergoing inpatient surgery in participating hospitals. The study recruited 22,993 patients for one week in March 2017 (patient recruitment phase), in a total of 245 NHS Hospitals throughout the UK with a planned follow-up of 10 years (to track longer-term survival). Recruitment has now therefore finished.
Eligibility criteria
All UK NHS hospitals which undertake inpatient surgery were eligible to take part. All UK hospitals are eligible but it is only those hospitals with patients in critical care during the one week outlined in the application that participate in the study.
Inclusion criteria:
Adult (>=18 years) patients undergoing surgery or other interventions who were expected to require overnight stay in hospital which require the support of an anaesthetist. These would include all procedures taking place in an operating theatre, radiology suite, endoscopy suite or catheter laboratory for which inpatient (overnight) stay is planned, including both planned and emergency/urgent surgery of all types, Caesarean section, surgery for complications of childbirth, endoscopy and interventional radiology procedures.
Exclusion criteria:
Patients who indicated they do not want to participate in the study; Ambulatory surgery; children (<18 years); non-surgical obstetrics; ASA-PS grade VI; non-interventional diagnostic imaging (e.g. CT or MRI scanning without interventions); emergency department or critical care interventions requiring anaesthesia or sedation but no interventional procedure
The purpose of patient-level data linkage is to:
- be able to track longer term mortality via the MRIS mortality tracking system;
- to report hospital readmission (rates and reasons) through linkage with HES data.
HES APC and CC data are required to determine rates and reasons for readmission to hospital after the initial discharge following surgery. Hospital readmission is a complication of surgery which should be included in any outcome analysis.
Full date of death from patients in the cohort is required to track patient outcomes and for survival analysis modelling (which requires accurate time to death following surgery duration to perform).
The RCoA also requested an extract of tabulated data. This purpose of this was to obtain total number of surgical procedures carried out in England during the study period in hospitals participating in the 2nd Sprint National Anaesthesia Project: EPIdemiology of Critical Care provision after Surgery - during 21st March 2017 and 27th March 2017. The number of procedures for each procedure code should be tallied for each hospital. These data will then be compared against the total number of cases recruited to the SNAP-2: EPICCS study in order to identify how accurate the sampling strategy has been in capturing data on a representative number of surgical operations being conducted across England. This was provided under a separate agreement issued by NHS Digital.
The PhD work will form part of the wider study; PhD students are often affiliated with large studies and their work will concentrate on a small section of the study. These are the study questions that will directly relate to the PhD thesis:
1. How do clinicians determine the risk of postoperative mortality in clinical practice?
2. Do previously validated risk stratification tools accurately predict postoperative mortality?
3. On what basis do clinicians refer patients for planned postoperative critical care?
4. What factors influence whether patients receive planned postoperative critical care?
Expected output
This study will yield several research manuscripts which will be submitted to open access peer reviewed journals. Wider dissemination to the surgical and anaesthetic profession will be achieved using the resources of the RCoA and other stakeholder Royal Colleges and the NIAA-HSRC, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public. Authorship of all manuscripts will be determined by the CI, with the agreement of the Project Team (UCL and RCoA members), and comply with ICJME standards.
Although the study has not been commissioned it has received grant funding and support from the NIAA and (Association of Aneathetists of Great Britain and Ireland Project Grant), the RCoA and the UCLH/NIHR Biomedical Research Centre (UCL Surgical Outcomes Research Centre). The study has further been adopted onto the NIHR Clinical Research Portfolio. Therefore all study findings will be reported to these respective organisations. Other stakeholder organisations have been involved in study planning, including the Faculty of Intensive Care Medicine and Intensive Care Society. These organisations will also receive a report of the study findings in order to support future healthcare policy recommendations.
The results of this study are likely to yield significant patient benefit in terms of outlining patient accessibility to postoperative critical care and ways this might be improved, and outcomes of the study will be disseminated by the Royal College of Anaesthetists, which has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group, both of which have significant patient and public involvement, and will advise on how best to communicate the findings in language understandable by the public. Furthermore the Royal College of Anaesthetists has a significant Communications Department which has experience in disseminating public education materials.
The study has yielded one published manuscript so far, and two more are in the final stages of preparation before submission to peer-reviewed journals. The first published manuscript (Wong, Harris, Moonesinghe for the SNAP-2 collaborative, British Journal of Anaesthesia, Sep 2018; https://www.ncbi.nlm.nih.gov/pubmed/30236235) led to substantial coverage in the medical and lay media (e.g.: https://www.bbc.co.uk/news/health-45432538 )
The initial findings and study methodology have already been presented at several national / international meetings including:
SG ANZICS (Asia Pacific Intensive Care Forum) (May 2018)
EBPOM (Evidence Based Peri-Operative Medicine) Conference (July 2018)
Intensive Care Society - State of the Art (December 2018)
Royal College of Anaesthetists – 2 conferences so far
The RCoA anticipate that analyses based on linked data will yield several more high-impact publications which have the potential to change clinical practice and/or policy.
Data will not be used for sales and marketing purposes.
All reports / results will be published on the study website and be available to participants. All published material will contain aggregated outputs only with small number suppression in line with the HES Analysis guide. No identifiable patient information will be contained within the published material.
In addition, the research will be disseminated by:
- Publications in open access peer reviewed scientific journals
- Face to face presentations
- Live-action & animated video content on an open-access YouTube channel
- Social media
- Conference presentations
- Professional literature e.g. Royal College of Anaesthetists literature
Benefits reported
Study intended aims:
1. To describe the epidemiology of critical care admission after surgery
2. To determine the clinical effectiveness of planned critical care admission after surgery
Research Questions (RQ)
1. How do clinicians determine the risk of postoperative mortality in clinical practice?
2. Do previously validated risk stratification tools accurately predict postoperative mortality?
3. On what basis do clinicians refer patients for planned postoperative critical care?
4. What factors influence whether patients actually receive planned postoperative critical care?
5. Does immediate critical care admission reduce postoperative morbidity and mortality?
6. Does short-term morbidity independently predict longer term mortality?
A primary analysis (Aim 1) of the epidemiology of critical care admission has been completed, factors which influence clinician referral to critical care (RQ3 and 4), capacity and needs assessment for critical care after inpatient surgery (RQ4), and accuracy of clinician perioperative risk prediction (RQ1 and 2). This body of work has been submitted as a PhD thesis and was due to be defended later this year, before the COVID-19 pandemic was declared. Details will be provided on the outcome once available.
A paper is currently under peer review with the Public Library of Science (PLOS) Medicine journal, and a further 2 manuscripts are planned.
This work has been presented at several conferences by the Chief Investigator in both national and international meetings.
The work has also influenced policy on a national scale in the UK with regards to critical care provision in enhance care wards (due to be published by the Faculty of Intensive Care Medicine and Royal College of Physicians, London).
The secondary analysis looking at the effectiveness of critical care on outcomes (Aim 2, RQ 5 and 6) is due to begin.
A further follow-up is intended up to 10 years for longer term mortality outcomes, and these will rely on ongoing NHS Data linkage to the end of 10 years. This follow-up will be subject to an amended and approved agreement from NHS Digital.
DARS-NIC-88623-F2H1Q-v0.15 10 January 2019 to 9 January 2020
- Title
- MR1477 - EPIdemiology of Critical Care After Surgery (EPICCS)
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 6
Datasets: Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); MRIS - Cause of Death Report; MRIS - Flagging Current Status Report
Objective for processing
The Sprint National Anaesthesia Projects (SNAPs) are 'snapshot' evaluation studies of clinical activity and patient-centred outcomes that are important and relevant to both patients and anaesthetists.
The 2nd Sprint National Anaesthesia Project: Epidemiology of Critical Care provision after Surgery (SNAP-2: EpiCCS) will describe the epidemiology of perioperative risk and outcome, and critical care referral and admission after inpatient surgery in the UK. It also aims to examine whether planned postoperative critical care admission is effective as an intervention to reduce postoperative morbidity.
After surgery, complications can sometimes occur, including mild ones like nausea, and more major ones such as infections, and very rarely death. One way which may help to prevent complications in some patients is to admit patients to a Critical Care Unit (CCU) after their operation, where they can receive more intensive nursing support, or particular treatments not available on other hospital wards. Critical care would normally only be considered for people who are having either a very big operation, or who have a number of significant background illnesses. Previous research studies have shown that the proportion of patients admitted to CCU after surgery differs between hospitals and countries. The study has been conducted to try and uncover some of the reasons for these findings, and to see if Critical Care admission after surgery improves patient recovery after surgery.
The overall aim of the study is to help improve care for people undergoing surgery.
The purpose of the proposed data linkage is to enable the RCoA to answer research questions about the associations between postoperative morbidity, postoperative admission to a critical care unit, and longer-term outcomes for patients undergoing major (inpatient) surgery.
Background:
The admission of high-risk patients to critical care after surgery is a recommended standard of care. Nevertheless, poor compliance against this recommendation has been repeatedly demonstrated in large epidemiological studies. It is unclear whether this is due to reasons of capacity, equipoise, poor quality clinical care or because hospitals are working creatively to create capacity for augmented care on normal surgical wards. Importantly, the clinical effectiveness of critical care as an ‘intervention’ is uncertain, and the threshold for admission to critical care (i.e. the risk profile of patients who might benefit) is currently based on expert opinion rather than research.
The EPIdemiology of Critical Care after Surgery (EPICCS) study aims to address these uncertainties. The study is a one-week observational cohort study including all patients who underwent inpatient (overnight stay) surgery between March 21st - 27th 2017. All patients had prospective data collection on risk factors, surgical procedure and postoperative outcomes including the primary outcome of morbidity (measured using the Postoperative Morbidity Survey on day 7 after surgery) and secondary outcomes including length of stay and inpatient mortality. The epidemiology of patient characteristics, processes and outcomes will be described once analysis is conducted. Inferential techniques (multilevel multivariable regression, propensity score matching and instrumental variable analysis) will be used to evaluate the relationship between critical care admission and postoperative outcome. The protocol for the study has been published in the British Medical Journal: (Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 1;7(9):e017690. )
University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH) Joint Research Office, is the office which helps to administer research to both partner organisations. The Royal College of Anaesthetsists (RCoA) and UCL are the data controller for this study, as joint decisions on how to use the data rest with the RCoA and the Chief Investigator of the Project - substantively employed by University College London.
EPICCS is being jointly led (in terms of determining the study and how the analysis will be conducted) by staff at UCL and the National Institute of Academic Anaesthesia’s Health Services Research Centre (NIAA-HSRC) - who for this project are based at the RCoA. The NIAA was established in March 2008. Its vision, with respect to anaesthesia and related specialties, is to improve patient care by promoting the translation of research findings into clinical practice; develop and maximise its academic profile within the healthcare profession, NHS, universities and major research bodies; facilitate high profile, influential research; facilitate and support training and continuing professional education in academia. It is based at the RCoA (who are joint data controller and processor) , and UCL/UCLH Joint Research Office but with no role in determining how the data will be used or processed - that's decided by UCL and RCoA and funded by the Royal College of Anaesthestists, the UCL Surgical Outcomes Research Centre and the National Institute for Academic Anaesthesia. The study has been funded by these organisations on the basis of scientific merit and potential to improve patient outcomes.
Aim:
1. To describe the epidemiology of critical care admission after surgery
2. To determine the clinical effectiveness of planned critical care admission after surgery
Research Questions pertinent to this application
1. Do previously validated risk stratification tools accurately predict postoperative mortality?
2. Does immediate critical care admission reduce postoperative morbidity and mortality?
3. Does short-term morbidity independently predict longer term mortality and other adverse outcomes (e.g. hospital readmission)?
Study design
EpiCCS is a one-week, prospective observational cohort study of patients and anaesthetists in NHS hospitals. It incorporates the following:
Data will be collected by perioperative anaesthetists on all patients undergoing inpatient surgery in participating UK hospitals for one week. Postoperative morbidity will be recorded for patients who remain in hospital on Day 7 after surgery. Mortality data will be collected through linkage with Hospital Episode Statistics data facilitated by NHS Digital. The dataset will also include patient risk factors, and questions about clinical decision-making and resource availability related to critical care referral and admission. The main EPICCS patient study will include all patients undergoing inpatient surgery (elective or emergency) during the study week.
Additionally, an organisational questionnaire for each hospital will be completed to describe structure and process in those institutions, the number and reasons for any cancellations of surgery during the study, and critical care unit occupancy at regular time-intervals throughout the one-week data collection period. The epidemiology of perioperative risk stratification, postoperative care and patient outcome will be described. Multivariable regression, instrumental variable and propensity score matched analyses will be conducted to ascertain the clinical effectiveness of postoperative critical care admission in reducing adverse outcomes after inpatient surgery.
A survey of anaesthetists and surgeons on their attitudes and behaviours regarding risk prediction and postoperative critical care admission. All anaesthetists and surgeons who undertake perioperative care for inpatient surgery during the study period will be invited to participate.
At the time of data-entry onto the EpiCCS webtool, confidential patient information will be retained and stored securely in their original format within the database, however different database access privileges (dependent on usernames and passwords) will apply to different users of the database:
• Local investigators within NHS Trusts will have access to their own full datasets, including patient identifiable information.
• The central EpiCCS study team will only have access to an anonymised dataset for analysis. Among the patient identifiers, only sex will be used for analysis. In this dataset the NHS number will be replaced by a unique study patient identifier; Date of Birth will be converted to Age on date of surgery, and trimmed to month and year of birth; Postcode will be converted to PCT, SHA of residence, and the Office for National Statistics Lower Super Output Area, which allows the allocation of the Index of Multiple Deprivation.
• The Royal College of Anaesthetists (Deputy Chief Executive Officer) will extract the required patient identifiable data from the study database onto a password protected Excel spreadsheet, and email this securely to NHS Digital to perform data linkage. NHS Digital will return to the Royal College of Anaesthetists a file containing the HES and MRIS data and a study id. The NHS Digital data will be linked to the EPICCS data and a pseudonymised dataset will be accessed by UCL and RCoA for analysis.
EPICCS was a one-week, prospective observational cohort study of patients undergoing inpatient surgery in participating hospitals. The study recruited 22,993 patients for one week in March 2017 (patient recruitment phase), in a total of 245 NHS Hospitals throughout the UK with a planned follow-up of 10 years (to track longer-term survival). Recruitment has now therefore finished.
Eligibility criteria
All UK NHS hospitals which undertake inpatient surgery were eligible to take part. All UK hospitals are eligible but it is only those hospitals with patients in critical care during the one week outlined in the application that participate in the study.
Inclusion criteria:
Adult (>=18 years) patients undergoing surgery or other interventions who were expected to require overnight stay in hospital which require the support of an anaesthetist. These would include all procedures taking place in an operating theatre, radiology suite, endoscopy suite or catheter laboratory for which inpatient (overnight) stay is planned, including both planned and emergency/urgent surgery of all types, Caesarean section, surgery for complications of childbirth, endoscopy and interventional radiology procedures.
Exclusion criteria:
Patients who indicated they do not want to participate in the study; Ambulatory surgery; children (<18 years); non-surgical obstetrics; ASA-PS grade VI; non-interventional diagnostic imaging (e.g. CT or MRI scanning without interventions); emergency department or critical care interventions requiring anaesthesia or sedation but no interventional procedure
The purpose of patient-level data linkage is to:
- be able to track longer term mortality via the MRIS mortality tracking system;
- to report hospital readmission (rates and reasons) through linkage with HES data.
HES APC and CC data are required to determine rates and reasons for readmission to hospital after the initial discharge following surgery. Hospital readmission is a complication of surgery which should be included in any outcome analysis.
Full date of death from patients in the cohort is required to track patient outcomes and for survival analysis modelling (which requires accurate time to death following surgery duration to perform).
The RCoA are also requesting an extract of tabulated data. This purpose of this is to obtain total number of surgical procedures carried out in England during the study period in hospitals participating in the 2nd Sprint National Anaesthesia Project: EPIdemiology of Critical Care provision after Surgery - during 21st March 2017 and 27th March 2017. The number of procedures for each procedure code should be tallied for each hospital. These data will then be compared against the total number of cases recruited to the SNAP-2: EPICCS study in order to identify how accurate the sampling strategy has been in capturing data on a representative number of surgical operations being conducted across England. This will be provided under a separate agreement issued by NHS Digital.
The PhD work will form part of the wider study, PhD students are often affiliated with large studies and their work will concentrate on a small section of the study. These are the study questions that will directly relate to the PhD thesis:
1.How do clinicians determine the risk of postoperative mortality in clinical practice?
2. Do previously validated risk stratification tools accurately predict postoperative mortality?
3. On what basis do clinicians refer patients for planned postoperative critical care?
4. What factors influence whether patients actually receive planned postoperative critical care?
Expected output
This study will yield several research manuscripts which will be submitted to open access peer reviewed journals. Wider dissemination to the surgical and anaesthetic profession will be achieved using the resources of the RCoA and other stakeholder Royal Colleges and the NIAA-HSRC, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public. Authorship of all manuscripts will be determined by the CI, with the agreement of the Project Team (UCL and RCoA members), and comply with ICJME standards.
Although the study has not been commissioned it has received grant funding and support from the NIAA and (Association of Aneathetists of Great Britain and Ireland Project Grant), the RCoA and the UCLH/NIHR Biomedical Research Centre (UCL Surgical Outcomes Research Centre). The study has further been adopted onto the NIHR Clinical Research Portfolio. Therefore all study findings will be reported to these respective organisations. Other stakeholder organisations have been involved in study planning, including the Faculty of Intensive Care Medicine and Intensive Care Society. These organisations will also receive a report of the study findings in order to support future healthcare policy recommendations.
The results of this study are likely to yield significant patient benefit in terms of outlining patient accessibility to postoperative critical care and ways this might be improved, and outcomes of the study will be disseminated by the Royal College of Anaesthetists, which has a Lay Committee panel and Patient, Carer & Public Involvement & Engagement (PCPIE) group, both of which have significant patient and public involvement, and will advise on how best to communicate the findings in language understandable by the public. Furthermore the Royal College of Anaesthetists has a significant Communications Department which has experience in disseminating public education materials.
The study has yielded one published manuscript so far, and two more are in the final stages of preparation before submission to peer-reviewed journals. The first published manuscript (Wong, Harris, Moonesinghe for the SNAP-2 collaborative, British Journal of Anaesthesia, Sep 2018; https://www.ncbi.nlm.nih.gov/pubmed/30236235) led to substantial coverage in the medical and lay media (e.g.: https://www.bbc.co.uk/news/health-45432538 )
The initial findings and study methodology have already been presented at several national / international meetings including:
SG ANZICS (Asia Pacific Intensive Care Forum) (May 2018)
EBPOM (Evidence Based Peri-Operative Medicine) Conference (July 2018)
Intensive Care Society - State of the Art (December 2018)
Royal College of Anaesthetists – 2 conferences so far
The RCoA anticipate that analyses based on linked data will yield several more high-impact publications which have the potential to change clinical practice and/or policy.
Data will not be used for sales and marketing purposes.
All reports / results will be published on the study website and be available to participants. All published material will contain aggregated outputs only with small number suppression in line with the HES Analysis guide. No identifiable patient information will be contained within the published material.
In addition, the research will be disseminated by:
- Publications in open access peer reviewed scientific journals
- Face to face presentations
- Live-action & animated video content on an open-access YouTube channel
- Social media
- Conference presentations
- Professional literature e.g. Royal College of Anaesthetists literature
The aim will be to publish the first manuscript which uses NHS Digital data within 12 months of receipt of the data.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.
-
July 2021 —
already listed in the earliest edition this site holds, so it may be older. 2 versions: DARS-NIC-88623-F2H1Q-v0.15, DARS-NIC-88623-F2H1Q-v1.3
-
December 2022
Register-wide edit DARS-NIC-88623-F2H1Q-v0.15, DARS-NIC-88623-F2H1Q-v1.3 — Datasets: legal basis: “
s261(1) and” taken out. Made to 639 agreements in this edition, so it is reported once, on the changes page, and not counted as an amendment of this agreement. -
January 2024
1 version added: DARS-NIC-88623-F2H1Q-v2.9
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-88623-F2H1Q, “MR1477 - EPIdemiology of Critical Care After Surgery (EPICCS)”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-88623-f2h1q/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-88623-F2H1Q to see the original rows.