NHS Digital Data Release Register - reformatted

Queen Mary University Of London

Project 1 — DARS-NIC-147843-8NKTW

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

The aim of the trial is to determine whether healthy people should be screened and treated for H Pylori infection.


Project 2 — DARS-NIC-25945-T8Q0Z

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/09 — 2017/02.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Flagging Current Status Report
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Outpatients
  • MRIS - Cohort Event Notification Report

Benefits:

The BEST2 study recruited 1344 men and women within the UK with either known Barrett's Oesophagus (cases) or individuals with reflux or indigestion symptoms referred for endoscopy (controls). All participants were screened with the Cytosponge™ device to test its potential in determining the risk of cancer progression (in conjunction with biomarkers of risk). The results were then compared to routine endoscopy findings. The study objectives are as follows: Primary objectives QMUL are interested in obtaining the data from these patients to link the biomarker work performed on the samples collected and the risk of progression to cancer. Performance and safety characteristics of the Cytosponge™ test Effectiveness of the Cytosponge™ for diagnosing BE compared with endoscopy, including specificity (from controls) and sensitivity (from cases) For patients with BE, the ability of Cytosponge™ biomarkers to risk stratify patients, according to their future cancer risk in comparison with the dysplasia grade obtained from endoscopic biopsies. Secondary objectives Differential sensitivity of screening BE with dysplasia (low and high grade) compared to non-dysplastic BE. Determine the reproducibility of the Cytosponge™ result by repeated testing in a subset of individuals Logistics of high-throughput sample processing and automated analysis of Cytosponge™ specimens for use in routine NHS or other health care settings. Surplus material will be used for testing emerging biomarkers. Analysis of NHS records will help measure long term effectiveness of the Cytosponge biomarkers to risk stratify patients. In addition to identifying its efficacy in an NHS setting as an alternative to endoscopies. The potential benefits of this research include reducing the use of invasive procedures for patients and by providing evidence for policy decision makers for the use of a safe, minimally invasive, cheaper, and easily administered method to diagnose and screen for this condition A target date has not yet been assessed due to the unknown level of data expected to be received as processing time cannot be estimated yet.

Outputs:

Data outputs produced will not contain any patient identifiable data or be shared with any third party organisation. The only outputs produced will be publications for research purposes using aggregated data with small number suppression in line with the HES Analysis Guide. At this point in time, QMUL cannot comment on the name of journal or conferences as it will depend on the result. Possible journals include PLOS Medicine, Gastroenterology or Gut. The conferences would be Digestive Disease Week and/or United European Gastroenterology Week. It is not yet possible to give a time frame as the length of time to obtain the data has already extended longer than anticipated but once data has been received QMUL expect processing to be completed in around 4-6 months.

Processing:

The data will be processed jointly by Cambridge university and the data controller QMUL. Cambridge university will send the cohort data to the HSCIC for data linkage. Once returned from the HSCIC Cambridge will integrate the data into their database updating any new patient information. Then the identifiable information received from the HSCIC will be removed by Cambridge and this anonymised data set will be sent (via secure encrypted data transfer) to QMUL linked via a unique identifier. QMUL will use this data to link baseline Cytosponge™ findings to disease progression. The following outcomes will be monitored; Barrett’s oseophagus, Barrett’s high grade dysplasia, adenocarcinoma of the oesophagus, squamous cell carcinoma of the oesophagus and oesophageal cancer. All data received at the QMUL Centre for Cancer Prevention, (CCP), are stored electronically on an Oracle database (Oracle 11g). The system is self-contained within the Barts Cancer Research Centre (QMUL) network, within the Queen Mary University of London (QMUL) network, but firewalled off from the rest of the network, in addition to external connections.

Objectives:

The BEST2 study was set up to investigate the safety and performance of the Cytosponge™ test for diagnosing Barrett's Oesophagus (BE) over three years. It is a case-control study, participants (1344 men/women aged 18-60 years) are either patients with known BE (860) or controls individuals' with reflux or indigestion (dyspepsia) symptoms referred for endoscopy (484). All participants swallowed a Cytosponge™ device prior to endoscopy, which is processed for a number of different biomarkers. Results are then compared with endoscopy findings. After the first year of study all cases completed Cytosponge™ and endoscopy procedures. The BEST2 study would like to follow-up participants using HES information in order to collect long-term efficacy and safety data. The main objective is to assess the reproducibility and efficiency of the Cytosponge™ procedure and results to determine the risk of cancer progression, and to compare with endoscopic biopsies, for potential use in the NHS or other health care setting. The Cytosponge™ test showed a specificity of 92% and a sensitivity of around 80% which increases with segment length and is not compromised in the presence of dysplasia. The Cytosponge™-TFF3 test could be used to diagnose patients who would otherwise be referred to endoscopy to rule out BE and therefore be a more systematic screening test for use in primary care. Follow up of all participants is needed to continue monitoring the presence of dysplasia and any risks of cancer progression. Currently guidelines recommend endoscopic screening for BE in individuals with multiple risk factors. However, the cost advantages associated with the Cytosponge™-TFF3 test means screenings could be offered to a larger number, thereby improving the potential to correctly identify a greater amount of newly diagnosed BE cases. The BEST2 study trial site (Cambridge) propose to provide the identifiable data to HSCIC, for all participants that have consented to this, for linkage. HSCIC will return the linked data set with any patient identifiable information (NHS number, names etc) that Cambridge previously sent to the HSCIC along with requested data sets. Identifiable data is requested so that Cambridge can update any new information on the cohort in order to contact participants. Cambridge will not contact the patients directly but will inform the participants GP who in turn will discuss with the participant. Cambridge will then send a patient level pseudonymised version of this data set to QMUL for further processing linked using a unique study ID. Data linkage will improve the quality and integrity of data already collected. All clinical data received, will be stored in a distinctly separate database to the patient identifiable data. The data will not be used for any purpose other than to meet objectives as stated in the trial protocol & will not be shared with any third party organisation. Any information which is used for publication in peer reviewed journals will be anonymised (i.e. aggregated data) & not presented at the individual level.


Project 3 — DARS-NIC-291938-R6V3V

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2017/11.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Processing:

No contact will be made with any individual(s) who could be identified from the information supplied, other than as specified in the protocol and associated documents. Use of the data supplied is for the sole purpose set out above. The Data must not be shared with any other organisation or named individual not explicitly referred to within this agreement. If the information referred to herein is subject to an FOI or other request to share the Data, then agreement from the HSCIC must be sought before undertaking this. The Dataset must not be shared with any third party in the format in which it is provided to you by the HSCIC. Information tools derived from this Dataset will not be provided to any organisations without the specific consent of the HSCIC. Any publications derived from this Data by any party must be subject to ONS confidentiality guidance on the release of birth and death and Health Statistics: The National Statistician sets standards for protecting confidentiality, including a guarantee that no statistics will be produced that are likely to identify an individual unless specifically agreed with them, where the guarantee is judged against the standard that ‘it would take a disproportionate amount of time, effort and expertise for an intruder to identify a statistical unit to others, or to reveal information about that unit which is not already I the public domain.’ Specifically, undertake to ensure that appropriate controls are in place, to ensure compliance with the HSCIC’s, Small Numbers Special Terms and Conditions. Such controls will, as a minimum, meet the requirements of condition 3.3 of the Small Numbers Special Terms and Conditions and more generally satisfy Section 5 of the ONS confidentiality guidance.

Objectives:

The aim of this study is to establish an epidemiologically based sample of all patients with diabetes within the regions included in the Diabetes Research Network (DRN). By collecting the same non-invasive samples as per clinical care it will be possible to perform tests to look for markers of the complications of diabetes. DNA will be taken from all consenting patients and molecular and genetic information will be combined with clinical information to provide a resource to look for gene/environment interaction in the development of Type 1, Type 2 and other forms of diabetes and their associated complications. Data access is restricted to those named in section 7 of this agreement. Any changes will be notified to the HSCIC.


Project 4 — DARS-NIC-324220-P6W9Y

Opt outs honoured: Y

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2018/02.

Repeats: Ongoing, One-Off

Legal basis: Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • MRIS - Flagging Current Status Report
  • MRIS - Cause of Death Report
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Outpatients
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Benefits:

Expected measurable benefits to health and/or social care including target date: 1.1. Primary 1. Following completion of the analysis (duration one year from data received) the customer will be able to publicise the effectiveness of cancer prevention drugs tamoxifen and anastrozole in reducing the occurrence of cancer. 2. To compare any potential or serious side effect from using either tamoxifen or anastrozole for a long period of time 1.2. Secondary 1. To examine the rate of breast cancer recurrence and new contralateral tumors after cessation of tamoxifen or anastrozole. So it can be observed if cancer rates will increase after one has stopped using the medication 2. As the drugs administered in this trial are still widely used it will benefit the public to have a clear understanding if there are any long term issues linked to using the drug and cardiovascular disease, fracture rates and non-cancer deaths. There is considerable interest in the trial from Cancer Research UK who are funding the study the steering committee is co-Chaired by a representative from CRUK. The publication and findings from HSCIC data will be used to inform our studies drug providers the overall impact and effectiveness of their drugs including long-term side effects.

Outputs:

Specific outputs expected, including target date: Data outputs produced will not contain any patient identifiable data or be shared with any third party organisation. The only outputs produced will be publications (medical journals; The Lancet, Breast Cancer research and treatment, British Journal of Cancer) for research purposes using aggregated data or small numbers suppressed derived from our findings at the most. These will be delivered over a 10-year period. The data will not be used for any purpose other than to meet objectives as stated in the trial protocol & will not be shared with any other organisation. Any information which is used for publication in peer reviewed journals will be anonymised & not presented at the individual level .The study estimate that the research will be complete following 9 months after the date that the first dataset received. Any comparisons between findings from other studies or countries will be made the aggregated level and under no circumstances will identifiable data be used for this or in any publications. Only the members of the study will have access to the direct outputs received suppressed in line with HES analysis guide from the HSCIC

Processing:

Processing activities: QMUL will send the IBIS-II cohort data (list of participants on the IBIS-II study) the legal basis for the cohort is Section 251 (Full name, DOB, NHS number) to HSCIC for data linkage. QMUL will use the returned data set to link baseline study findings with potential cancer progression and any occurrence of serious adverse events identified by HES, ONS or cancer registry data. The identifiable data will be used to confirm the strength of each linkage. This ensures that no incorrect diagnoses are made which would invalidate the study. Patient HES/ONS data will be electronically stored on an Oracle database (Oracle 11g). the system is self-contained within the Barts Cancer Centre QMUL network and firewalled off from the rest of the network and external connections. This only allows access for those members mentioned on this applications. No data held from IBIS-I will be used as any part of this study. IBIS-I and IBIS-II are two separate studies run in parallel. QMUL will use the returned data set to link baseline study findings with potential cancer progression and any occurrence of serious adverse events identified by HES, ONS or cancer registry data. Data will be analysed by the study to ascertain how many cancers and/or serious adverse events have occurred since baseline. The applicant will also look at any adverse outcomes such as death in patients who are using anastrozole. This analysis will only make use of the unique study identifier to match each participant to their health record from this stage onwards PID will not be analysed.

Objectives:

Purpose The Data Recipient agrees to process the Data only for the following purposes agreed with the HSCIC: Objective for processing: The International Breast Cancer Intervention Study (IBIS-II) Prevention & DCIS (Ductal Carcinoma In-Situ) studies were designed to continue the work started by IBIS-I in determining whether a chemo preventive strategy towards breast cancer is beneficial. Both are double-blind, placebo controlled, randomised trials, which recruited post-menopausal women between the ages of 40 & 70. It is the intention to collect data for these cohorts regarding breast cancers, including recurrences, through the use of HES and ONS data, in order to assess efficacy, and meet the primary and secondary objectives of the trial. The primary objective is to determine the long-term effect of using anastrozole and assess if it is at least as effective as tamoxifen in local control and prevention of contra-lateral disease in women with locally excised estrogen receptor (ER) or progesterone receptor (PgR) positive cancer tumors. The participants HES/ONS data will be used to compare the effects and effectiveness of the two drugs used in the intervention (tamoxifen and anastrozole). The study will observe the patients data for any cancer occurrences or serious medical illnesses that occurred each year during the study (intervention arm 2000-2010) tracking notable changes in health their status. Secondary objectives of the study are: i. To examine the rate of breast cancer re-occurrence and new contra-lateral tumors after cessation of tamoxifen or anastrozole. ii. To examine the effect of tamoxifen versus anastrozole on breast cancer mortality Data received from the HSCIC will be used to examine the health statuses of each participant following the end of their taking of the drug to present day and ongoing for long-term analysis. Furthermore, long-term use of anastrozole has been linked to increased fracture rates and research has indicated there are risks of cardiovascular events associated with radiotherapy, a treatment which some of the (Ductal carcinoma in situ) DCIS participants may have undergone. This highlights a vital need for passive follow-up to obtain important safety data regarding other cancers, cardiovascular & thromboembolic events, and fractures, from inpatient, outpatient and A&E records. To measure this the applicant will observe the number of fracture, cardiovascular and thrombolic events that occurred throughout the duration of the study period and after in order to build a profile of possible side effects for each drug.


Project 5 — DARS-NIC-55950-Y5Y2Y

Opt outs honoured: Y

Sensitive: Non Sensitive, and Sensitive

When: 2017/06 — 2017/08.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012)

Categories: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Office for National Statistics Mortality Data

Benefits:

NELA has become a successful audit and is already tracking some improvements in patient outcomes nationally. However feedback from hospitals is that it can be difficult for them to know what changes to make that are most likely to lead to sustained improved outcomes for patients, or how best to bring about these improvements. EPOCH is built around a trial of a systematic and specific improvement intervention: a quality improvement programme. We have undertaken and will publish a great deal of evaluation of the quality improvement programme itself (both the ethnography and also through a process evaluation of the trial). Access to HES and ONS data is essential so that we can analyse and report the impact of the improvement intervention in terms of quality of care and patient outcome. Once we know the outcomes of the trial, we will be able to deduce evidence-based recommendations about what works and what does not work in improving care for this patient group, thereby allowing frontline clinicians and managers to make informed decisions about how best to improve patient care. Further to this, we will gain an understanding of quality improvement as a process in the NHS (in terms of feasibility and impact) which will be informative for commissioners and policymakers. Due to the synergy between EPOCH and NELA, with the latter providing an ongoing data set to support quality improvement, we could expect to begin to see this accelerated improvement commence within months of publication of the trial results. This is because hospitals will be able to track their improvements through ongoing participation in NELA. Publications will allow widespread dissemination of the findings amongst health professionals. 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. Through dissemination in publications and at meetings (please see ‘Outputs’) results about did and didn’t work in the clinical care pathway will reach frontline clinicians (surgeons, anaesthetists and intensive care doctors). Therefore, we would expect to see measurable benefits, for emergency laparotomy patients nationwide, within 6-12 months of publication. We believe this work will influence trigger a sustained and widespread peri-operative quality improvement for all high-risk patients over a much longer period, with sustained and measurable benefits seen over a 2-10 year period from publication. A further measurable benefit is the anticipated contribution of the outputs produced as a result of the trial to clinical guidance and national policy within a 1-2 year period from publication.

Outputs:

The following outputs are planned: Final Report to Funder - 30th May 2017 Final EPOCH Investigators Meeting - summer 2017 Peer Reviewed Publications - summer 2017 Conferences and meetings - 2017 - ongoing Media – 2017 – ongoing NELA Website - 2017 Details of expected outputs: The main scientific report containing only aggregated data with small numbers supressed in line with the HES analysis guide will be sent to the Lancet journal for their consideration first. The Lancet have already published the trial protocol, and have expressed an interest in the work. Second choices would include the British Medical Journal, the New England Journal of Medicine, and the Journal of the American Medical Association. These are all general interest journals read by a wide range of healthcare workers worldwide. QMUL plan to invite all the co-investigators (from 92 hospitals) to a final EPOCH meeting where we will disseminate and discuss the findings. QMUL will also present the work at scientific meetings, and congresses. For example the ‘Annual Congress of Enhanced Recovery and Perioperative Medicine’ and the ‘Peri-Operative Medicine Congress’. QMUL will also disseminate the aggregated findings through the mainstream media (e.g. BBC news, Channel 4 News, Times Newspaper etc.) and also through social media (e.g. Twitter) with the support of our patient representatives. The main target audience will be surgeons, anaesthetists and intensive care doctors but also patients and their carers. The findings will also be published on the NELA and EPOCH websites. All outputs will aggregated with small numbers supressed in line with the HES analysis guide.

Processing:

The processing will follow these steps: Step 1 - RCS flow NHS number to NHS Digital, NHS Digital flow HES + ONS data to RCS with Objections upheld, this step has been completed under the agreement NIC-355855 and the flow is covered by s251 of the Care Act 2006. Step 2 - QMUL apply to NHS Digital for HES + ONS data (this application). The legal basis for the HES APC data is The Health and Social Care Act 2012 and the legal basis for the ONS data is s42(4) of the SRSA 2007. Step 3 - NHS Digital confirm to HQIP that QMUL have approval for the release HES + ONS data, once the application has been recommended for approval by DAAG Step 4 - RCS flow HES ID + study ID to NHS Digital to define cohort Step 5 - NHS Digital send study ID’s to RCS with objections upheld if relevant (copy in HQIP) Step 6 - QMUL apply separately to HQIP for audit data Step 7 - NHS Digital flow HES + ONS data to QMUL, (with study ID) with objections upheld if relevant Step 8 - HQIP authorise RCS to flow the audit data to QMUL Step 9 - RCS flow authorised audit data to QMUL Step 10 - QMUL will perform linkage of HES/ONS and Audit data based on a study id Step 11 - QMUL will perform linkage of HES/ONS and Audit data with Heath Economic sub-study data based on a study id The only identifiable field received by the EPOCH team is ONS Date of Death. The full Date of Death is required to be able to calculate survival at 2 time points (90 day, 180 day). The EPOCH team will not use ONS Date of Death to identify any individual patients. To be clear no attempt will be made at any point to re-identify and individual. In line with good practice, QMUL retains raw data to enable responses to journal peer reviews and re-analysis if required. Therefore Date of Death and Cause of Death will be retained for a 2 year period before being destroyed. In line with QMUL procedure, all other data will be archived for 20 years. The data received from HSCIC will not be linked back to the identifiable NELA database. An extract of annonymised NELA data will be linked to the HES-ONS data via the NELA ID. The annoymised NELA data and the HES-ONS data will also be linked to a Health Economics (HE) dataset via the NELA ID. The HE dataset does not contain any identifiers. Each patient in the Health Economics (HE) dataset also exists in the NELA dataset, and their NELA ID has been recorded in both datasets. The data has been collected as part of an ethically approved sub-study for the EPOCH trial, using patient consent. The EPOCH team Statisticians and Health Economists who will work on the linked dataset do not have access to the identifiable data set held by the RoCA or any identifiers held locally at hospitals. Only Queen Mary University Staff will have access to the data. The EPOCH team at QMUL will analyse the data in a secure environment with restricted access (called a safe haven) to assess the objectives listed. Outputs from the EPOCH analysis will only include aggregated data, no individual level data will ever leave the safe haven where the analysis is taking place .

Objectives:

More than 150,000 high-risk patients undergo emergency surgery each year in the NHS, following which at least 90,000 patients develop complications resulting in over 20,000 deaths before hospital discharge. Patients who develop complications but survive, require in-hospital care for prolonged periods, suffering substantial reductions in functional independence and long-term survival. Recent data show that abdominal surgery and the need for surgery on an emergency basis are amongst the strongest factors associated with poor post-operative outcome. Around 35,000 patients present to NHS hospitals each year with precisely this pattern of risk and undergo a procedure known as ‘emergency laparotomy’. This term describes a major surgical procedure to treat an acute and often life threatening problem with the gut or other abdominal organ. Around 180 patients undergo emergency laparotomy in a typical NHS hospital each year with a 90-day mortality of 25%. There is considerable heterogeneity in standards of care between hospitals, including wide variations in the involvement of senior surgeons and anaesthetists and post-operative admission to critical care, which are associated with important differences in mortality rates. In 2010 the Department of Health commissioned a Royal College of Surgeons of England (RCS) working group to develop an integrated care pathway which could improve the quality of care for patients undergoing emergency laparotomy. An integrated care pathway was defined which represented an optimal standard of peri-operative care deliverable in all NHS hospitals. Examples of interventions included consultant led decision making and treatment, standards for diagnostic testing, structured post-operative surveillance, time limits for review of deteriorating patients and early admission to critical care. To date, there has been little systematic implementation of any component of the integrated care pathway. Most opinion leaders agree there is an urgent need for a national project to improve survival for emergency laparotomy patients. However, there is uncertainty about how best to achieve such improvement. Some question the benefits of quality improvement initiatives, pointing to the lack of robust clinical evidence of effectiveness, both in terms of generic methodologies advocated to improve quality, and the specific changes in patient care. There are examples where a discrete quality improvement intervention was associated with improved clinical outcomes. And experience from recent quality improvement initiatives has shown that challenges with quality improvement programmes can be overcome. However, doubts over the clinical effectiveness of quality improvement projects continue to limit the success of these initiatives. There is a clear need for robust clinical evidence to support or refute the use of this approach to improve clinical practice and, ultimately, patient outcome. The Healthcare Quality Improvement Partnership (HQIP) has commissioned a new National Emergency Laparotomy Audit (NELA), providing a unique opportunity to study the clinical effectiveness of a quality improvement project to implement an integrated peri-operative care pathway for emergency laparotomy patients. By providing a robust evidence base for quality improvement in peri-operative care, the findings of this work could accelerate implementation of care pathways for all categories of high-risk surgery with the potential for widespread improvements in survival affecting more than 170,000 NHS patients each year. QMUL have conducted a large pragmatic clinical trial of the effectiveness of a quality improvement project to implement a modified version of the RCS integrated care pathway to improve patient outcomes following emergency laparotomy. The trial is called Enhanced Peri-Operative Care for High-risk patients (EPOCH). Our aim is to provide the definitive evidence needed to inform practice in this area. TRIAL OBJECTIVES: 1. To evaluate the effect of a quality improvement intervention to promote the implementation of an integrated peri-operative care pathway on survival at 90 days following emergency laparotomy. 2. To assess the cost-effectiveness of the quality improvement intervention compared to ongoing clinical practice without the intervention. 3. To evaluate the long-term effects of the intervention on standards of care and mortality following emergency laparotomy in participating hospitals. Primary outcome measures: All cause mortality at 90 days following surgery Secondary outcome measures: All cause mortality at 180 days following surgery, duration of hospital stay and hospital re-admission within 180 days of surgery. In eight hospitals EQ-5D 3L will be collected and healthcare resource use data preoperatively, and at 90 and 180 days after surgery to perform a health economics analysis. In eight hospitals a Health Economics sub-study has been conducted. This involved patients who are already part of the NELA audit. QMUL consented patients and collected information (at 30, 90 and 180 days after surgery) about their quality of life and healthcare use using standardised questionnaires. The information that was recorded on paper questionnaires was entered into a secure, password protected database hosted by Queen Mary University London. No identifiable information was recorded in the database. Each patient in the Health Economics sub-study has a NELA ID which will be used to link with the main NELA dataset and data from ONS and HES. The team will collect EQ-5D 3L (a standardized questionnaire for measuring generic health status and quality of life) and healthcare resource use data preoperatively, and at 90 and 180 days after surgery to perform a health economics analysis which aims to assess whether implementing the quality improvement intervention is likely to be cost-effective on average and whether this varies between low and high mortality groups. As a national clinical audit funded by the Healthcare Quality Improvement Partnership (HQIP), the National Emergency Laparotomy Audit (NELA) has been established with the fundamental aim of improving the quality of patient care, and clinical outcomes. The EPOCH trial is an important example of how the data collected by NELA can be used to drive improvements in patient care.