NHS Digital Data Release Register - reformatted

Queen Mary University of London

Opt outs honoured: Y

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

Format: Identifiable Sensitive

How often: Ongoing

When: unknown — 11/2016

HSCIC Id: DARS-NIC-147843-8NKTW-v0.0

Data: MRIS - Cause of Death Report

Data: MRIS - Cause of Death Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Scottish NHS / Registration

Data: MRIS - Flagging Current Status Report

Data: MRIS - Flagging Current Status Report

Data: Hospital Episode Statistics Admitted Patient Care

Data: Hospital Episode Statistics Accident and Emergency

Data: Hospital Episode Statistics Outpatients

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Cause of Death Report

Data: Hospital Episode Statistics Admitted Patient Care

Data: Hospital Episode Statistics Accident and Emergency

Data: Hospital Episode Statistics Outpatients

Data: Hospital Episode Statistics Admitted Patient Care

Data: Office for National Statistics Mortality Data

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Scottish NHS / Registration

Output: 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.

Activities: 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 .

Objective: 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.

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.

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.

Source: NHS Digital.