Enhanced Peri-Operative Care for High-risk patients (EPOCH) Trial - Data Linking Request

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Queen Mary University London to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

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, to which this agreement relates. The trial is called Enhanced Peri-Operative Care for High-risk patients (EPOCH). QMUL 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.

This Agreement permits the secure retention of the data only and no other processing.

No new outputs will be produced under this Data Sharing Agreement.

The following outputs were previously planned/executed:

Final Report to Funder - May 2019

Final EPOCH Investigators Meeting - spring 2019

Peer Reviewed Publications - Spring 2019 - Spring 2021

Conferences and meetings - 2019 - ongoing

Media – 2019 – ongoing

NELA Website - 2019

Details of expected outputs:

Although the final report was sent to the funder in May 2019 QMUL are still processing and analysing the data to produce further papers.

The main scientific report containing only aggregated data with small numbers supressed in line with the HES analysis guide was sent to the Lancet journal for their consideration. The Lancet published the paper in April 2019. The Lancet have also published the trial protocol.

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 QMUL 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.

In any subsequent application to extend this Data Sharing Agreement, Queen Mary University London will be required to provide details of any benefits to patients and/or to the wider healthcare system arising from the outputs produced using the data since 2017.

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, to which this agreement relates. The trial is called Enhanced Peri-Operative Care for High-risk patients (EPOCH). QMUL 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.

The following outputs are planned:

Final Report to Funder - 15th August 2018

Final EPOCH Investigators Meeting - summer 2018

Peer Reviewed Publications - Autumn 2018

Conferences and meetings - 2018 - ongoing

Media – 2018 – ongoing

NELA Website - 2018

Details of expected outputs:

Although the final report will be sent to the funder on 15 August 2018 QMUL will process and analysis the data to produce further papers.

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 QMUL 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 QMUL 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.

As data analysis is ongoing, yielded benefits cannot yet be articulated.