The BCAE Study: Best Care for Abdominal Emergencies
Conditions: Acute Abdomen, Bowel Obstruction, Bowel; Ischemic, Acute, Bowel Perforated, Peritonitis
Sponsor: Portsmouth Hospitals NHS Trust

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 1 of 24 
 
 
 
 
Study Title:  The BCAE Study: Best Care for Abdominal Emergencies 
Internal Reference No: PHT/2019/72 
IRAS ID: 282238 
Date and Version No: 2020-Sep- v0.1              
Chief Investigator: 
Dr Simon Khay Chuan Toh, Consultant Surgeon,  Portsmouth 
Hospitals University NHS Trust,  
simon.toh@porthosp.nhs.uk, +44 2392286885 
Investigators:  
Jim Briggs, Professor, University of Portsmouth 
David Prytherch, Professor, University of Portsmouth 
Ina Kostakis, Research Fellow, University of Portsmouth 
Paul Meredith, Data Manager/Analyst, Portsmouth Hospitals 
University NHS Trust, Research & Innovation 
Alexander Darbyshire, Research Registrar, Portsmouth Hospitals 
University NHS Trust 
Anna Glanville-Hearson, PPI representative 
 
Sponsor:  
Portsmouth Hospitals University NHS Trust  
Funder (if applicable): 
NIHR, Programme Research for Patient Benefit: £150,000 
University of Portsmouth: In kind contribution of difference between 
full economic cost and grant 
NIHR Reference:  
201558 
REC Reference: 
20/SC/0380 
IRAS Reference: 
282238 
ClinicalTrials.gov 
Identifier: 
NCT………. 
Signatures:  
TohKhayChuan   Date: 24/09/2020 
Mr.Simon K C Toh, Consultant Surgeon 
Portsmouth Hospitals University NHS Trust, Cosham PO6 3LY, UK 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 2 of 24 
 
 
 
 
 
  
Protocol Development Team:   
Simon Khay Chuan Toh, Consultant Surgeon, Portsmouth Hospitals University NHS Trust 
Jim Briggs, Professor, University of Portsmouth 
David Prytherch, Professor, University of Portsmouth 
Ina Kostakis PhD, Research Fellow, University of Portsmouth 
Paul Meredith, Data Manager/Analyst, Portsmouth Technology Trials Unit, Portsmouth 
Hospitals University NHS Trust 
Alexander Darbyshire, Research Registrar, Portsmouth Hospitals University NHS Trust 
Anna Glanville-Hearson, PPI representative (Service user/lay member) 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 3 of 24 
 
 
 
TABLE OF CONTENTS 
 
1. 
AMENDMENT HISTORY ................................................................................................ 5 
2. 
SYNOPSIS ..................................................................................................................... 6 
3. 
ABBREVIATIONS ........................................................................................................... 8 
4. 
BACKGROUND AND RATIONALE ................................................................................. 9 
4.1 
What is the problem being addressed? .................................................................... 9 
4.2 
Why is this important? .............................................................................................. 9 
4.3 
Why is this research needed now (existing evidence)? .......................................... 10 
4.4 
Impact of research ................................................................................................. 11 
5. 
PRELIMINARY STUDIES AND EXPERIENCE OF INVESTIGATORS .......................... 11 
6. 
AIMS AND OBJECTIVES ............................................................................................. 12 
6.1 
Aim ........................................................................................................................ 12 
6.2 
Objectives .............................................................................................................. 12 
7. 
STUDY DESIGN ........................................................................................................... 13 
7.1 
Summary of Study Design ..................................................................................... 13 
7.2 
Primary and Secondary Endpoints/Outcome Measures ......................................... 13 
7.3 
Study Setting ......................................................................................................... 13 
7.4 
Study Participants ..................................................... Error! Bookmark not defined. 
8. 
SAMPLE SIZE .............................................................................................................. 14 
9. 
DATA HANDLING AND RECORD KEEPING ............................................................... 15 
9.1 
Data collection and extraction ................................................................................ 15 
9.2 
Data Management ................................................................................................. 15 
10. 
DATA ANALYSIS ...................................................................................................... 15 
10.1 
Data set ................................................................................................................. 15 
10.2 
Data analysis ......................................................................................................... 15 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 4 of 24 
 
 
 
11. 
ETHICS ..................................................................................................................... 16 
11.1 
Declaration of Helsinki ........................................................................................... 16 
11.2 
ICH Guidelines for Good Clinical Practice .............................................................. 16 
11.3 
Other Ethical Considerations ................................................................................. 17 
11.4 
15.1 Participant Confidentiality .................................. Error! Bookmark not defined. 
12. 
PATIENT PUBLIC INVOLVEMENT (PPI) .................................................................. 18 
12.1 
Study design .......................................................................................................... 18 
12.2 
Study implementation ............................................................................................ 18 
12.3 
Dissemination ........................................................................................................ 18 
13. 
FINANCING AND INSURANCE ................................................................................ 19 
13.1 
Research Costs ........................................................ Error! Bookmark not defined. 
13.2 
Service Support Costs .............................................. Error! Bookmark not defined. 
13.3 
Excess Treatment Costs ........................................... Error! Bookmark not defined. 
13.4 
Study Sponsorship .................................................... Error! Bookmark not defined. 
14. 
TIMETABLE AND ORGANISATIONAL CHART ........................................................ 20 
15. 
DISSEMINATION AND OUTCOME ........................................................................... 22 
15.1 
Outputs .................................................................................................................. 22 
15.2 
Dissemination ........................................................................................................ 22 
15.3 
Next steps .............................................................................................................. 22 
16. 
REFERENCES .......................................................................................................... 22 
 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 5 of 24 
 
 
 
1. 
AMENDMENT HISTORY 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes 
made 
 
 
 
 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 6 of 24 
 
 
 
2. 
SYNOPSIS 
It may be useful to include a synopsis of the study for quick reference.  Delete or alter as 
appropriate/required. 
Study Title 
The BCAE Study: Best Care for Abdominal Emergencies 
Internal ref. no. 
PHT/2019/72 
Problem statement 
Abdominal emergencies are common, involving perforation, obstruction or 
ischaemia of the bowel, often needing life-saving emergency surgery, with a 
large incision to access the abdominal cavity called “laparotomy”. This 
procedure is high risk with 10% mortality rate. 30,000 emergency laparotomies 
are performed each year in England and Wales. Since 2013, the National 
Emergency Laparotomy Audit (NELA) has set standards of care and monitored 
outcomes for emergency laparotomy, which has reduced mortality from 11.8 to 
9.5%. However, patients who do NOT have a laparotomy are not well 
characterised and do not receive the prioritised care patients having surgery 
do, even though their condition is no less severe. Initial research has shown a 
surprisingly large group of patients (32%) with an intestinal emergency do not 
have surgery and have 30-day mortality of 63%. There are two additional 
groups of patients admitted with abdominal emergencies: patients having 
keyhole surgery and patients for whom any treatment would be futile and would 
benefit most from an end of life care pathway. Clearly further work is needed to 
investigate the management of ALL patients with intestinal emergency, to 
optimise care for each group of patients. 
Research question / 
hypothesis 
The aim of this study is to improve care for all patients with an intestinal 
emergency, irrespective of whether they have surgery or not.  
Study Design 
This is a single-centre retrospective cohort study utilising electronic hospital 
records. 
Study Participants 
Data will be derived from electronic patient records collected as part of routine 
clinical patient care on all general adult wards (excluding maternity) between 
2013 and 2020. 
 
Inclusion criteria: 
• 
Must have an acute intestinal condition, based on their ICD-10 codes 
and OPSC-4 codes 
• 
Must be >= 16 years of age at the time of admission 
• 
Have at least one full set of vital signs recorded on the day of 
admission 
• 
Have at least one full set of routine blood tests recorded on the day of 
admission 
Exclusion criteria: 
• 
Maternity admissions during/after pregnancy 
• 
Patients admitted or undergoing abdominal surgery for a second time 
or more 
Using OPCS-4 codes from PAS and TheatreManTM  and NELA data, we will 
then identify patients who had an emergency laparotomy, and those who had a 
laparoscopic procedure. We aim to identify a further group where treatment is 
futile, suggesting that an early focus on end of life care might be appropriate. 
Planned Sample Size 
2,500 
Follow-up duration 
1 year (retrospectively) 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 7 of 24 
 
 
 
Planned Study 
Period 
01 Dec 2020 – 31 May 2021 
Primary Objective 
Provide mortality rates for different treatment options, and analysis of short- 
and long-term outcomes. 
 
Secondary 
Objectives 
Define patient sub-groups with similar health characteristics based on clinical 
data and an established risk index. 
 
Use statistical analysis to predict the risk of death for each patient group and 
treatment option, which will allow us to identify the best care pathways for each 
cluster. 
Primary Endpoint 
Mortality risk for each treatment group 
Secondary 
Endpoints 
Risk of other outcomes and long-term complications and association between 
patient factors and these outcomes 
Intervention (s) 
N/A 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 8 of 24 
 
 
 
3. 
ABBREVIATIONS 
AUROC 
Area Under the receiver operating 
characteristic curve 
EWS 
Early warning score 
ICD-10 
International Classification of Diseases, 
version 10 
GDPR 
General Data Protection Regulation 
LDTEWS 
Laboratory decision tree early warning score 
NELA 
National Emergency laparotomy audit 
NEWS 
National early warning score 
NHS 
National Health Service 
OPCS-4 
Office of Population Censuses and Surveys, 
Classification of Surgical Operations and 
Procedures (4th revision) 
PAS 
Patient Access system 
PHUT 
Portsmouth Hospitals University Trust 
P-POSSUM 
Portsmouth Physiological and Operative 
Severity Score for the enUmeration of 
Mortality and morbidity 
PRA 
Patient Research Ambassador 
QI 
Quality improvement 
UoP 
University of Portsmouth 
ViEWS 
VitalPac Early warning score 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 9 of 24 
 
 
 
4. 
BACKGROUND AND RATIONALE 
4.1 
 What is the problem being addressed? 
30,000 emergency abdominal laparotomies are performed each year in England and Wales (1). Each 
involves making a large incision down the middle of the abdomen to gain access to the abdominal 
cavity. In 2011, the Royal College of Surgeons England issued a report highlighting concerns that the 
mortality rate for patients having laparotomy was about twice that of open-heart surgery, with a 
number of shortfalls in patient care contributing to this (2, 3). Since 2013, the National Emergency 
Laparotomy Audit (NELA) has monitored outcomes from emergency laparotomy across the UK. The 
audit sets standards of care against which hospitals are benchmarked, such as early administration of 
antibiotics, CT-scan for diagnosis, pre-operative risk assessment, consultant surgeon/anaesthetist 
presence in theatre and transfer to intensive care postoperatively, leading to better outcomes 
(1, 4-6). 
 
Conversely, patients with intestinal emergencies who do NOT have a laparotomy are not well 
characterised and do not receive the prioritised care that patients having surgery do; even though their 
condition is no less severe. There is a significant lack of information on the outcome and quality of life 
of patients who do not have a laparotomy. In the UK, only a single small study, the NoLap Study (7), 
has looked at this. They found a 30-day mortality of 63% in these patients compared to 13% for those 
who had a laparotomy. It is this surprisingly large group of patients (32%), who have such a poor 
outcome that deserves further investigation.  
 
This study will benefit patients by providing information on the outcomes for ALL patients admitted 
with an intestinal emergency. Effective alternatives to laparotomy exist, including keyhole 
(laparoscopic) surgery (8-12) and interventional radiology procedures (13-16). These are less invasive 
and could carry lower risks than a laparotomy. By identifying groups of patients for whom these less 
invasive procedures may be more appropriate, the development of new alternative care pathways for 
them can be prioritised. There will sadly be some patients for whom active treatment is futile, such as 
those with loss of blood supply to the bowel or advanced cancer (17). Defining this patient group too 
will facilitate the development of pathways that have an earlier focus on symptomatic best end of life 
care. The characteristics of patients and their outcomes undergoing all the above 4 options will be 
investigated. Knowing these risks will help us better inform patients of the likely outcomes of their 
choices.  
4.2 
 Why is this important? 
Patients who do have a laparotomy are high risk, with a 10% mortality rate at 30 days measured 
nationally. This group is closely scrutinised by the National Emergency Laparotomy Audit (NELA) who 
set strict standards of care, and outcomes from surgery are well characterised (1, 2, 4-6). However, 
there is clear evidence that patients with intestinal emergencies who do NOT have emergency 
abdominal surgery (laparotomy) do very poorly, with only 30% of patients surviving to a year from 
admission (7). Our concern is that patients not undergoing laparotomy, but with the same life-
threatening pathology, are being forgotten and do not receive the focus of care that they deserve. To 
improve the quality of care for these patients, better understand the risk of mortality and associated 
patient factors for ALL patients admitted with an intestinal emergency is needed. 
 
This much-needed study will benefit patients by providing information on the 30-day and 1-year 
mortality for all patients with an intestinal emergency admitted to our hospital over a 6.5-year period. 
By observing relationships between mortality and patient factors like age, diagnosis, co-morbidities, 
vital signs, blood tests and surgery versus no-surgery, factors influencing patient outcomes will be 
identified and better understood. The "NoLap" study (7) suggested that a cohort of these patients who 
didn’t have a laparotomy might in retrospect have had a better chance of survival if they had. To 
investigate this, patient factors will be analysed and patterns that significantly influence mortality will 
be determined. Results will provide insights into the different patient groups and improve our 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 10 of 24 
 
 
 
understanding of their risk of death, with or without surgery. This will enable clinicians to more 
intelligently advise patients and their relatives on risks of laparotomy against alternative management. 
 
The NoLap study does not provide information on the performance of laparoscopic (keyhole) 
procedures compared to laparotomies for abdominal emergencies. PHUT has championed the use of 
laparoscopy in emergency surgery, with progressive uptake by all consultants from 2014 onwards 
(11). By 2018, 60% of cases were completed laparoscopically, far higher than the national average of 
8% (1). More importantly, this approach has been shown to be safe, with reduced mortality and length 
of stay (11). For patients unfit or unable to have any surgery, the Department of Interventional 
Radiology provides an on-call service to drain sepsis and embolise bleeds under local anaesthesia. In 
this study, information on the outcomes for patients who had an intestinal emergency managed 
laparoscopically or had an interventional radiology procedure will be collected. The effect of alternative 
treatments on patient outcomes will be assessed to determine which patient groups would most likely 
benefit from these interventions. This will benefit patients by providing clinicians with the scientific 
knowledge needed to develop better care pathways using these less invasive procedures. This will 
provide clinicians and their patients with the evidence they need to make a better-informed choice 
between laparotomy, minimally invasive procedures and symptomatic end of life care. 
4.3 
 Why is this research needed now (existing evidence)? 
Emergency laparotomy remains a common, high-risk operation (1). It is mostly performed for 
emergencies where there is perforation, obstruction or ischaemia of the bowel (intestine) that could 
lead to peritonitis. These are time critical pathologies requiring urgent treatment and careful peri-
operative care, with a poor chance of survival without surgery (2-3). Since 2013, the National 
Emergency Laparotomy Audit (NELA) has monitored outcomes from emergency laparotomy across 
the UK, with a strong focus on identifying high-risk patients, ensuring consultant-led care and 
admission to intensive care postoperatively to improve outcomes (1, 4-6). 
 
However, very little research has investigated the outcomes and the care received by patients with 
intestinal emergencies who do not have a laparotomy. The NoLap study (7) collected data on 314 
patients admitted with an intestinal emergency and found a substantial patient group (32%) who do 
not have surgery. Of these, 74% were not felt to be fit enough for laparotomy, 6% had advanced 
cancer, 4% declined surgery and 16% undocumented. The 30-day mortality rate for patients with 
laparotomy was 13%, in-line with expected outcomes, yet the rate for patients who did not have 
surgery was 63%. This group were older (78 vs 63.7 years old) and frailer (30% vs 81%) and more 
likely to have co-morbidities. This study will build on this information to provide clear answers about 
which patient groups could benefit from laparotomy or alternative, less-invasive treatments. Factors 
significantly influencing mortality will be identified for clinicians to better inform patients/relatives of 
risks of their treatment. The NoLap study also compared two surgical risk models (18-19) to 
benchmark outcomes (7). Observed mortality (13%) in the laparotomy group closely matched the 
predicted mortalities (12% and 17%).  
 
However, predicted mortality for the patients who did not have surgery was much lower (30% and 
40%) than the actual observed mortality (63%). This suggests that some patients who were perceived 
as not fit enough for surgery actually had a better chance of survival with a laparotomy. This highlights 
the need to better understand why patients with intestinal emergencies do/do not have a laparotomy: 
why are patients not receiving the best possible care and so missing potentially life-saving treatment? 
The discrepancy could be due to unmeasured confounding patient factors that are not included in the 
risk model. Our study will identify the factors that influence mortality, enabling clinicians to select the 
best care pathway for individual patients and benefit those who may have been advised against 
surgery in the past, but for whom surgery (possibly using a laparoscopic approach) may indeed be the 
best way forward. 
 
NELA standards of care have reduced 30-day mortality in emergency laparotomy from 11.8% to 9.5% 
since 2013(1, 4-6). However, the NoLap study (7) indicated these standards of care were less 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 11 of 24 
 
 
 
frequently achieved in patients who did not have surgery. Decisions not to operate were less often 
informed by a CT scan (67% vs 82%), risk assessed (24% vs 37%), or involved documented 
consultant decision (66% vs 83%). There are possibly other factors that have influenced the decision 
not to operate, such as severe health problems precluding anaesthetic. Nevertheless, this highlights 
concerns that patients not having laparotomy are less likely to receive the same high standards of 
care. This study therefore seeks to redress this by focusing on all patients with abdominal 
emergencies, not just those who have had a laparotomy, to also improve the outcome of this 
neglected group of patients. 
4.4 
 Impact of research 
This study will provide new information on the outcomes for ALL patients with abdominal emergencies 
and the treatment they receive. By identifying groups of patients for whom less invasive procedures or 
end of life care may be more appropriate, it will support the development of new alternative care 
pathways.  
 
This study will contribute novel information on the outcomes of minimally invasive procedures in 
abdominal emergencies (laparoscopy and interventional radiology). This information will be highly 
relevant to acute hospitals providing an emergency general surgery service across the UK. Initial 
analysis of the national NELA database has shown that currently only 8% of surgeries for abdominal 
emergencies in the UK are performed laparoscopically. Early data from Portsmouth Hospitals NHS 
Trust suggests patients may do better with this approach. The findings from this study will provide the 
necessary evidence to increase the proportion of laparoscopies nationwide and, thus, potentially 
significantly reduce risk for patients with abdominal emergencies. 
 
5. 
PRELIMINARY STUDIES AND EXPERIENCE OF INVESTIGATORS 
This study is a continuation of a long-standing collaboration between the University of Portsmouth 
(UoP) and Portsmouth Hospitals NHS Trust (PHU). The team has 20 years of experience in extracting 
and linking these types of data sets for work in clinical outcome modelling and risk prediction. 
 
Our work has previously led to the development of VitalPAC, P-POSSUM (Portsmouth Physiological 
and Operative Severity Score for the enUmeration of Mortality and morbidity) (18) and ViEWS. NEWS 
was a minor modification of ViEWS and its latest version (NEWS2) is now mandated for use in NHS 
hospitals and ambulance trusts (37,22). P-POSSUM, although initially developed as an audit tool, was 
recommended for use by the Royal College of Surgeons in 2011 as pre-operative risk prediction tool 
(2)  They quote:- “P-POSSUM, freely available on the internet, is possibly the simplest and best-
validated method” and: “The POSSUM score is the most validated risk prediction method for general 
and vascular patients that takes into account pre-operative and peri-operative factors. P-POSSUM 
may be used for all patients. A predicted mortality risk ≥10% indicates a need for critical care 
admission, except for patients on end-of-life pathways with appropriate palliative care facilities 
available at ward level.” 
 
Importantly, this team has a track record and ongoing studies of the outcomes of major abdominal 
surgery and less-invasive approaches, as evidenced by these 2 recent publications in peer reviewed 
journal: 
 
• 
Pucher PH, Carter NC, Knight BC, Toh S, Tucker V, Mercer SJ. Impact of laparoscopic 
approach in emergency major abdominal surgery: single-centre analysis of 748 consecutive 
cases. Ann R Coll Surg Engl. 2018;100(4):279-284. doi:10.1308/rcsann.2017.0229 
• 
Darbyshire AR, Kostakis I, Pucher PH, Toh SKC, Mercer S. The impact of laparoscopy on 
emergency surgery for adhesional small bowel obstruction: prospective single centre cohort 
study. . Ann R Coll Surg Engl. 2020. Accepted for publication. 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 12 of 24 
 
 
 
 
Simon Toh is a Consultant Surgeon at PHU and Hon Senior Lecturer at UoP. He has been site 
principal investigator in multiple clinical trials over his career, most recently for the NIHR Studies 
GAPS-2 (38) and FrOGS Frailty and Sarcopenia Outcomes in Emergency General Surgery (39), and 
currently ROSSINI-2 and MASH Studies. He is the Chief Investigator of the Dynamic RCT (40). He 
has been joint lead in PHU for the past 6 years to implement and achieve the NELA Best Practice 
Tariffs. 
 
Alexander Darbyshire is a registrar in general surgery undertaking a research fellowship at PHU and 
completing an MD Res at UoP. His MD is investigating innovative ways of using clinical and 
biochemical data to improve risk modelling for emergency laparotomy, supervised by Briggs and 
Prytherch. He is the study co-ordinator and PI for the NIHR feasibility study “PLUG” at PHU, and 
associate PI for ROSSINI 2 trial at PHU. He has a keen interest in patient safety and improving 
outcomes for patients who may need surgery. His role will include responsibility for the application for 
ethical review, assistance with the data analysis and in the dissemination of findings.  
 
Jim Briggs has extensive research management experience having led or co-led over 30 externally 
funded projects. His expertise is in health informatics, particularly the collection, processing, and 
analysis of data for operational and research purposes. He is currently Chief Investigator for the multi-
site Frequency of Observations (FOBS) project funded by NIHR HS&DR. 
 
David Prytherch is also a health informatician with a long record of publication in clinical outcome 
modelling. He was the key contributor to the development of the widely adopted standard predictor of 
surgical risk, P-POSSUM. He was also instrumental in developing ViEWS (22), the basis of the 
National Early Warning Score (NEWS) published by the Royal College of Physicians and now 
mandated for use in NHS hospitals and ambulance trusts. 
 
Paul Meredith has a doctorate in databases and more than 25 years of experience extracting, 
integrating and analysing healthcare data. He is also a member of the Royal Statistical Society. He is 
currently an investigator in two other NIHR funded projects and has contributed to more than a dozen 
peer-reviewed publications in the last three years. He is based in the research and innovation 
department of PHU and will oversee and coordinate data extraction. 
 
Anna Glanville-Hearson is our PPI representative and is an integral part of the team. She is the sister 
of a patient who died after an abdominal emergency. Anna is a volunteer in the PHU Emergency 
Department and often sees the beginning of the patient journey for people with an abdominal 
emergency. She has been an active member of the PHU Patient Research Ambassador Group for 
several years and is also a volunteer on the PHU Research & Innovation Steering Group. Anna has 
contributed throughout the development of this project, the preparation of the application. She will 
regularly attend project progress meetings and be heavily involved in dissemination activities. 
6. 
AIMS AND OBJECTIVES 
6.1 
Aim 
The overall aim of this study is to improve the quality of care for patients with an abdominal 
emergency, irrespective of whether they have a laparotomy or not. The evidence gathered will provide 
new estimates of the average risk of death for different treatment options and inform the development 
of care pathways. In addition to guiding clinical decisions, our findings will make more robust the 
communication with patients and relatives around different treatment options. 
6.2 
Objectives 
1. Identify all patients with a condition that would qualify them for emergency abdominal surgery, 
both laparotomy and keyhole (laparoscopic) procedures, regardless of whether they had surgery 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 13 of 24 
 
 
 
or not. This will be done by filtering electronic hospital records for appropriate diagnosis and 
operation codes. 
2. Provide updated estimates of the average risk of death for different treatment options, including 
surgical and non-surgical intervention, using statistical analysis of short-term and long-term 
outcomes. Describe health characteristics of the typical patient population receiving one of the 
treatment options, based on their clinical data and an established risk index. 
3. Logistic regression will be used to predict the risk of death for each patient group and each 
treatment option, which will allow identification of the best care pathways given a patient's health 
characteristics. 
4. Identify patients who would have likely benefited from a different care pathway than the one they 
received, using machine learning classification algorithms 
 
Our analysis will form the foundation for the establishment of four well-defined care pathway options, 
each with the patient’s best interest in mind: laparotomy, laparoscopy, other alternative treatment, and 
end of life care. 
 
7. 
STUDY DESIGN 
7.1 
Summary of Study Design 
This single-centre retrospective cohort study will use data derived from electronic patient records 
collected as part of routine patient care. It will be conducted at Portsmouth Hospitals University Trust 
NHS Trust, a large acute District General Hospital. Logistic regression and other classical statistical 
techniques will be used to predict the risk of death for different treatment methods and to identify 
clusters of patients with the same characteristics. This will allow identification of lower-risk treatment 
options for different patient groups. 
 
7.2 
Primary and Secondary Endpoints/Outcome Measures 
The primary outcomes to be assessed will be length-of-stay, in-hospital, short-term (30-day), and 
long-term (1- year) mortality.  
Secondary outcomes include: long-term complications, such as re-admission to hospital, additional 
abdominal surgery and the development of new medical conditions as well as the relationships 
between any of these outcomes and patient characteristics. 
 
7.3 
Study Setting 
This single-centre retrospective cohort study will use data derived from electronic patient records 
collected as part of routine patient care. It will be conducted at Portsmouth Hospitals NHS Trust 
(PHUT), a large acute District General Hospital. Logistic regression and other classical statistical 
techniques will be used to predict the risk of death for different treatment methods and to identify 
clusters of patients with the same characteristics. This will allow us to identify lower-risk treatment 
options for different patient groups. 
 
Portsmouth hospital provides acute services to a population of about 860,000 people, covering a mix 
of rural, urban and coastal areas. Portsmouth is the most densely populated city in the UK. 
Interspersed with areas that attract well-educated professional families and wealthy retired residents, 
Portsmouth has several areas of ‘multiple deprivation’ and it's in the top 20% of areas in England for 
deprivation (deprivation index 27.1, England average 21.8) (23). It’s a very diverse city with a large 
student and military service population as well as a high number of elderly people in their 80s and 90s. 
In 2015-2016, PHUT was placed 120 out of 135 acute trusts in England, according to the 
standardised hospital mortality index (SHMI) (24). Preliminary analysis using the Dr. Foster 
Healthcare Intelligence Portal showed that mortality of patients with abdominal emergencies admitted 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 14 of 24 
 
 
 
to Portsmouth Hospital Trust in 2018 was in line with the national average. In other words, Portsmouth 
is a representative microcosm of the UK in terms of its demographic profile and hospital performance.  
PHUT is, however, exceptional as it performs an unusually large proportion of laparoscopic 
procedures every year making it ideally suited for this study. 
7.4 
Study cohort 
Data will be derived from electronic patient records collected as part of routine clinical patient care on 
all general adult wards (excluding maternity) between 2013 (beginning of NELA and collection of data 
of interest) and 2020. 
 
All patients with a condition that would qualify them for emergency abdominal surgery will be 
identified, using their ICD-10 diagnosis and OPSC-4 procedure codes which are part of the electronic 
patient record. Once patients have been identified, they will be screened against the 
inclusion/exclusion criteria (see below). For each patient, this will include only the first intervention 
within the study period in the analysis. Subsequent admissions with an abdominal condition or 
subsequent interventions will be classified as complication and therefore considered as an outcome. 
 
Inclusion criteria: 
• 
Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes 
• 
Must be >= 16 years of age at the time of admission 
• 
Have at least one full set of vital signs recorded on the day of admission 
• 
Have at least one full set of routine blood tests recorded on the day of admission 
 
Exclusion criteria: 
• 
Maternity admissions during/after pregnancy 
• 
Patients admitted or undergoing abdominal surgery for a second time or more 
 
8. 
SAMPLE SIZE 
This study will identify patients diagnosed with an intestinal emergency who may require surgery and 
observe patient outcomes, and how they correlate with the treatment they received. Trial analysis of 
all admissions in 2018 identified 901 patients with an abdominal emergency, 59% (530) of which had 
surgical intervention, either a laparotomy or a laparoscopy. Scaling these numbers to the study period 
of 6.5 years, we expect to identify a total of over 5,800 patients with an intestinal emergency and over 
3,400 patients undergoing surgery. All UK hospitals have to submit data on all their intra-abdominal 
procedures to the National Emergency Laparotomy Audit (NELA). From previous analysis of PHUT 
NELA data (11), at least 30% of patients having an operation will have been completed 
laparoscopically. This is a remarkably large proportion of laparoscopic procedures compared to the 
UK average (8% according to NELA database) and will provide us over 1,000 laparoscopies in our 
study data set. 
 
The PHUT data set includes a sufficient number of outcomes for model development (rule of thumb: 
10 outcomes per predictor variable (25)). This study will be looking at a patient population with high 
mortality. Initial analysis of 2018 data identified in-hospital mortality as the rarest outcome with 23 
deaths (4.3%) of patients having surgery and 28 deaths (7.6%) of patients not having surgery. Other 
outcomes occur in greater numbers. Collective numbers for the 6.5 year study period will therefore 
provide us with enough outcomes for the development of logistic regression models. The data set will 
be tested for separation and Firth’s correction applied if necessary (26). Based on these numbers, we 
will be able to establish statistically significant correlations from this data set from a single hospital. 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 15 of 24 
 
 
 
9. 
DATA HANDLING AND RECORD KEEPING 
9.1 
 Data collection and extraction 
Data will be derived from electronic patient records collected as part of routine clinical patient care on 
all general adult wards (excluding maternity) between 2013 (beginning of NELA and collection of data 
of interest) and 2020. Electronic records will include patient demographics, diagnosis and procedure 
codes held on the Patient Administration System (PAS), vital sign observations from the VitalpacTM 
system, routine blood tests from the pathology database, surgery-specific data from TheatreManTM 
and additional data from the National Emergency Laparotomy Audit (NELA; which is only available for 
patients who underwent laparotomy). Linked data sets will provide information on length-of-stay in-
hospital mortality, 30-day mortality, 1-year mortality, re-admission to hospital and subsequent 
abdominal surgery. 
9.2 
     Data Management 
All data will be pseudonymised at the point of extraction and the national opt-out will be applied. 
Identifying characteristics (name, address, date of birth) will be replaced by a study identification 
number (ID) - age will be recorded as it is required for the analysis. The mapping key will only be 
known to the data manager and kept in a secure location at PHUT. De-identified data will be held in 
secure clinical data repositories that will only be accessible by relevant members of the research team 
for the purpose of this study. 
 
10. DATA ANALYSIS 
10.1 
   Data set 
Patient data will include information on age, demographics, diagnosis, co-morbidities, frailty, vital 
signs and blood tests as potential risk factors associated with mortality. Each patient’s National Early 
Warning Score (NEWS) will be calculated using their vital signs (21), and their Laboratory Decision 
Tree Early Warning Score (LDTEWS), based on blood test results. The combined LDTEWS:NEWS 
risk index is a highly accurate predictor of patient deterioration (unintended admission to intensive 
care and death) within 24 hours (27). 
 
Outcomes 
The primary outcomes to be assessed will be length-of-stay, in-hospital, short-term (30-day), and 
long-term (1- year) mortality. This study will also assess long-term complications, such as re-
admission to hospital, additional abdominal surgery and the development of new medical conditions. 
Additionally, it will observe any relationships between these outcomes and patient characteristics. 
10.2 
 Data analysis 
Extracted data will be cleaned and quality controlled prior to analysis to ensure all relevant patients 
have been extracted. Given that our analysis will use only routinely collected, clinical data, missing 
values are unlikely to pose an issue. Initial analysis of 2018 data confirmed that clinical data within 
24h of admission was almost fully complete for a remarkable >97% of admissions, meaning there is 
likely no need to impute data. We will test whether excluding admissions with missing data will 
introduce bias. 
Our analysis can be broken down into the following steps: 
• 
Comparison of the four treatment groups based on demographics, outcomes and medical 
pathway. This will include calculating mortality and long-term complication rates (Objective 2). 
• 
Construct and compare risk models for each treatment group to predict short-term and long-
term risk and to investigate the effect of both patient and hospital-level factors on outcome 
(Objective 3). 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 16 of 24 
 
 
 
• 
Identify patients in each group who are abnormal for the group and might have fared better 
with a different treatment, using clustering algorithms (Objective 4). 
 
After splitting the data set into subsets for each of the four patient groups using diagnosis and 
procedure codes (see above), mortality and long-term complication rates will be calculated for each 
group. Longer-term follow-up will include rates of re-admission to hospital, additional theatre visits and 
development of new medical conditions, within one year of initial admission with an abdominal 
emergency. Results will provide updated estimates of the average risks of different surgical 
procedures as well as the risk of not having surgery. Results will be compared with P-POSSUM 
mortality. Patient groups will further be characterised the using patient factors. Parameters of interest 
will include but are not limited to age, sex, mortality, long-term complication rates, admission early 
warning scores (NEWS, LDTEWS and LDTEWS:NEWS), frailty, medical history (previous ICD-10 
codes).  
 
Patient group characteristics will be summarised with proportions for nominal and ordinal variables, 
means and standard deviations for continuous variables having symmetric unimodal distributions, and 
medians and interquartile ranges for other continuous variables. Clinical outcomes will be reported as 
proportions with 95% confidence intervals. Statistical tests of differences in proportions (Chi2 - nominal 
variables) and means/medians (ANOVA/Kruskal-Wallis) will be performed. Post-hoc pairwise 
comparisons will be carried out using Scheffe’s method for ANOVA and Dunn’s test for Kruskal-Wallis 
results and Bonferroni corrections for Chi2 results with significance at p<0.05. 
 
In the next step, we will identify which patient characteristics affect the outcome for a specific care 
pathway. Candidate predictor variables of 30-day mortality will be assessed with simple univariable 
linear regression and check for non-linearity. For each treatment group, we will construct a logistic 
regression model with the candidate predictor variables and non-linear terms as needed. Logistic 
regression performance will be tested using “goodness of fit” and discrimination. Goodness of fit, the 
ability to correctly predict risk, will be evaluated using the Hosmer-Lemeshow statistic (28) and by 10-
fold cross-validation. Discrimination, the ability to rank cases in terms of risk, will be assessed using 
the Area Under the Receiver Operating Characteristic Curve (AUROC) (29). The relative importance 
of individual parameters will be assessed by the parameters Wald and t-statistics. 
 
The last objective is to determine outlier clusters of patients who might have fared better on a different 
care pathway. For each treatment group, machine learning classification algorithms will be used to 
identify homogenous clusters of admissions in terms of their attributes. Each clustering will be 
reported by its method, number of clusters and intracluster correlation coefficients (ICCs) with 95% 
confidence intervals and used to extend the logistic regression risk model for the treatment group to 
see if the model is improved as measured by a likelihood ratio test. Where this is the case the patient 
subgroups corresponding to the clusters will be analysed in terms of their clinical characteristics. 
 
11. ETHICS 
The research is not an interventional study and therefore poses negligible risk to patients or other 
participants. It nevertheless requires ethical review as it uses confidential patient data. 
11.1 
    Declaration of Helsinki 
The Investigators will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki.  
11.2 
    ICH Guidelines for Good Clinical Practice 
The Investigators will ensure that this study is conducted in accordance with relevant regulations and 
with Good Clinical Practice.  

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 17 of 24 
 
 
 
11.3 
     Other Ethical Considerations 
Patient identity will be protected by the process of pseudonymisation at data extraction. The national 
opt-out will be applied to the data set and inform patients about their rights on a public project 
webpage.  
 
Ethics Committee (REC) and other Regulatory review & reports 
Before the start of the study, a favourable opinion will be sought from a REC for the study protocol, 
informed consent forms and other relevant documents e.g. advertisements.  
 
Substantial amendments that require review by NHS REC will not be implemented until that review is 
in place and other mechanisms are in place to implement at site.   
 
All correspondence with the REC will be retained. It is the Chief Investigator’s responsibility to produce 
the annual reports as required. The Chief Investigator will notify the REC of the end of the study. 
If the study is ended prematurely, the Chief Investigator will notify the REC, including the reasons for 
the premature termination. The Chief Investigator shall submit on request, a progress report to the 
REC Committee, host organisation and Sponsor. In addition, an End of Study notification and final 
report will be submitted to the same parties.  
 
Regulatory Review & Compliance  
Before any site can enrol patients into the study, the Chief Investigator/Principal Investigator or 
designee will ensure that appropriate approvals from participating organisations are in place.  
For any amendment to the study, the Chief Investigator or designee, in agreement with the sponsor 
will submit information to the appropriate body in order for them to issue approval for the amendment. 
 
Peer review 
The research has been peer reviewed as part of the NIHR funding process. 
 
Patient & Public Involvement 
Patient identity will be protected by the process of pseudonymisation at data extraction. This has 
already been presented to the PHUT Patient Research Ambassador (PRA) group (a mixed group of 
27 people, mostly lay members with some ex-NHS staff). The group met twice with members of the 
study team to review and refine an appropriate design and to consider aspects of sample size, GDPR, 
patient journey etc. The PRA Group routinely edits participant-facing documents such as Patient 
Information Sheets and questionnaires. The group was satisfied that pseudonymisation and data 
handling procedures sufficiently protected patients’ privacy. 
 
Protocol compliance 
All members of the project team will be given copies of this protocol and briefed on its contents. 
Where a deviation from the protocol occurs, this must be documented and reported to the Chief 
Investigator as soon as practicable. Serious deviations, or those that have put at risk confidentiality or 
safety shall also be reported to the Sponsor. 
 
Data protection and patient confidentiality  
The study will comply with the Data Protection Act, which requires personal/identifiable data to be 
anonymised as soon as it is practical to do so. All documents will be stored securely and only 
accessible by study staff and authorised personnel. Data stored will be subject to all standard NHS 
security and confidentiality policies. 
 
The Management Group will have access to all data in order to be able to verify the conclusions of the 
study. Members of the team will have access to data relevant to the publications they are working on. 
The Chief Investigator can approve exceptional access by other members of the project team to 
facilitate analysis or to cover for absences. 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 18 of 24 
 
 
 
12. PATIENT PUBLIC INVOLVEMENT (PPI) 
During the project, PPI members will attend project progress meetings and provide continual 
feedback. In the dissemination phase, they will help develop and publicise the patient information 
leaflets and care pathways in collaboration with our QI Team. 
12.1 
    Study design 
We discussed this project with members of a local patient representative group consisting of patients 
and carers who have years of experience in advising researchers. As a result, one PPI representative, 
Anna Glanville-Hearson has become an integral team member, contributing the development and 
delivery of the project, offering editing/reviewing skills, personal experience of the ED environment 
and of an abdominal emergency in her family. 
 
Key issues raised by our PPI group were: 
• 
Lack of awareness by patients and relatives of the real risks of emergency abdominal surgery 
• 
Limited information on the risks of surgery and potential alternative care pathways available to 
patients and relatives 
• 
Lack of understanding by patients and their relatives of risk levels and how risk can be 
communicated effectively, especially in high-stress emergency situations 
 
Three experienced PPI representatives where consulted who have been involved in previous similar 
projects. They were asked to provide insight into the patient's perspective. They recognised the need 
for more evidence accessible to patients with abdominal emergencies. They also highlighted the 
‘considerable potential to improve patient outcomes’ and ‘that any move to assist patients/relatives to 
make informed decisions taken in stressful situations on their care, together with a proper awareness 
of the risks will be beneficial’. 
The project was specifically shaped around these key PPI concerns, as evidenced by our intended 
outputs of clearer patient information and better care pathways above. 
12.2 
    Study implementation 
At project start-up, a group of at least one representative (patient/relative) for each of the four 
proposed care pathways for abdominal emergencies will be consulted. This patient-focused group will 
provide patient insights and will identify what information would have improved their experience.  
12.3 
    Dissemination 
Towards the end of the project, the same group will be consulted to present and discuss our results 
and seek feedback on our patient information leaflet. 
 
While PPI team members will not be involved in data analysis but they will have an important role in: 
• 
Working with QI representatives to develop new documented care pathways for patients with 
abdominal emergencies. 
• 
Developing patient-facing documents that help patients and relatives to quickly understand 
the personalised risk of surgical and non-surgical options even under stress. The PHUT PPI 
team will ensure that the information leaflet is accessible to many patients, including non-
English speakers, people without any medical knowledge, learning difficulties or other 
incapacities. 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 19 of 24 
 
 
 
13. FINANCING AND INSURANCE 
13.1 
Staff costs 
The project requires a team with diverse skills and knowledge to manage the project, set up the 
project database, collect data on observation workload and to analyse the complex data set. The 
costs requested fairly reflect this complex multi-disciplinary project involving surgical, informatics and 
analytical expertise. 
 
The project costs requested cover significant and sustained input from the CI (ST @7.5%) who will 
provide clinical expertise, overview and supervision of the data extraction and accuracy, and then lead 
stakeholder engagement and dissemination, including the application for funds for a Wessex QI 
Project to develop the pathways and patient information outputs from this project. He will also manage 
the project day-to-day. He will be supported by co-CI, JB (@5%) who will assist in meeting regulatory 
requirements (research ethics, data protection etc.) and an administrator (@6%). Based on previous 
experience with similar studies, this combined CI commitment of 12.5% of our time will deliver this 
study on time and to budget. 
 
The largest portion of the budget will cover the salary of the data analysis team, which involves a 
research fellow (IK @50%) who will lead the data analysis with the assistance of an experienced 
health informatician (DP @10%, not requested). Data analysis will also involve a more junior research 
associate (@20%) who will provide technical skills and support. Data extraction and integration will be 
led by PM (@15%) at PHT who will also contribute advice on the data sources. PM will also provide 
additional statistical expertise to the data analysis. A clinical research fellow will assist with data 
extraction and provide supplementary clinical input (AD @20%). 
PPI support will be provided by SC, the facilitator of the PHT Patient Research Ambassador group 
(@3%). 
13.2 
Travel, subsistence and conference fees 
The budget includes cost for travel and catering for the stakeholder meeting planned for the 2nd year of 
the project (£500). In addition, costs for travel, subsistence and registration fees for several members 
of the team (£1.5k) to present the research at national conferences throughout the project have 
included. 
13.3 
Dissemination costs 
Funding for dissemination comprises article processing charges for 2 open access publications (£4k). 
13.4 
Equipment and consumables 
High-performance computer workstations are already available for all members of the research team 
and no additional equipment or consumables are required. 
13.5 
Patient and public involvement 
Budget also includes costs for PPI (at rates recommended by Involve, total £1.2k). This will: 
• 
reimburse members of the PPI team for their time and travel expenses (£210) 
• 
reimburse Anna Glanville-Hearson for her time, attending bi-monthly progress meetings 
throughout the project (£524) 
• 
cover the costs for the 4 PPI representatives attending the 2 consultation meetings (£466). 
13.6 
Any other direct costs 
Maintenance for the database infrastructure at PHT (£5.6k). 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 20 of 24 
 
 
 
14. TIMETABLE AND ORGANISATIONAL CHART 
14.1 
Key milestones (by month). 
M01 - Project initiation. Initial stakeholder consultation. 
M04 - Ethical review obtained. Data extraction complete. 
M12 - Progress report to RfPB. Advisory Group meeting. 
M13 - Data analysis complete. First paper completed. 
M16 - Second paper completed. 
M18 - Final report submitted. Engagement with stakeholders completed. 
 
14.2 
 Project management 
The project will be overseen and managed by Mr. Toh with support from Prof Briggs. There will be 
monthly project meetings involving the leads and other team members to review and coordinate 
progress towards milestones. The project plan allows significant periods of time for ethics approval, 
data extraction, and quality control, as well as for modelling and analysis. This is based on our past 
experience of the complexities of these tasks, which in turn is based on the complexities of the data 
under consideration. If progress goes faster than expected, then more time will be devoted to the 
dissemination of the patient information and care pathways. 
For strategic oversight and advice, a Project Advisory Group will be established, including senior 
clinicians and data scientists, key stakeholders and patient and public representatives, some of whom 
have already advised us on this project. This group will meet at the halfway mark to review progress 
and provide in-depth feedback and guidance on dissemination and project outputs.

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 21 of 24 
 
 
 
Activity 
Duration 
Pre-project 
start 
M 1 
M 2 
M 3 
M 4 
M 5 
M 6 
M 7 
M 8 
M 9 
M 10 
M 11 
M 12 
M 13 
M 14 
M 15 
M 16 
M 17 
M 18 
Project management and 
administration 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Ethics application  
4m 
x 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Management group 
meetings  
  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Progress report to NIHR  
  
  
  
  
  
  
  
  
  
  
  
  
  
x 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Data extraction and analysis 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Prepare for data extraction 
2m 
  
x 
x 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Data extraction and cleaning 
3m 
  
  
x 
x 
x 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Descriptive analysis 
(Objective 2) 
5m 
  
  
  
  
x 
x 
x 
x 
x 
  
  
  
  
  
  
  
  
  
  
Outcome modelling 
(Objective 3) 
4m 
  
  
  
  
  
  
  
x 
x 
x 
x 
  
  
  
  
  
  
  
  
Cluster analysis (Objective 4) 
4m 
  
  
  
  
  
  
  
  
  
  
x 
x 
x 
x 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Dissemination 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Stakeholder engagement and 
presentation of results 
5m 
x 
x 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
x 
x 
x 
Advisory group meeting 
1m 
  
  
  
  
  
  
  
  
  
  
  
  
x 
  
  
  
  
  
  
Draft paper 1  
3m 
  
  
  
  
  
  
  
  
  
  
  
x 
x 
x 
  
  
  
  
  
Draft paper 2 
3m 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
x 
x 
x 
  
  
Prepare final report 
3m 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
x 
x 
x 
 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 22 of 24 
 
 
 
15. DISSEMINATION AND OUTCOME 
15.1 
Outputs 
Results will be published in leading peer-reviewed surgical journals on: 
1. Comparisons of acute abdominal patients’ characteristics and outcomes between those who 
have an emergency laparotomy and those who do not. 
2. Towards Best Care Pathways and better patient information for different groups of patients 
admitted with abdominal emergencies. 
Our findings will inform the development of new care pathways and patient information using Quality 
Improvement (QI) methodology with the help of our PPI team members and the PHT QI Team. 
Additional funds for implementation will be sought from an HEE Wessex School of QI Support Fund 
(30). Mr.Toh and his Creative Media team in the UoP will use our expertise in producing award-
winning patient informatics to design and test patient leaflets/video animations (31). These will be 
made available online for all NHS Trusts to access, for example, on the HealthPathways site being 
rolled out in the NHS (32). 
 
15.2 
Dissemination 
Regionally, findings will be presented to the Wessex Emergency Laparotomy Programme partners, 
reaching every Wessex hospital. Specifically, patient information leaflets and best care pathways will 
be shared freely, via partners from the Emergency Laparotomy Collaborative (33), with all acute 
surgical teams in the UK and to the wider public through the Academic Health Science Network 
Patient Safety Collaborative (34) and a website. We will engage with our key stakeholders (Prof. Peter 
McCulloch (IDEAL Collaborative) and the Royal College of Surgeons of England) to implement these 
findings by including them in future publications of RCSE guidelines. Results will be presented at key 
conferences including the Association of Surgeons of Great Britain and Ireland, the United 
European Gastroenterology Week, and Health Service Journal Conference targeting NHS leaders. 
15.3 
Next steps 
This study is a necessary first step to provide evidence for the design of future research, such as a 
larger multicentre study by giving us data on overall risks and likely patient and admission factors that 
could affect them. The planned, larger study will analyse and model these factors statistically to 
develop a replacement for P-POSSUM (18), which is the outdated risk-prediction tool currently 
commonly used (6,11). This novel tool will be able to predict the risk of any intervention (or no 
intervention) in patients with an acute abdomen more accurately than before. This will in turn help 
surgeons provide truly individualised informed consent to patients on their choices and predicted risks 
(35). This fulfils the goal for a more personalised medical care within the NHS 
(36). 
 
16. REFERENCES 
1. Fourth Patient Report of the Emergency Laparotomy Audit. Royal College of Anaesthetists, 2018. 
2. The Higher Risk General Surgical Patient. Royal College of Surgeons England, 2011. 
3. Emergency Surgery: Standards for Unscheduled Care. Royal College of Surgeons England, 2011. 
4. Second Patient Report of the National Emergency Laparotomy Audit. Royal College of 
Anaesthetists, 2016. 
5. First Patient Report of the National Emergency Laparotomy Audit. Royal College of Anaesthetists, 
2015. 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 23 of 24 
 
 
 
6. Third Patient Report of the National Emergency Laparotomy Audit. Royal College of Anaesthetists, 
2017. 
7. A prospective cohort study characterising patients declined e emergency laparotomy: survival in the 
‘NoLap’ population. E C McIlveen, E Wright, M Shaw, J Edwards, M Vella, T Quasim, and S J Moug. 
Anaesthesia, Vol. 201, 2019. 
8. A systematic review comparing laparoscopic vs open adhesiolysis in patients with adhesional small 
bowel obstruction. M S Sajid, A H Khawaja, P Sains, K Singh and M K Baig. The American Journal of 
Surgery, Vol. 212, 2016. 
9. Laparoscopic lavage is superior to colon resection for perforated purulent diverticulitis—a 
metaanalysis. E Angenete, D Bock, J Rosenberg, and E Haglind. International Journal of Colorectal 
Disease, 2017. 
10. Meta-analysis of perioperative outcomes of acute laparoscopic versus open repair of perforated 
gastroduodenal ulcers. R Cirocchi, K Soreide, S Di Saverio, E Rossi, A Arezzo, M Zago, I Abraha, N 
Vettoretto, and M Chiarugi. Journal of Trauma and Acute Care Surgery, Vol. 85, 2018. 
11. Impact of laparoscopic approach in emergency major abdominal surgery: single-centre analysis of 
748 consecutive cases. P H Pucher, N C Carter, B C Knight, SKC Toh, V Tucker, and S J Mercer. The 
Annals of The Royal College of Surgeons of England, Vol. 100, 2018. 
12. Laparoscopy in major abdominal emergency surgery seems to be a safe procedure. L B J Nielsen, 
L Toft Tengberg & M Bay Nielsen. Danish Medical Journal, Vol. 64, 2017. 
13. Severe Gastrointestinal Haemorrhage: Summary of a National Quality of Care Study with Focus 
on Radiological Services. SJ McPherson, M T Sinclair, and N C E Smith. Cardiovasc Intervent 
Radiology, Vol. 40, 2016. 
14. Image-guided percutaneous drainage: a review. Nelson, T A Jaffe and C Rendon. Abdominal 
Radiology, Vol. 41, 2016. 
15. Embolization for non-variceal upper gastrointestinal tract haemorrhage: A systematic review. S 
Mirsadraee, P Tirukonda, A Nicholson, S M Everett, and S J McPherson. Clinical Radiology, Vol. 66, 
2011. 
16. Systematic review and meta-analysis of randomized clinical trials of self-expanding metallic stents 
as a bridge to surgery versus emergency surgery for malignant left-sided large bowel obstruction. C J 
Tan, B V M Dasari, and K Gardiner. British Journal of Surgery, Vol. 99, 2012. 
17. Systematic review of survival after acute mesenteric ischaemia according to disease aetiology. I G 
Schoots, G I Koffeman, D A Legemate, M Levi, and T M van Gulik. British Journal Surgery, Vol. 91, 
2004. 
18. POSSUM and Portsmouth POSSUM for predicting mortality. D Prytherch, Whiteley, Higgins, 
Weaver, Prout, and Powell. British Journal of Surgery, Vol. 85, 1998. 
19. Validation of long-term survival prediction for scheduled abdominal aortic aneurysm repair with an 
independent calculator using only pre-operative variables. J B Carlisle, G Danjoux, K Kerr, C 
Snowden, and M Swart. Anaesthesia, Vol. 70, 2015. 
20. ViEWS - Towards a national early warning score for detecting adult inpatient deterioration. D R 
Prytherch, G B Smith, P E Schmidt, and P I Featherstone. Resuscitation, Vol. 81, 2010. 
21. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early 
cardiac arrest, unanticipated intensive care unit admission, and death. G B Smith, D R Prytherch, P 
Meredith, P E Schmidt, and P I Featherstone. Resuscitation, Vol. 84, 2013. 
22. National Early Warning Score (NEWS): Standardising the assessment of acute illness severity in 
the NHS. Royal College of Physicians. Report of a working party. 2012. 
23. Health Profiles. Public Health England. 2017. 
24. Developing a summary hospital mortality index: retrospective analysis in English hospitals over 
five years. M J Campbell, R M Jacques, J Fotheringham, R Maheswaran, J Nicholl. BMJ, Vol. 344, 
2012, doi:10.1136/bmj.e1001. 

Date and Version No: 
2020-Sep 
v0.1 
 
 
 
The BCAE Study 2020 
 
 
Page 24 of 24 
 
 
 
25. A Simulation Study of the Number of Events per Variable in Logistic Regression Analysis. P 
Peduzzi, J Concato, E Kemper, T R Holford, A R Feinstein. Journal of Clinical Epidemiology, Vol. 49, 
No. 12, 1996. 
26. No rationale for 1 variable per 10 events criterion for binary logistic regression analysis. M van 
Smeden, J A. H. de Groot, K G. M. Moons, G S. Collins, D G. Altman, M J. C. Eijkemans and J B. 
Reitsma. BMC Medical Research Methodology, Vol. 16, 2016. 
27. Predicting in-hospital mortality and unanticipated admissions to the intensive care unit using 
routinely collected blood tests and vital signs - Development and validation of a multivariable model. 
O C Redfern, M A F Pimentel, D Prytherch, P Meredith, D A Clifton, L Tarassenko, G B Smith, and P J 
Watkinson. Resuscitation, Vol. 133, 2018. 
28. Applied Logistic Regression, 3rd Edition. D W Hosmer Jr., S Lemeshow, R X Sturdivant. ISBN: 
978-0-470-58247-3, 2013. 
29. Comparing the areas under two or more correlated receiver operating characteristic curves: a 
nonparametric approach. E R DeLong, D M DeLong, D L Clarke-Pearson. Biometrics, Vol. 44, 1988. 
30. http://www.wessexdeanery.nhs.uk/quality_improvement.aspx 
31. Award-winning smartphone QR-code accessed video-animations for educating surgical patients 
on risks and prevention of Hospital Acquired Thrombosis. SKC Toh, T Meredith, British Journal of 
Surgery, Vol.105, suppl.5 2018 
32. Implementing online evidence-based care pathways: A mixed-methods study across primary and 
secondary care. J Akehurst, Z Sattar, I Gordon and J Ling. BMJ Open, Vol. 8, 2018. 
33. https://emergencylaparotomy.org.uk/ 
34. https://wessexahsn.org.uk/programmes/21/patient-safety-collaborative 
34. Changes to the law on consent following Montgomery vs Lanarkshire Health Board. L Learkin. 
British Journal for Hospital Medicine, Vol. 77, 2016. 
35. https://www.england.nhs.uk/wp-content/uploads/2016/09/improving-outcomes-
personalisedmedicine.pdf 
36. Hospital-wide physiological surveillance—A new approach to the early identification and 
management of the sick patient. G B Smith, D R Prytherch, P Schmidt, P Featherstone, D Knight, G 
Clements, M A Mohammed. Resuscitation, Vol. 71, 2006. 
37. Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in 
Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial. J 
Shalhoub, J Norrie, C Baker, A W Bradbury, K Dhillon, T Everington, M S Gohel, Z Hamady, F 
Heatley, J Hudson, B J Hunt, R Lawton, G Stansby, A Stephens-Boal, S Toh, D Warwick, A H Davies, 
GAPS Trial Investigators. Eur J Vasc Endovasc Surg, Vol 53, 2017. 
38. Frailty and Sarcopenia Outcomes in Emergency General Surgery 
https://clinicaltrials.gov/ct2/show/NCT0353476525. 
39. Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh 
(Dynamesh®-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC 
Study. S Toh, B Knight, C Fogg, E Baddesley, A Higginson, R Beable, S Babu, E Hawes, M Moon, J 
Shoebridge, P Meredith, M Amos and P May-Mille. International Journal of Surgery, Vol. 59, 2018. 
40. Incidence and estimated annual cost of emergency laparotomy in England: is there a major 
funding shortfall? Shapter SL, Paul MJ, White SM. Anaesthesia. 2012 May;67(5):474-8