SAS Pilot Protocol
Surgical Apgar Score in clinical practice: a pilot study
Version 5.2p
07/12/2010
Scientific Details ................................................................................................................................ 2
Ethics and Governance .................................................................................................................... 8
Appendix 1: Summary of data to be collected ............................................................................ 15
Appendix 2: Major complication definitions and classification ................................................ 17
Appendix 3: Guide to site implementation.................................................................................. 18
Project Documents.......................................................................................................................... 21
Version History ................................................................................................................................ 22
References......................................................................................................................................... 24
SAS Pilot Protocol
Scientific Details
Background
Surgeons lack a routine, objective evaluation of patient condition after surgery. We
currently rely on subjective assessment of available patient data. The current scoring
methods such as APACHE and POSSUM are complex and cumbersome and have
therefore not been adopted into routine practice 1.
The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3
parameters collected during the operation: lowest heart rate, lowest blood pressure,
estimated blood loss (Table 1).
Previous validation studies have shown a good correlation between the score and
incidence of major complications or death occurring within 30 days (Table 2). To date, the
SAS has never been clinically applied and tested in a trial.
We believe that routine use of the SAS will lead to a reduction in major complications
and deaths after surgery. We also believe that it will lead to a reduction in the severity of
the complications.
This is based on our theory that the SAS eliminates the guesswork. Using this score will
add objectivity and clarity to clinical decisions that are presently based on clinical instinct or
'gut feeling'. The score will more clearly highlight those patients who are at an increased
risk of developing complications or dying and will flag them up for increased monitoring, a
higher index of clinical suspicion and a lower threshold for early management of problems.
Table 1. The 10-Point Surgical Apgar Scorea.
Surgical Apgar Score. No. of Points
0
1
2
3
4
Estimated blood loss, mL
>1000
601-1000
101-600
≤100
Lowest mean arterial pressure, mmHg
<40
40-54
55-69
≥70
Lowest heart rate/min
>85b
76-85
66-75
56-65
≤55b
aThe Surgical Apgar Score is calculated at the end of any general or vascular surgery operation from the
estimated blood loss, lowest mean arterial pressure, and lowest heart rate entered in the anaesthesia
record during the operation. The score is the sum of the point from each category.
bOccurrence of pathologic bradyarrhtymia, including sinus arrest, atrioventricular block of dissociation,
junctional or ventricular escape rhythms, and asystole, also receives 0 points for lowest heart rate.
Table 2. Thirty-day major complications and deaths among 4119 general and vascular surgery patients in
relation to Surgical Apgar Scorea.
Score
0-2
3-4
5-6
7-8
9-10
No. of patients
16
112
720
1830
1441
Major complications, No.
12 (75)
60 (54)
201 (28)
236 (13)
72 (5)
(%)
Relative risk (95% CI)
15.0
10.7
5.6
2.6
1
(10-5-21.5)
(8.1-14.2)
(4.3-7.2)
(2.0-3.3)
[Reference]
Deaths, No. (%)
7 (44)
18 (16)
33 (5)
34 (2)
2 (0.1)
Relative risk (95% CI)
315.2
115.8
33.0
13.4
1
(70.9-1401.8)
(27.2-492.7) (7.9-137.2)
(3.2-55.6)
[Reference]
aMajor complication and death rates are shown according to the 10-point Surgical Apgar Score from the
operation. Patients with scores of 9 or 10 served as the reference group. Risk of major complications and
death decreased significantly with increasing scores (Cochran-Armitage trend test, both P<.001). CI
indicates confidence interval.
Version 5.2p | 12/7/2010 | Page 2 of 24
SAS Pilot Protocol
Previous studies
The Surgical Apgar Score was designed in 2007 by prospectively analysing perioperative
data in general or vascular surgical procedures and identifying the main influential
parameters2. It was then validated in 2009 through retrospective collection of data from
general and vascular surgical procedures3. It was also validated in 2009 in a retrospective
analysis of the score’s predictive power in radical cystectomy4. To date, there are no
prospective studies.
Primary Aim
The primary aim of the pilot is to strengthen the design and assess the feasibility of the
main study on the Surgical Apgar Score (SAS). We aim to recruit 100 patients in each
group, 200 in total. The main areas to assess are:
1. the feasibility of our protocol for the main study;
2. the ability of the study design to achieve a clear answer to our research question;
3. the impact and cost of the potential increased monitoring and treatment in the
intervention group;
4. the potential pitfalls and areas of bias;
5. the accuracy of our sample size estimate for the future RCT, currently 2200.
The primary aim of the main study is to establish if clinical application of the SAS leads to
a reduction in 30-day post-operative morbidity and mortality.
Hypothesis
The SAS facilitates clinicians in making an objective assessment of the patient’s postoperative prognosis and increase resources and attention on those with an increased risk of
major complications and death, leading to better care and a decrease in the number of
major complications and death.
Study Design
The design of this pilot is the same as what the RCT will eventually be: a multicentre
single-blind RCT (Figure 1). This study design has been chosen as it offers the most
accurate way in which to answer our research question and allows us to eliminate sources
of bias. We are planning this as a multicentre trial, so that we recruit enough patients within
a reasonably short time span.
Inclusion Criteria
All the following must be met:
 Adult (18+ years)
 General or vascular surgery
 Emergency or elective surgery
 Operation will require routine outpatient follow-up
 Patient has capacity to give informed consent at the time of recruitment
Version 5.2p | 12/7/2010 | Page 3 of 24
SAS Pilot Protocol
Figure 1. Flowchart showing patient's progress through study.
Version 5.2p | 12/7/2010 | Page 4 of 24
SAS Pilot Protocol
Recruitment and Consent
The surgeons will identify the patient during the pre-operative period. Those who meet the
inclusion criteria should be approached during the pre-operative consent. The trial is
explained and a patient information leaflet is supplied. If possible, the patient should be
given some time to think / discuss with others so as not to risk coercion. Once consent is
given, the patient should sign the consent form and the surgeon should complete the
registration proforma.
Operative data collection
Procedure for data collection at end of operation:
 The surgeon will ask the anaesthetist for the required data
 The data will be recorded by the surgeon on the proforma (this is to reduce
recorder bias)
Randomisation
After operative data collection at the end of the operation the surgeon should then use the
randomisation website to allocate the patient into either the control or intervention group.
This is stratified by ASA grade (I-II or III-V), NCEPOD status (elective or emergency) and
the hospital site to ensure balanced cofounding factors.
Blinding
Single-blinding: only the patient will be kept blind. It is not possible to build in doubleblinding and observer-blinding would require a significant amount of extra resources.
Control Arm
Patients will be managed as per standard clinical care without knowledge of the SAS.
Intervention arm
The SAS will be calculated from the collected operative data. The following measures,
stratified according to the score should be followed, but in all cases the surgeons and
doctors will be free to exercise their own clinical judgement.
 SAS=0-4 High risk (60%) of complications
Discuss with ITU/HDU and request a review to consider admission
Prescribe antibiotic, stress ulcer and DVT prophylaxis if considered beneficial
Handover to surgical colleague to review patient at 4 and 8 hours post-op (this
should specifically include review of vital signs, urine output and pain)
Plan twice daily reviews thereafter
 SAS=5-8 Average risk (15%) of complications
Prescribe antibiotic, stress ulcer and DVT prophylaxis if considered beneficial
Handover to surgical colleague to review patient at 8 hours post-op (this should
specifically include review of vital signs, urine output and pain)
Plan twice daily reviews thereafter
 SAS=9-10 Low Risk (5%) of complications
Manage patient as per standard clinical care
Version 5.2p | 12/7/2010 | Page 5 of 24
SAS Pilot Protocol
Outcomes
Outcome data will be collected by the surgeon at the follow-up clinic appointment or on a
ward review if the patient is still in hospital 30 days post-op. All outcomes captured are
those that occurred within 30 days of the operation. Any that occurred later than this
should not be captured.
Primary outcome (within 30 days of operation):
 Major complications or death
Secondary outcomes (within 30 days of operation):
 Minor complications
 Primary ITU/HDU admission and length of stay
 Secondary ITU/HDU admission and total length of stay
 Duration of therapeutic antibiotics
 Number of additional operations under GA to treat complications
 Overall length of stay
 Performance difference between first half and second half of study (are clinicians
being educated by the process and therefore improving in their overall practice?)
Lost-to-follow-up Strategy
The aim is to achieve at least 95% complete follow-up. The following strategies may be
employed to achieve this. If the patient does not turn up to their clinic appointment:
 Send out another clinic appointment
 Telephone individually and encourage to attend clinic
 If unsuccessful, conduct a telephone interview – if this flags up any complications
then patient should be encouraged to attend clinic
Data Collection Methods
 Consent forms will be filed in a separate confidential file and held secure in the
R&D department (to comply with governance requirements).
 Data will be collected locally on proforma sheets. As they contain patient
identification details, they will be kept in confidential files in a locked cabinet in a
locked room.
 Data will be inputted into a local Microsoft Access database that will be password
protected and stored on the local Trust secure servers.
 When data collection is complete, the patient identification details will be stripped
from the database before central collection, ensuring anonymity of patient,
consultant and trust.
Sample Size
Current data suggests the overall expected major complication or death rate in our target
population would be 21%. The sample size of the future RCT is there fore estimated to be
986 each group to detect a 5% reduction in complications (Significance 0.05%, Power
80%).
Version 5.2p | 12/7/2010 | Page 6 of 24
SAS Pilot Protocol
We wish to conduct a pilot study first on a sample size that is 10%, which is
approximately 100 in each group, 200 in total
Analysis
Once recruitment and follow-up has been completed for 200 patients the pilot study will
end and local data will be made anonymous before collating for statistical analysis.
Version 5.2p | 12/7/2010 | Page 7 of 24
SAS Pilot Protocol
Ethics and Governance
Ethics
This study has been reviewed and approved by East London 3 Research Ethics
Committee.
Risks
There is no perceivable risk to the patient. We have been careful to design the trial so that
the outcomes will be either the same or better than if the patient was not to enter the trial.
There will be no experimental treatment and no rationing of care. The clinical staff will be
permitted to exercise their usual practice without hindrance or restriction. It is expected
that those on the intervention arm will actually receive more attention and a higher level of
care as a result of the trial.
The burden on the patient is minimal as there will be no extra examinations, tests or
interviews. All the data can be collected from clinical activities that are part of the current
practice. The only extra activity is the initial recruitment and consent, which should take
about 15 minutes.
Safety Reporting
Should an adverse event occur as a direct result of the trial then local NHS services should
be used to meet the needs of the patient. This is considered appropriate as the sponsor for
the study is an NHS trust. The following actions should be taken:
1. Assess and treat the patient with appropriate urgency using the NHS services
available locally, including A&E and hospital clinical emergency systems
2. Inform the Chief Investigator immediately on 07788723535 (24-hours, message
service if no answer)
3. Trigger local investigation by submitting a clinical incident form
4. Inform local R&D department
Costs
The total cost that needs to be met is £270. Our cost analysis has been performed using
the Barts & The London costing template and a breakdown is shown in Table 3.
At this stage it is very hard to predict how much effect the SAS will have on the clinical
decisions. We do not know if, as a result of the trial, patients will receive more or less
treatment. Therefore it is very difficult to estimate if there will be additional costs for
supporting patient care and if there will be any excess treatment. This section on the
finance form has been left blank. We will have a better idea of these potential costs after
this pilot study.
The staffing costs of the project (Table 4) are already met. The investigators all have
time in their weekly schedule formally allocated to research and study as part of their
contracts. This time will be donated to the project.
Version 5.2p | 12/7/2010 | Page 8 of 24
SAS Pilot Protocol
Table 3. Costs needing to be met.
Item
Statistician
Randomisation Website
Stationary
Archives
Total
Table 4. Costs already met.
Item
Investigator (Registrar)
Investigator write-up
Total
Cost
£120
£0
£100
£50
£270
Cost
£8,300
£1,244
£9,544
Funding
Funding application to National Institute for Health Research Research for Patient Benefit
competition 12 was unsuccessful. The pilot study can still continue as the costs needing to
be met are minimal and can be absorbed within existing department budgets.
Project Management
The project is being run by the London Surgical Research Group. We are a research
network of 180 members that is led by higher surgical trainees in London, and headed by
Mr Charles Knowles, Senior Lecturer and Honorary Consultant, Academic Surgical Unit,
Centre for Digestive Diseases, Institute for Cell and Molecular Science, Barts and The
London School of Medicine and Dentistry. By working together, trainees who as part of
their training are placed in various hospitals across London and the South East, can use
this network to facilitate large multicentre studies on surgical research topics. This allows
the collection of large amounts of data in a relatively short period of time, leading to
statistically powerful results.
The group's steering committee meets every month to discuss the progress of the
project, identifying issues and sticking points causing delays and areas that require
attention, resources or management. There is also direct liaison between the Chief
Investigator and the Director of the lead R&D office (Barking, Havering and Redbridge
University Hospitals NHS Trust) to ensure all governance standards are met. The lead
organisation R&D and finance offices will provide financial management.
Methods of Disseminating Findings
We will disseminate our findings through academic and public channels: presentation at
Association of Surgeons of Great Britain and Ireland annual scientific conference,
presentation at the Patient Safety Congress sponsored by the NPSA, submission for
publication in the British Journal of Surgery, and e-newsletter to participants who subscribe
to the mailing list.
Project Timeline
The project timeline can be seen in Figure 2.
Version 5.2p | 12/7/2010 | Page 9 of 24
Figure 2. Gantt chart showing project timeline.
SAS Pilot Protocol
Version 5.2p | 12/7/2010 | Page 10 of 24
SAS Pilot Protocol
Project Management Information
Main Investigation Team
Chief Investigator
Mr Sabu Jacob
Study Co-ordinator
Mr James Haddow
Principal Investigator (KGH)
Mr Wayne Chicken
Principal Investigator (QH)
Miss Rachel Aguilo
Principal Investigator (NMH)
Mr James Haddow
Principal Investigator (HUH)
Mr Salim Tayeh
Project Supervisor
Mr Charles Knowles
Lead R&D & Sponsor
Barking Havering & Redbridge University Hospitals NHS Trust
Lead R&D Director
Professor Jayanta Barua
Lead R&D Contact
Mr Ian Laskey
R&D Coordinator, Queen’s Hospital, Rom Valley Way, Romford,
Essex RM7 0AG
T: 01708 435306
F: 01708 435305
E: ian.laskey@bhrhospitals.nhs.uk
Barking, Havering & Redbridge University Hospitals NHS Trust (lead R&D and sponsor)
Hospitals involved
King George Hospital (KGH), Barley Lane, London IG3 8YB
Queen’s Hospital (QH), Rom Valley Way, Romford, Essex RM7 0AG
Principal Investigator (KGH)
Mr Wayne Chicken
Principal Investigator (QH)
Miss Rachel Aguilo
Site Supervisor (KGH)
Mr Sabu Jacob
R&D Contact
Mr Ian Laskey
R&D Coordinator, Queen’s Hospital, Rom Valley Way, Romford,
Essex RM7 0AG
T: 01708 435306
F: 01708 435305
E: ian.laskey@bhrhospitals.nhs.uk
North Middlesex University Hospital NHS Trust
Hospitals involved
North Middlesex University Hospital (NMUH), Sterling Way, London
N18 1QX
Principal Investigator
Mr James Haddow
Site Supervisor (KGH)
Mr Luke Meleagros
Local Collaborators
Mr Hussam Adwan
Dr Christine Gan
R&D Contact
Mr Steven Roberts
R&D Coordinator, North Middlesex University Hospital, Sterling Way,
London N18 1QX
T: 020 8887 2307
E: stephen.roberts@nmh.nhs.uk
Version 5.2p | 12/7/2010 | Page 11 of 24
SAS Pilot Protocol
Homerton University Hospital NHS Foundation Trust
Hospital involved
Homerton University Hospital (HUH), Homerton Row, London E9 6SR
Principal Investigator
Mr Salim Tayeh
Local Collaborator
Dr Miriam Adebibe
Site Supervisor
Mr Charles Knowles
R&D Contact
Chameli Uddin
R&D Administrator, Small Office, Blue Roof Homerton University
Hospital, Homerton Row, London E9 6SR
T: 020 8510 5501
F: 020 8510 7850
E: chameli.uddin@homerton.nhs.uk
Imperial College Healthcare NHS Trust
Hospital involved
St Mary’s Hospital (SMH), Praed Street, London W2 1NY
Principal Investigator
Ms Parveen Jayia
Site Supervisor
Mr Richard Gibbs
R&D Manager
Mr Richard Abbott
R&D Contact
Susana Murphy
Research Governance Administrator, R&D Department, Imperial
College Healthcare NHS Trust, St Mary’s Hospital, Mailbox 121,
Praed Street, London W2 1NY
T: 020 3312 6484
F: 020 3312 1529
E: susana.murphy@imperial.nhs.uk
Contacts Information
Name and post held
Contact information
Mr Charles Knowles
Senior Lecturer in Colorectal Surgery and Honorary
Colorectal Surgeon, Barts & the London NHS Trust
and Homerton University Hospital NHS Foundation
Trust
Academic Surgical Unit, 3rd Floor Alexandra
Wing, Royal London Hospital, Whitechapel,
London E1 1BB
T: 020 7882 8757
M: 07866 586766
F: 020 7377 7346
E: c.h.knowles@qmul.ac.uk
Dr Miriam Adebibe
CT3, General Surgery
Academic Unit of Medical & Surgical
Gastroenterology, Homerton University Hospital,
Homerton Row, London E9 6SR
T: 020 8510 7981
M: 07773 756836
E: elfinoli@aol.com
Mr Salim Tayeh
Senior Clinical Fellow, General Surgery
Academic Unit of Medical & Surgical
Gastroenterology, Homerton University Hospital,
Homerton Row, London E9 6SR
T: 020 8510 7981
M: 07867 895385
E: salimtayeh@hotmail.co.uk
Version 5.2p | 12/7/2010 | Page 12 of 24
SAS Pilot Protocol
Name and post held
Contact information
Mr Sabu Jacob
Consultant Vascular & General Surgeon
Department of General Surgery, King George
Hospital, Barley Lane, London IG3 8YB
T: 020 8970 8058
E: sabu.jacob@bhrhospitals.nhs.uk
Mr Wayne Chicken
SpR, General Surgery
Department of General Surgery, King George
Hospital, Barley Lane, London IG3 8YB
T: 020 8983 8000
E: dwchicken@googlemail.com
Dr Christine Gan
CT1, General Surgery
Department of General Surgery, North
Middlesex University Hospital, Sterling Way,
London N18 1QX
T: 020 8887 2000
E: christine.gan@doctors.org.uk
Mr Hussam Adwan
SpR, General Surgery
Department of General Surgery, North
Middlesex University Hospital, Sterling Way,
London N18 1QX
T: 020 8887 2000
M: 07810 774499
E: h.adwan@nhs.net
Mr James Haddow
Specialist Registrar, General Surgery
Department of Colorectal Surgery, North
Middlesex University Hospital, Sterling Way,
London N18 1QX
T: 020 8887 2000
M: 07788 723535
E: james.haddow@mac.com
Mr Luke Meleagros
Consultant Colorectal and Laparoscopic Surgeon,
General Surgery
Department of General Surgery, North
Middlesex University Hospital, Sterling Way,
London N18 1QX
T: 020 8887 2000
E: luke.meleagros@nmh.nhs.uk
Miss Rachel Aguilo
Specialist Registrar, General Surgery
Department of Surgery, Queen’s Hospital, Rom
Valley Way, Romford, Essex RM7 0AG
M: 01708 435000
E: rachelaguilo@doctors.org.uk
Mr Richard Gibbs
Consultant Vascular Surgeon
Department of Vascular Surgery, St Mary’s
Hospital, Praed Street, London W2 1NY
T: 020 7886 3726
F: 020 7886 2216
Ms Parveen Jayia
Core Surgical Trainee, Vascular Surgery
Department of Vascular Surgery, St Mary’s
Hospital, Praed Street, London W2 1NY
T: 020 7886 6528
E: parveenjayia@gmail.com
Version 5.2p | 12/7/2010 | Page 13 of 24
SAS Pilot Protocol
Authorship
The main author on the front of any paper, report, presentation or poster will be ‘London
Surgical Research Group’ (if presenting, the presenters are permitted to list their names
under this at the beginning). All authors will be individually listed at the end in the
following order (see the GALA trial for a good example5):
1. Writing committee: Chief investigator, co-writers, project supervisor, statistician
2. Principal investigators (in order of number of patients randomised from most to
fewest)
3. Local collaborators grouped by site (includes supervising consultants and other
researchers)
Version 5.2p | 12/7/2010 | Page 14 of 24
SAS Pilot Protocol
Appendix 1: Summary of data to be collected
Patient Details (to be erased before central collation)
1. Name
2. Hospital Number
3. Date of birth
Operation Details
4. Gender: M/F
5. ASA: 1 to 5
6. Operation date (to calculate age at operation in years)
7. Operation class: Minor / Intermediate / Major / Extensive
8. Operation type: Elective / Emergency
Operation Data
9. Estimated blood loss (EBL): ml
10. Lowest mean arterial pressure (MAP): mmHg
11. Lowest heart rate (HR): bpm
12. Presence of pathological arrhythmias: Y/N
Randomisation
13. Reference number
14. Date of randomisation
15. Allocated treatment group: Control / Intervention
Intervention Group
16. Surgical Apgar Score calculation
17. Outcome of actions based on score: Y/N
a. Admission to ITU/HDU previously planned
b. Accepted for ITU/HDU care
c. Increased monitoring on ward
d. No extra measures recommended
e. ITU not contacted and reason
f. Prophylactic/treatment antibiotics prescribed
g. Stress ulcer prophylaxis prescribed (e.g. PPI)
h. DVT prophylaxis prescribed
i. Handover Done
j. Twice daily reviews planned
30-day Follow-up Data
18. Date of review (to check minimum follow-up period)
19. Complications list, dates and Clavien grade: I to V +/- d
20. Primary admission to ITU/HDU: None / ITU / HDU
21. Primary admission to ITU/HDU length of stay: days
22. Secondary admission(s) to ITU/HDU: None / ITU / HDU
Version 5.2p | 12/7/2010 | Page 15 of 24
SAS Pilot Protocol
23. Secondary admission(s) to ITU/HDU total length of stay: days (sum total if more
than one readmission)
24. Therapeutic (>24 hours) antibiotics: Y/N
25. Total duration of therapeutic (>24hrs) antibiotics: days (sum total if more than one
course)
26. Number of additional operations under GA to treat complications
27. Date of discharge (to calculate overall length of stay in days)
28. Death within 30-days of operation: Y/N
29. Date of death (to calculate post-operative days)
Version 5.2p | 12/7/2010 | Page 16 of 24
SAS Pilot Protocol
Appendix 2: Major complication definitions and classification
NSQIP-defined6: Acute renal failure, bleeding requiring 4U or more of red blood cells
within 72 hours after surgery, cardiac arrest requiring CPR, coma of 24 hours or longer,
deep venous thrombosis, myocardial infarction, unplanned intubation, ventilator use for 48
hours or more, pneumonia, pulmonary embolism, stroke, wound disruption, deep or
organ-space surgical site infection, sepsis, septic shock, SIRS and vascular graft failure
(not included: superficial surgical site infection, urinary tract infection).
Clavien class III and greater7 (see table below)
Clavien Grade System
Grade
Definition
Grade I
Any deviation from the normal postoperative course without the need for
pharmacological treatment or surgical, endoscopic, and radiological interventions.
Allowed therapeutic regimens are drugs such as antiemetics, antipyretics, analgesics,
diuretics, electrolytes and physiotherapy.
This grade also includes wound infections opened at the bedside.
Grade II
Requiring pharmacological treatment with drugs other than such allowed for grade I
complications. Blood transfusions and total parenteral nutrition are also included.
Grade IIIa
Requiring surgical, endoscopic or radiological intervention not under general
anaesthetic
Grade IIIb
Requiring surgical, endoscopic or radiological intervention under general anaesthetic
Grade IVa
Life-threatening complication (including CNS complications)* requiring HDU/ITU
management of single organ dysfunction
Grade IVb
Life-threatening complication (including CNS complications)* requiring HDU/ITU
management of multi-organ dysfunction
Grade V
Death
Suffix “d”
Applicable if the complication is still present at the time of discharge
*Brain haemorrhage, ischaemic stroke, subarachnoidal bleeding, but excluding transient ischaemic
attacks. CNS, central nervous system; HDU, high dependency unit; ITU, intensive care unit.
Version 5.2p | 12/7/2010 | Page 17 of 24
SAS Pilot Protocol
Appendix 3: Guide to site implementation
The deadline for site setup is 1st November 2010.
The start date for data collection is 1st December 2010.
The following steps do not need to be completed in order, and if done concurrently, will
save a lot of time.
Initial steps
 Register with LSRG at http://groups.yahoo.com/group/lsrguk
 Download the protocol from files section on this website, read and decide if it is
suitable for your site
 Recruit and discuss project with a suitable consultant who will act as the site
supervisor
 Register with IRAS at https://www.myresearchproject.org.uk/
 Send IRAS username to chief investigator. The NHS/HSC R&D form and the SSI
form will then be transferred to your account.
 Send information to chief investigator listed in Table 5. Once this is done, you will
be sent back a patient pack (information sheet, consent form and proformas)
specific for your site.
Table 5. Information to be sent to the chief investigator.
Contact information
Send full names with titles, post held, department, address, telephone
and email for:
• Principal investigator
• Site supervisor
• Local collaborators (can be sent as and when recruited)
• R&D director
• R&D co-ordinator or contact
CVs
Send CVs for all researchers above who are involved (max 2 pages
each). If needed this can be easily generated on IRAS: complete the
CV in My Account section, click print and save PDF.
SSI form
(site specific
information)
An SSI form will be transferred to your IRAS account for completion.
Once completed, click print to generate a PDF and send this to the
chief investigator.
Trust information
Send the following info for customisation of patient pack:
• Trust letterhead in electronic format
• R&D co-ordinator or contact name
• R&D department address and direct telephone number
• PALS department direct telephone number
• Internal address where to send completed proformas
• Bleep and mobile number of principal investigator
Version 5.2p | 12/7/2010 | Page 18 of 24
SAS Pilot Protocol
Governance
 Register project at the site’s R&D office
 Complete SSI form (see Table 5)
 Complete necessary documents for local R&D office. They will give you a full list
of what they require, but they will include:
 Project protocol (available on LSRG website)
 Patient pack (will be customised to local trust and available on LSRG
website)
 NHS/HSC R&D form (transferred to your IRAS account)
 SSI form (transferred to your IRAS account and completed by you)
 Ethics letter (available on LSRG website)
 Researchers’ CVs
Local resources and IT
 Identify storage. Please find a lockable filing cabinet that is in a room that is locked
when unoccupied. This is to store all consent forms and proformas. Once the pilot
is completed the proformas can be destroyed and the consent forms store with
R&D.
 Liaise with IT and allocate secure server space to enable storage and access to the
project database and resources.
 Install Microsoft Access database, database instructions, link for randomisation
website and patient pack PDF (available on LSRG website).
 Test database following test instructions (available on LSRG website).
 Devise easy system for the storage and access of blank printed out patient packs
(these will be supplied pending funding decision).
 Ensure a reliable and easy system of returning of proformas to the principal
investigator after completion at the different stages: recruitment, end of operation
and review after 30-days (clinic or ward).
Promotion, recruitment and training
 Identify and recruit suitable consultant surgeons and their registrars. Please
consider the appropriateness of the consultant’s case-mix, the reliability of the
registrar, and the feasibility of them conducting the necessary steps during the
study. One-to-one discussions are probably more effective, but departmental
presentation may also be useful in increasing awareness amongst staff who are not
necessarily involved.
 Discuss the project with the anaesthetic department lead consultant to gain
support.
 Discuss with department manager and outline the schedule and impact on staff
activity. Please assure them that this will be minimal as each point of data collection
is during a current clinical activity and will not add significantly to workload, and
that your allocated research time is being used for this project.
 Please offer authorship as a carrot to anyone who is either actively taking part or
giving important support at department/trust level. This is a multicentre study and
therefore the number of people who will need to be involved is appropriately large.
Version 5.2p | 12/7/2010 | Page 19 of 24
SAS Pilot Protocol
 One month before data collection, train researchers on the protocol and use of the
information sheet, consent form and proformas. Handout a flowchart for easy
reference (available on LSRG website).
Data collection
 Ensure weekly collection of proformas.
 Maintain liaison with all researchers throughout the study to keep momentum.
 Input data into the database at weekly intervals. This should be done by the
principal investigator and core team only. Please do not give access to everyone, as
this will open the dataset to inconsistencies. Please do not leave inputting to the
end of the study.
 Audit incomplete records monthly (see database instructions available on LSRG
website) and chase missing proformas and patients who are lost-to-follow-up.
After data collection has finished
 Create anonomised dataset and send to chief investigator (see database instructions
available on LSRG website).
 Feedback on running of pilot, problems and solutions.
 Store all consent forms with R&D.
 Destroy all proformas.
 Delete the database after 1 year.
Version 5.2p | 12/7/2010 | Page 20 of 24
SAS Pilot Protocol
Project Documents
Document
Version/Ref
Date
Protocol
5.2p
07/12/2010
Flowchart
5.1p
28/10/2010
REC application form
44555/141132/1/802
08/04/2010
REC approval Letter
10/H0701/37
01/09/2010
R&D application form
44555/161507/14/252
28/10/2010
Peer review form
Patient Pack (containing participant
information sheet, consent form and
proformas)
BHR Data protection form
08/11/2010
3.0p
25/06/2010
15/01/2010
Version 5.2p | 12/7/2010 | Page 21 of 24
SAS Pilot Protocol
Version History
Version 5.2p 07/12/2010
Substantial amendments
Chief investigator changed
Non-substantial amendments
Funding information updated
Contact information updated
Version 5.1p 18/11/2010
Non-substantial amendments
New NHS Site Added
Contact information updated
Project documents section added
Flowchart corrected to show correct age for adults
Version 5.0p 05/08/2010
Substantial amendments
Inclusion criteria for capacity to consent clarified but not changed
Randomisation stage is now after the operation to prevent possible performance bias by
the surgeon or anaesthetist
Randomisation is now also stratified for hospital site to balance each patient group
Non-substantial amendments
Primary aims reworded but not changed
Consent forms to be filed in a separate confidential file and held secure in the R&D
department to comply with governance requirements
Ethics section added
Risks section added
Safety reporting section added
Costs and funding slightly adjusted and section expanded in more detail
Project management section added
Methods of disseminating findings section added
Project timeline section added
Authorship section added
Site information section added
Contact information section added
References added
Appendix 1 updated to show data collected in intervention group
Appendix 3: Guide to implementation added
Version 4.0p 25/02/2010
First submission for ethical approval.
Version 5.2p | 12/7/2010 | Page 22 of 24
SAS Pilot Protocol
Version 3.1p 01/01/2010
Draft version.
Version 5.2p | 12/7/2010 | Page 23 of 24
SAS Pilot Protocol
References
1
2
3
4
5
6
7
Chandra A et al. A review of risk scoring systems utilized in patients undergoing
gastrointestinal surgery. J Gastro Surg. 2009;13(8):1529-1538.
Gawande AA et al. An Apgar score for surgery. J Am Coll Surg. 2007;204(2):201-208.
Regenbogen SE et al. Utility of the Surgical Apgar Score validation in 4119 patients.
Arch Surg. 2009;144(1):30-36.
Prasad SM et al. Surgical apgar outcome score: perioperative risk assessment for radical
cystectomy. J Urol. 2009;181(3):1046-1053.
GALA Trial Collaborative Group. General anaesthesia versus local anaesthesia for
carotid surgery (GALA): a multicentre, randomized controlled trial. Lancet.
2008;372(9656):2132-42.
Khuri SF et al. The National Veterans Administration Surgical Risk Study: risk
adjustment for the comparative assessment of the quality of surgical care. J Am Coll
Surg. 1995;180(5):519-531.
Dindo D et al. Classification of surgical complications: a new proposal with evaluation
in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205-213.
Version 5.2p | 12/7/2010 | Page 24 of 24