Investigator Instructions

Research Study Title: SAS Pilot

Dear Colleague,

Thank you for taking the time to recruit your patient to this trial. Please make sure you have registered as an investigator on this study at so that you can access the randomization website and your name is included in the list of authors. Below are the steps required and a flowchart is on the next page. These proformas can also be downloaded at the website above.

  1. Identify a potential participant when you consent them for their operation. If they meet the inclusion criteria (see checklist on Registration Proforma) then explain the study to them. Give them the Participant Information Sheet. If possible, give them time before requesting their decision.
  2. Obtain consent and ask the patient to sign the Consent Form. (If they decline to participate record this on the Registration Proforma)
  3. Fill out the Registration Proforma and place the rest of the blank proformas in the notes.
  4. At the end of their operation fill out the Operation Data Proforma and then follow the instructions on how to randomize the patient on the website.
  5. For the intervention group only: proceed directly to the Scoring Proforma to calculate the Surgical Apgar Score.
  6. Then follow the instructions on the appropriate Action Proforma, based on the score you have just calculated. These actions are crucial to the success of the study so please try your hardest to complete.
  7. The 30-Day Outcome Proforma can be started at any time post-op so that all complications are recorded when they occur. The proforma must then be completed after at least 30 days. This would usually be during the first clinic visit, or can also be on the ward if still an inpatient. It does not need to happen at exactly 30 days, but do not collect data that refers to events after 30 days.

Best wishes,

Mr James Haddow, Principal Investigator

SAS Pilot Flowchart

SAS PilotInvestigator Instructions | Version 3.0p | 25/06/2010 | Page 1 of 2

Participant Information Sheet

Research Study Title: SAS Pilot

We would like to invite you to take part in a research study. Please take time to read the following information carefully. Talk to others about the study if you wish.

What is the SAS Pilot?

This is a mini-clinical trial that will study a new surgical score – the Surgical Apgar Score (SAS). Previous studies have shown that this score can predict the chance of problems happening within 30 days of surgery. However, we do not know if using this scorecan actually prevent problems by improving clinical practice. The purpose of this trial is to see if this is possible. The results of this trial may be definitive alone or guide the design of a much larger clinical trial. If the score is shown to be effective, it could lead to improved safety for all patients undergoing surgery.

Do I have to take part?

Participation is entirely voluntary. It is up to you to decide. We will describe the study and go through this information sheet. We will then ask you to sign a consent form to show you have agreed to take part. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive.

What is involved?

Your surgery will not change and will proceed as planned with your clinical team. After your surgery you will be managed in one of two ways.

One way will be to care for you in exactly the same way as if you were not participating in the trial. In other words, your care will be as per the current standards in your hospital using all the experience and resources we usually have available. We call this the control group.

The other way will be to care for you in the same way using all the clinical experience and resources we usually have available, with the only difference being that we will also use the score to help us decide if you need more attention and monitoring. We call this the intervention group.

Everything else to do with your progress and discharge after surgery will be unchanged. When you are next seen in the outpatient clinic as part of your routine follow-up, a member of your clinical team will record information on the outcome of your surgery and if you suffered any problems. This will finish your participation in the trial.

Will I be told which treatment group I am in?

Allocation to either the control or intervention groups is random. In order to make analysis as fair as possible, we are unable to reveal to you which one you have been allocated. If you are interested after the trial has finished, then you may contact your clinical team for this information.

Are there any experimental treatments or rationing?

No. This trial will not use any experimental treatments. If you are currently in another clinical trial, this trial will not interfere in any way. There will be no rationing or reduction in the care you receive as a result of this trial.

Are there any extra interviews or tests involved?

No. We will use clinical information that is gathered during and after your surgery during routine reviews. We will not need to perform tests (e.g. blood tests) for the purpose of this trial.

Could I come to harm because of this trial?

No. The most likely result after your surgery will either be standard or above standard.

Will my data be confidential?

Yes. We will follow ethical and legal practice and all information about you will be handled in the strictest confidence. Data containing personal details will be destroyed 1 year after the study has ended. Before analysis, your personal details will be removed so you cannot be identified. This anonymous data will be encrypted and kept secure for 10 years, and we may use it for other related research. Only members of the research team will have access to the data. The data will not be used or transferred to commercial organisations.

How can I be kept informed?

If you would like to be kept informed of the progress of the trial then you may sign up to an email newsletter by sending an email to . For individual information, please contact your clinical team who will be able to liaise with the local researcher.

What if there is a problem or I wish to withdraw?

If you have any concernsor complaints or you wish to withdraw, please ask to speak to one of the researchers who can be contacted through the hospital’s Research & Development Department on 020 8887 2307. If you prefer, you can contact the hospital’s Patient Advice and Liaison Service (PALS) on 020 8887 4172.

In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against the sponsor Barking, Havering and Redbridge Hospitals NHS Trust. The normal NHS complaints mechanisms will still be available to you (if appropriate).

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed and approved by East London 3 Research Ethics Committee.

How is this study funded?

The NHS is funding this study. There are no external sources of funding.

Further information and contact details

If you require further information please contact the hospital’s Research & Development (R&D) Department:

Stephen Roberts, R&D Department, North Middlesex University Hospital, Sterling Way N18 1QX

Tel: 020 8887 2307

The hospital’s principal investigator is Mr James Haddow and can be contacted at the Department of Surgery, North Middlesex University Hospital, Sterling Way N18 1QX

Tel: 020 8887 2000

The Lead R&D Department contact is:

Mr Ian Laskey, R&D Department, Queen’s Hospital, Rom Valley Way, Romford, Essex RM7 0AG

Tel: 01708435306

The chief investigator is Mr Sabu Jacob and can be contacted through the Lead R&D Department contact above.

The research group running this trial is called the London Surgical Research Group. You can find out more at

SAS PilotParticipant Information Sheet | Version 3.0p | 25/06/2010 | Page 1 of 4

Consent Form for Participation in Clinical Trial

Research Study Title: SAS Pilot

Participant Details (or please affix sticker)

Surname
First name
Date of Birth
Hospital No

Statement of ParticipantPlease initial box

I confirm that I have read and understood the information sheet (version 3.0p) for the SAS Pilot study. I have had the opportunity to consider the information ask questions and have had these answered satisfactorily. /
I understand that my participation isvoluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected. /
I understand that authorised researchers from this study may look at relevant sections of my medical notes and data collected during the study. I give permission for these individuals to have access to my records. I understand that all data will be confidential and anonymous and destroyed at the end of the study. /
I agree to take part in the SAS Pilot study. /
Participant’s signature / Print name / Date
Researcher’s signature / Print name / Date

DO NOT PUT IN THE NOTES – Please send this consent form to:

Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535

SAS PilotConsent Form | Version 3.0p | 25/06/2010 | Page 1 of 2

SAS Pilot: Registration
To be completed by surgeon beforetheoperation / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Eligibility & Consent Checklist
Eligibility Criteria
(all must apply) / ☐ Age 18 years or older
☐ General surgery or vascular operation
☐ Emergency or elective surgery
☐ Routine follow-up will be required
☐ Patient has capacity to consent
Information Sheet / ☐ Must be given to patient and explained
Consent / ☐ Form signed by patient
☐ Patient declined(please still record on database)
Signature / Print Name / Bleep / Ext
Instructions
DO NOT PUT IN THE NOTES – Please send this completed sheet and the consent form to:
Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535
Keep the remaining proformas in the front of the notes.
The next proforma should be completed at the end of the operation.
SAS Pilot: Operation Data
To be completed by surgeon attheend of operation / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Operation Details
Operation Date
Operation Class / ☐ Minor☐ Major
☐ Intermediate☐ Extensive
Operation Type / ☐ Elective ☐ Emergency
Patient Gender / ☐ Male ☐ Female
ASA Grade (1 to 5)
Data
(ask the anaesthetist to read out the values to you – do not read them yourself)
Estimated Blood Loss (ml)
Lowest MAP (mmHg)
(MAP = Diastolic + 1/3 x (Systolic – Diastolic)
Lowest Heart Rate (bpm)
Pathological bradyarrhythmia / ☐ Did not occur ☐ Occurred
(includes sinus arrest, AV block or dissociation, junctional or ventricular escape rhythms and asystole)
Randomisation
(after the above data is collected registerpatient at )
ALEA Patient Number
Allocated Treatment Group / ☐ Control ☐ Intervention
 / 
Next step / Discard scoring and action proformas. The next step will be the outcome proforma. / Continue on to the scoring proforma
Signature / Print Name / Bleep / Ext
Instructions
DO NOT PUT IN THE NOTES – Please send this completed sheet to:
Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535
SAS Pilot: Scoring
Only for patients in intervention group
To be completed by surgeon at the end of operation / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Surgical Apgar Score (circle each score and add up the points)
0 / 1 / 2 / 3 / 4 / Score
Estimated Blood Loss (ml) / >1000 / 601-1000 / 101-600 / ≤100
Lowest MAP (mmHg) / <40 / 40-54 / 55-69 / ≥70
Lowest Heart Rate (bpm) / 85* / 76-85 / 66-75 / 56-65 / ≤55*
*pathological bradyarrhythmia scores 0
Surgical Apgar Score (Total)
Signature / Print Name / Bleep / Ext
Instructions
DO NOT PUT IN THE NOTES – Please send this completed sheet to:
Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535
Please now complete the appropriate action form (either high risk, average risk or low risk) based on the score you calculated and discard the unused action forms.
SAS Pilot: Action for
HIGH Risk Score (0-4)
Only for patients in intervention group
To be completed by surgeon at the end of operation / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Score
Surgical Apgar Score is:
☐ Score 0-4 (if not see other sheets)

Patient is at HIGH RISK (60%) of major complications. Please do the following:

Action / Outcome (tick)
1. Discuss with ITU/HDU and request a review to consider admission / ☐ Admission to ITU/HDU previously planned
☐ Accepted for ITU/HDU care
☐ Increased monitoring on ward
☐ No extra measures recommended
☐ ITU not contacted – state reason:
2. Prescribe antibiotics, stress ulcer and DVT prophylaxis if considered beneficial / ☐ Prophylactic/treatment antibiotics prescribed
☐ Stress ulcer prophylaxis prescribed (eg PPI)
☐ DVT prophylaxis prescribed
☐ None necessary
3. Handover to surgical colleague to review observations, urine output and pain after 4 and 8 hours / ☐ Handover done
☐ Not done
4. Plan twice daily reviews for 2 days / ☐ Twice daily reviews planned
☐ Not done
Signature / Print Name / Bleep / Ext
Instructions
Please secure this form in the FRONT OF THE NOTES UNTIL DISCHARGE and then send completed sheet to:
Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535
Discard the unused action forms.
The next form should be completed after 30 days at next outpatient appointment or ward review.
SAS Pilot: Action for
AVERAGE Risk Score (5-8)
Only for patients in intervention group
To be completed by surgeon at the end of operation / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Score
Surgical Apgar Score is:
☐ Score 5-8 (if not see other sheets)

Patient is at AVERAGE RISK (15%) of major complications. Please do the following:

Action / Outcome (tick)
1. Prescribe antibiotics, stress ulcer and DVT prophylaxis if considered beneficial / ☐ Prophylactic/treatment antibiotics prescribed
☐ Stress ulcer prophylaxis prescribed (eg PPI)
☐ DVT prophylaxis prescribed
☐ None necessary
2. Handover to surgical colleague to review observations, urine output and pain after 4 and 8 hours / ☐ Handover done
☐ Not done
3. Plan twice daily reviews for 2 days / ☐ Twice daily reviews planned
☐ Not done
Signature / Print Name / Bleep / Ext
Instructions
Please secure this form in the FRONT OF THE NOTES UNTIL DISCHARGE and then send completed sheet to:
Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535
Discard the unused action forms.
The next form should be completed after 30 days at next outpatient appointment or ward review.
SAS Pilot: Action for
LOW Risk Score (9-10)
Only for patients in intervention group
To be completed by surgeon at the end of operation / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Score
Surgical Apgar Score is:
☐ Score 9-10 (if not see other sheets)

Patient is at LOW RISK (5%) of major complications. Please manage as per standard clinical care.

Signature / Print Name / Bleep / Ext
Instructions
Please secure this form in the FRONT OF THE NOTES UNTIL DISCHARGE and then send completed sheet to:
Mr James Haddow, SpR, Department of Surgery, North Middlesex University Hospital, Bleep: 244, Mobile: 07788 723535
Discard the unused action forms.
The next form should be completed after 30 days at next outpatient appointment or ward review.
SAS Pilot: 30-Day Outcome
Can be started on discharge
To be completed by surgeon after30 days atnext outpatient appointmentor ward review / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Events only within 30-days of operation
Date of this review
N01 Bleeding requiring 4+U blood in first 72 hours / ☐ No ☐ Yes
N02 Surgical site infection superficial / ☐ No ☐ Yes
N03 Surgical site infection deep or organ space / ☐ No ☐ Yes
N04 Wound disruption / ☐ No ☐ Yes
N05 Cardiac arrest requiring CPR / ☐ No ☐ Yes
N06 Myocardial infarction / ☐ No ☐ Yes
N07 Deep vein thrombosis / ☐ No ☐ Yes
N08 Pulmonary embolism / ☐ No ☐ Yes
N09 Pneumonia / ☐ No ☐ Yes
N10 Unplanned intubation / ☐ No ☐ Yes
N11 Ventilator use for 48+ hours / ☐ No ☐ Yes
N12 Coma of 24+ hours / ☐ No ☐ Yes
N13 Stroke / ☐ No ☐ Yes
N14 SIRS / ☐ No ☐ Yes
N15 Sepsis / ☐ No ☐ Yes
N16 Septic shock / ☐ No ☐ Yes
N17 Acute renal failure / ☐ No ☐ Yes
N18 Vascular graft failure / ☐ No ☐ Yes
N19 Urinary retention / ☐ No ☐ Yes

PROFORMA CONTINUED ON NEXT PAGE…

(three page proforma)

SAS Pilot: 30-Day Outcome
Can be started on discharge
To be completed by surgeon after30 days atnext outpatient appointmentor ward review / Patient Details (affix sticker)
Surname......
First Name......
Date of Birth......
Hospital Number......
Events only within 30-days of operation(continue on back if necessary)
Date / List allother complications / Clavien Grade / Suffix “d”
☐ No ☐ Yes
☐ No ☐ Yes
☐ No ☐ Yes
☐ No ☐ Yes
☐ No ☐ Yes
☐ No ☐ Yes

PROFORMA CONTINUED ON NEXT PAGE…

(three page proforma)

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.