Student Audit and Research in Surgery

Endorsed by the Renal Association

Outcomes after kidney injury in surgery

The OAKS study
A student-led audit of acute kidney injury following major gastrointestinal surgery

Study protocol v6.0

September 2015

OAKS has been endorsed by the Renal Association

Key Study Dates:

Lead meeting:
National meeting:

Tue 7th July 2015, RCS(Ed), Birmingham

Wed 16th September 2015, RCS(Eng), London

Audit registration period:

Begins 13th July 2015

Data collection periods:

Begin 23rd Sept 2015

Follow-up periods:

End 18th December 2015

1
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Endorsed by the Renal Association

Table of Contents

TABLE OF CONTENTS

STARSURG STEERING COMMITTEE

EXPERT ADVISORY GROUP

PROJECT TIMELINE

ABOUT STARSURG

INTRODUCTION

AUDIT GOLD STANDARDS

METHODS

APPENDIX A: SUMMARY OF DATA FIELDS

18

APPENDIX B: DATA DICTIONARY

19

APPENDIX C: CENTRE QUESTIONNAIRE

24

APPENDIX D: OPCS-4.7 PROCEDURE CODES

25

APPENDIX E: ICD-10 DIAGNOSIS CODES

27

APPENDIX F: CLAVIEN-DINDO CLASSIFICATION SYSTEM

28

APPENDIX G: KEY STEPS FOR SUCCESSFUL INCLUSION OF YOUR CENTRE

30

APPENDIX H: ETHICS WAIVER

32

APPENDIX I: REFERENCES

33

Further additional resources can be found at the OAKS study online hub:
http://www.starsurg.org/project

2
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Endorsed by the Renal Association

STARSurg Steering Committee

Michael Bath

Medical Student

Leicester

Academic Clinical Lecturer in Surgery

Birmingham

Medical Student

Bristol

Medical Student

Sheffield

General Surgery Registrar

London

Foundation Year 2

Cardiff

Medical Student

London

Consultant Surgeon & Senior Lecturer

Edinburgh

Foundation Year 1

Warwick

Medical Student

Glasgow

Medical Student

Dublin

Medical Student

Liverpool

Academic Clinical Fellow in Surgery

Birmingham

Twitter: @MikeFBath

Aneel Bhangu
Twitter: @aneelbhangu

Henry Claireaux
Twitter: @harryclax

Tom Drake
Twitter @tom_drake1

Edward Fitzgerald
Twitter: @DrEdFitzgerald

James Glasbey
Twitter: @DrJamesGlasbey

Buket Gundogan
Ewen Harrison
Twitter: @ewenharrison

Chetan Khatri
Twitter: @ChetanKhatri2

Nicholas Kong
Twitter: @KongChiaYew

Lisa McNamee
Twitter: @Lisa_Mcnamee

Midhun Mohan
Twitter: @midhunmohan1991

Dmitri Nepogodiev
Twitter: @dnepo

Expert Advisory Group

Nish Arul

Renal-ICM Specialist Registrar, London

Fiona Duthie

Renal Medicine Clinical Research Fellow

University of Edinburgh

John Prowle

Consultant in Intensive Care & Renal Medicine

Barts Health NHS Trust, London

Toby Richards

Senior Lecturer in Surgery

University College London, London

Mark Thomas

Consultant Nephrologist
Heart of England NHS Trust, Birmingham

3
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Endorsed by the Renal Association

Project timeline
July 7, 2015

STARSurg AGM, RCSEd centre in Birmingham.

OAKS protocol discussion.

Mid July onwards

Local leads co-ordinate formation of mini-teams.

Audit is registered at each participating centre.

Sept 16, 2015

National STARSurg meeting at RCSEng, London.

OAKS protocol discussion.

Sept 24, 2015

European student session at the European Society of

Coloproctology Meeting in Dublin.

Sept 23 Oct 7

Data collection period 1 (30-day follow-up ends Nov 6).

Oct 7 Oct 21

Data collection period 2 (30-day follow-up ends Nov 20).

Oct 21 Nov 4

Data collection period 3 (30-day follow-up ends Dec 4).

Nov 4 Nov 18

Data collection period 4 (30-day follow-up ends Dec 18).

Dec 4, 2015

Preliminary results presented at National Research

Collaborative Meeting in Sheffield.

Jan 31, 2016

REDCap database locked, final data submission deadline

March 18, 2016

STARSurg national meeting, at Association of Surgeons in

Training (ASiT) Conference in Liverpool, with OAKS debrief
and OAKS-II project planning.

Jan 31, 2017

Submission deadline for 1-year follow up data. This data will

be collected by OAKS-II collaborators.

4
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Endorsed by the Renal Association

About STARSurg
STARSurg was founded in 2013 to empower students to participate in high quality
academic projects, forming links with supervising junior doctors and consultants.
Students contribute data to national studies whilst gaining an understanding of clinical
academia, audit and research methodology, and ethical considerations in research1.
The collaborative trainee-led model for snapshot audit has been pioneered in the
UK, originally developed as regional networks of surgical registrars. These networks
have delivered major multicentre projects including cohort studies and multicentre
randomised controlled trials. The background to these has previously been described
in the Lancet2. Our authorship policy designates PubMed-citable co-authorship to all
collaborators. An example of this can be seen here:
ncbi.nlm.nih.gov/pubmed/25091299
Our first study saw 258 student collaborators representing 31 UK medical schools
collaborate to collect outcomes data on patients undergoing gastrointestinal
resection. Over 1500 patients across 109 UK hospitals were included. The results
were published in the British Journal of Surgery, a world top 5 surgical journal3.
STARSurgs second annual study examined the role of obesity in post-operative
complications4. In this study, 1,200 collaborators across 163 UK and Irish centres
collected data on over 9,000 patients undergoing major gastrointestinal and
hepatobiliary surgery.
STARSurg is run by the SURG Foundation, a UK registered charity. The committee
and advisers give their time to the charity for free, but we need your help to meet the
costs of our 2015 program. You can support the Foundation here:
givey.com/SURG_Foundation

5
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Endorsed by the Renal Association

Introduction
The National Confidential Enquiry into Patient Outcome and Death Adding Insult to
Injury (2009) report recommended that predictable and avoidable acute kidney injury
(AKI) should never occur. Post-operative AKI has previously been associated with
increased morbidity, mortality and costs in intra-abdominal surgery5-6.
Despite the recognition of AKI as a potentially modifiable driver of post-operative
morbidity, there is a lack of evidence regarding AKI following gastrointestinal and liver
surgery. There is limited high quality data on the incidence of post-operative AKI in
general surgery. Whilst pilot STARSurg data from one centre identified a 15.7%
(14/89) AKI rate in gastrointestinal patients, other studies estimate rates of 122%5-7.
However, many of these studies report heterogeneous outcome measures and have
significantly flawed study designs, limiting clinical applicability.
A high-quality, prospective audit with precise outcome reporting is needed. The
OAKS study aims to quantify the incidence of AKI in patients undergoing major
gastrointestinal and liver surgery and define the morbidity and mortality associated
with this. Exploring potential risk factors for the development of post-operative AKI will
identify potential targets for service improvement prior to re-audit.

6
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

Audit Gold Standards

Primary Audit Standards
(1)

Serum creatinine should be

measured pre-operatively.

NICE Clinical Guideline 3

All patients undergoing grade 4 (major +) surgery are recommended to have pre-operative renal
function tested.
NICE Clinical Guideline 169
1.1.8 Assess the risk of acute kidney injury in adults before surgery.
NCEPOD 2009: Adding Insult to Injury
Principal recommendation: All patients admitted as an emergency should have their electrolytes
checked routinely on admission.

(2)

Serum creatinine should be

measured post-operatively.

NICE Clinical Guideline 169

1.3.2 Monitor serum creatinine regularly in all adults at risk of acute kidney injury.
NICE Clinical Guideline 174
1.2.4 All patients continuing to have IV fluids need regular monitoring. This should initially include at
least daily reassessments urea, creatinine and electrolytes.
NCEPOD 2009: Adding Insult to Injury
Principal recommendation: All patients admitted as an emergency should have their electrolytes
checked routinely on admission and appropriately thereafter.

Secondary Audit Standard

(1)

Acute kidney injury should be

detected and recognised from
changes in creatinine.

NHS England Patient Safety Alert: Standardising the early identification of Acute Kidney Injury
(NHS/PSA/D/2014/010, 2014)
This directive introduced a National Algorithm for Detecting Acute Kidney Injury. It superseded earlier,
similar guidance in NICE Clinical Guideline 169 (1.3.1)

7
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

Methods
01
Summary
A mini-team of up to two medical students and one junior doctor at each
participating centre will prospectively collect data over a continuous 14-day
period on consecutive patients undergoing major gastrointestinal and liver
surgery. All mini-teams should be supervised by a consultant. Patients will be
followed up at one year by OAKS-II collaborators.
02
Study aims
Primary Aim
To audit adherence to guidelines requiring assessment of renal function before
and after major gastrointestinal and liver surgery.
Secondary Aims
(i) To determine the incidence of acute kidney injury following major
gastrointestinal and liver surgery.
(ii) To measure morbidity associated with post-operative acute kidney injury
(iii) To identify factors associated with post-operative acute kidney injury.
03
Project Timeline
The overall patient inclusion period will be Wednesday 23rd September 2015 to
Wednesday 18th November 2015. Each mini-team will collect data over a 14day, consecutive period. Data can be collected over any consecutive 14 days
during this period; however the following periods are recommended:
Period 1: 0800 Wednesday 23rd Sept to 0759 Wednesday 7th Oct.
Period 2: 0800 Wednesday 7th Oct to 0759 Wednesday 21st Oct.
Period 3: 0800 Wednesday 21st Oct to 0759 Wednesday 4th Nov.
Period 4: 0800 Wednesday 4th Nov to 0759 Wednesday 18th Nov.
Patients should be included if their operation started (defined as knife-to-skin
time) within the time period during which you are collecting data.

Up to 4 teams of students can participate at each centre, each

collecting data during a distinct two-week period to avoid overlap.

04
OAKS: A Closed Loop Audit
OAKS will be a closed loop audit over two years (figure 1). Following
dissemination of the audits findings at local governance meetings and national
surgical congresses, post-audit interventions will be planned at a national
STARSurg meeting. These will be implemented locally prior to re-audit in
8
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

autumn 2016. Data in the re-audit phase (OAKS-II) will be collected by

different mini-teams to those participating in the initial audit in autumn 2015.

Figure 1: Timeline of the OAKS closed loop audit

Detailed
guidance for
centres is
available in
Appendix F

05
Centres
Any hospital that performs gastrointestinal or liver surgery may
participate.
All participating centres are required to register the OAKS study
according to local regulations. Evidence of successful registration
should be sent to their universitys local lead prior to commencement of
data collection.
Following conclusion of the OAKS study, it is a requirement of
participation that mini-teams at each centre should present the audit
findings to their hospitals surgery and audit departments.

Providing feedback on the audits findings to your departments

clinicians is an essential step in the audit loop. Presenting local
results will help collaborators develop analytical and presentation
skills and will boost their CVs.

06
Inclusion & exclusion criteria

You should collect data on consecutive patients operated at your

centre during the data collection period. This means that all
eligible patients should be included.

Strategies to identify consecutive patients could include:

Daily review of elective theatre lists.
Daily review of handover sheets/ emergency admission and ward lists.
Daily review of theatre logbooks (both elective and emergency).
9
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

Inclusion criteria
Summary:

All
consecutive
adult
patients
undergoing
gastrointestinal resection / anastomosis or liver
resection should be included.

Age:

Aged 18 years or above

Urgency:

Elective or emergency procedures.

Technique:

Open, robotic, laparoscopic, laparoscopicallyassisted, or laparoscopic converted to open

procedures.

Returns to theatre:

Each individual patient should only be included in the

study once. Patients returning to theatre due to
complications following earlier surgery can be
included, as long as their indexed procedure has not
already been included in the OAKS dataset.

Included procedures:

Include
procedures
with
gastrointestinal
hepatobiliary pathology as the primary indication:
Any gastrointestinal resection.

A complete list
of included
procedure is
available in
Annex C

or

GI resection is defined as complete transection and removal of a

segment of the oesophagus, stomach, small bowel, colon or
rectum. Appendicectomy is not included. Resection following
trauma is included. Also included is Whipples procedure
(pancreaticoduodenectomy).

Any liver resection.

Reversal of ileostomy or colostomy.
Exclusion criteria
Previous kidney transplant
Regular renal-replacement pre-operatively
Excluded procedures:
Appendicectomy.
Cholecystectomy.
Hernia repair - Simple hernia repairs should not be included, but hernia

repair with bowel resection should be included.

Primarily urological procedure - e.g. ileal conduit.
Primarily gynaecological procedure - e.g. Hartmanns during surgery
for ovarian cancer.
Primarily vascular procedure - e.g. bowel resection during AAA repair.
Emergency laparotomy with bowel resection for mesenteric ischaemia should
be included.

Transplant surgery
10

collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

A full list of
required data
fields is in
Appendix A

Audit endorsed by the Renal Association

07
Covariates
Data will be collected on confounding factors to permit accurate risk
adjustment of outcomes. This will include the following pre-operative indices:
The American Society of Anaesthesiologists (ASA) score.
The Revised Cardiac Risk Index (RCRI)8 and smoking history.
08
Outcome Measures and Follow-up
Primary outcome measure
Incidence of acute kidney injury within 7 days of surgery. AKI will be identified
according to the National Algorithm for Detecting Acute Kidney Injury9.

See Appendix
F for a detailed
explanation of
the ClavienDindo scale
explanation

Secondary outcome measures

Incidence of acute kidney injury within 48 hours of surgery.
Persistent renal dysfunction at 30 days, or point of discharge, defined
as an increase in baseline Chronic Kidney Disease (CKD) stage.
30-day adverse event rate, measured using the Clavien-Dindo scale10.
Collaborators will not be required to identify patients with AKI or CKD. The
national data analysis team will calculate eGFR based on creatinine, age,
gender, ethnicity data submitted by collaborators. They will run algorithms to
identify AKI and CKD based on creatinine and calculated eGFR values
Strategies for identifying complications in the follow-up period include:
Regularly reviewing patient notes to identify in-hospital complications.
Reviewing clinic notes and clinic letters, if seen in clinic by 30 days.
Checking electronic systems and handover lists for re-admissions.
Checking for A&E re-attendances.
If case notes are reviewed shortly prior to discharge they do not be need
to be requested/retrieved again for follow-up at 30-days, but do check
electronic records for discharge letters, clinic letters, re-admissions.
Long term follow-up
To investigate whether post-operative AKI is associated with long-term renal
dysfunction, long term follow-up data will be collected in January 2017 by
OAKS-II collaborators. Long term outcomes will include:
Persistent renal dysfunction at 1 year, defined as an increase in
baseline Chronic Kidney Disease (CKD) stage, evidenced by two blood
tests at least 3 months apart. To identify patients fulfilling these criteria,
the lowest creatinine values measured at 9-12 and at 12-15 months
post-op will be recorded.
Regular renal replacement therapy at 1 year.
Mortality at 1 year.

Prior to collecting data, please complete the mandatory AKI and

Clavien-Dindo e-learning modules available from the OAKS
project online hub: http://www.starsurg.org/project

11

collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

A complete list
of data fields
and definitions
is provided in
Appendix A &
Appendix B

A guide to
using REDCap
can be found at
the OAKS
online hub

Printable data
proformas are
available from
the OAKS
online hub

Audit endorsed by the Renal Association

09
Dataset
Data domains that relate to the patient, operation, operative method and
postoperative period will be collected. Without adjusting for pre-operative risk,
it is likely that any findings would be biased. In addition consultants will
complete a centre questionnaire (Appendix C). Data will not be analysed at an
identifiable surgeon-level or centre-level.
10
Data Collation
Data will be collected and stored online through a secure server running the
Research Electronic Data Capture (REDCap) web application19. REDCap
allows collaborators to enter and store data in a secure system. Collaborators
will be given secure REDCap project server login details, allowing secure data
storage on the REDCap system. No patient identifiable information will be
uploaded or stored on the REDCap database without explicit permission from
the trusts Caldicott Guardian. Collaborators may wish to first record data on a
paper version of the data collection pro-forma. Paper copies of any data should
be destroyed as confidential waste within the centre once uploaded to
REDCap.
Facilitating follow-up
An important aim of OAKS is to audit long-term outcomes following AKI. This
will enable resources to be appropriately prioritised in the future to combat AKI.
In order to enter follow-up data at 1-year, it must be possible to link REDCap
records to patient records on hospital data systems (e.g. pathology results
systems). There are 3 methods of enabling this (listed in order of preference):
(i) Uploading the patients NHS number on to the REDCap system.
REDCap allows secure storage and NHS numbers will not be available
to the data analysis team. Collaborators must have Caldicott
Guardian approval prior to uploading NHS numbers.
(ii) The supervising consultant can email a password protected
spreadsheet containing a look-up table. This should cross-reference the
automatically generated REDCap ID number for each patient against
their NHS number. This data must be sent from an NHS email account
to our NHS email account (available upon request).
(iii) The look-up table (as described above) can be securely stored on NHS
computers by both audit office staff and the supervising consultant. If
you opt for this option, the audit office should confirm to us receipt of
the lookup table and that they will store this until needed for follow-up.

Detailed advice
on audit
registration can
be found in
Appendix G

11
Local Project Registration & Data Governance
OAKS should be registered as clinical audit. It is the responsibility of the local
mini-team at each site to identify a local consultant surgeon to supervise them
and ensure that OAKS is registered appropriately.
12
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

Confirmation that ethical review is not required for OAKS is available in

Appendix H. Examples of audit registration forms can be found at the online
project hub. When registering OAKS as a clinical audit you can emphasis that:
All data collected will measure current practice.
No changes to normal patient pathways/ treatment will be made.
OAKS is a national audit.
In addition collaborators in the UK should seek their trusts Caldicott
Guardians permission to submit data to the REDCap system. No data should
be uploaded to REDCap prior to written approval from the Caldicott Guardian.
Collaborators should explicitly ask for permission to upload NHS numbers, if
they wish to do this.
All data should be handled in accordance with the Surgical Research Gateway
(SuRG) Foundation Data Governance Code of Conduct. This document sets
out comprehensive guidelines on the management of data through all stages of
the project. All collaborators will be asked to agree to abide by this Code prior
to participating in OAKS.

Collaborators should complete the mandatory data governance

e-learning module which will be made available on the OAKS
project online hub: http://www.starsurg.org/project

REDCap accounts will not be issued until evidence is sent to your universitys
local lead that the following approvals are in place at your centre:
(i)
Successful registration of OAKS with the audit department.
(ii)
Caldicott Guardian permission for data to be submitted to REDCap.
For your local
leads contact
details see the
STARSurg
website

You must have confirmation of successful audit registration prior

to commencing data collection. If you encounter difficulties with
registering the study, seek advice from your supervising
consultant, your local lead, or the STARSurg steering committee.

12
Quality assurance
Protocol
This protocol was written with guidance from an expert cross-speciality
advisory group. The protocol subsequently underwent peer review by 21
STARSurg local leads at a dedicated meeting at the Royal College of
Surgeons of Edinburgh, Birmingham Centre on 7th July 2015. Feedback
from the day was used to refine the audit standards and study protocol.
Collaborator meetings
The protocol will be interactively presented and explained in detail at a
national collaborator meeting hosted by the Royal College of Surgeons of
England on 16th September 2015, attended by collaborators from across
the UK & Ireland.
13
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

For further
information
about miniteams, see
section 13

Audit endorsed by the Renal Association

Local leads are encouraged to hold local meetings with collaborating teams
at their medical school to brief them on the protocol.
E-learning online modules
To ensure collaborators understand the study topic (AKI), inclusion criteria,
application of the Clavien-Dindo classification and the principles of data
governance, they will all be asked to complete a series of online e-learning
modules (pass mark is 100%) prior to starting data collection (online at:
http://www.starsurg.org/project).
Mini-teams
Although many collaborators participating in the study will be medical
students, each team must include at least one qualified doctor to closely
supervise the students. The students will additionally be supervised by a
consultant surgeon at each site.
Pilot
In order to overcome a learning curve in identifying patients for inclusion,
data collection and using REDCap, participating centres may pilot patient
identification and the initial stages of data collection for one day in the
week leading up to their data collection start date. Any problems
encountered must be addressed by discussion with the steering committee.

Twitter:
@STARSurgUK

Twitter feedback sessions

Throughout the data collection period, the steering committee group will
hold weekly Twitter question and answer sessions, giving the opportunity
for collaborators to clarify any uncertainties regarding the protocol. A
summary of frequently asked questions will be distributed to all
collaborators following each Twitter session, providing real-time feedback.
Data completeness
Following data collection, only data sets with >95% data completeness will
be accepted for pooled national analysis. To emphasise the importance of
data completeness to collaborators, centres with >5% missing data points
will be excluded from the study and collaborators from those centres
withdrawn from the published list of citable collaborators.
Validation
At each participating medical school, the local lead will identify a
collaborator not involved in data collection to act as an independent
validator. The validator should be a final year student or a qualified doctor.
The validator will select a 2-week study period at a local centre to validate
all patients included during that period. A minimum of twelve patients must
have been included during that study period. Data validation will occur
following completion of data collection (including follow-up) by the miniteam at that centre. After completing validation, the validator will send a
summary of how many records were reviewed and error rates identified to
the steering committee.

14
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

Case ascertainment
The validator will independently identify all patients eligible for inclusion
over one 2-week study period at one local centre. The target for case
ascertainment is >95%.
Data collection
The validator will independently collect data for 12 key data fields relating
to risk-adjustment and outcome measures (see Appendix A). Any conflicts
with the data originally submitted by the relevant mini-team will be resolved
by discussion between the validator and the mini-team. The target for
accuracy of collected data is >98%.
13
Project team structure
Medical students will take the lead in disseminating and delivering this study,
which is supported by a collaboration of medical students, foundation doctors,
surgical trainees and consultant surgeons (figure 2):

Figure 2: STARSurg Mini-Team Structure, Roles and Responsibilities.

See page 3 for
steering
committee
details.

Steering Committee: a core group of medical students and supervising

surgical trainees and consultant responsible for protocol design, data
handling, analysis and drafting of the paper. The Steering Committee
are responsible for use of data resulting from the project.

For local leads

contact details
see the
STARSurg
website.

Local leads: a network of medical students across all medical schools.

o Responsible for co-coordinating mini-teams at local hospitals.
o Act as a link between mini-teams and the steering committee.
They are the first point of contact for local collaborators.
15

collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

o Ensure audit outcomes are reported back to the local audit

offices and clinical teams.

Mini-teams: a team of three people responsible for data collection over

a specific 2-week period at a particular centre.
o A mini-team is formed by a medical student collaborating with a
qualified doctor (FY1 to consultant grade). An additional student
or doctor makes the mini-team up to three people.
o In exceptional circumstances where local teams anticipate a very
high volume of patients being eligible for inclusion in OAKS, they
may contact the steering committee for permission to add an
additional person to their mini-team. Any increase in the miniteam must be agreed in advance with the steering committee.
o Junior doctors must either access all the blood tests necessary
to complete OAKS or ensure that students are granted access to
pathology system to access blood test results.
o Each mini-team will work with their local lead to ensure that the
audit results are reported back to their audit office/ clinical teams.

Consultants: each mini-team must be supervised by a consultant

surgeon. The consultant sponsors registration of the audit and ensures
collaborators act in accordance within governance guidelines. They
should also facilitate presentation of local audit results and support
appropriate post-audit interventions.

14
Authorship
Mini-team collaborators, supervising consultants, data validators, local leads
and steering committee will be eligible for PubMed-citable co-authorship.
Mini-teams
A maximum of three (typically 2 students and 1 doctor) collaborators per 14day data collection/ follow-up period will be listed as PubMed citable authors,
unless an increase in the mini-team is agreed in advance with the steering
committee. Independent validators at each site are also eligible for authorship.
Each mini-team collaborator should participate in registering the audit,
identifying patients, collecting data and follow-up, ensuring >95%
completeness and >98% accuracy targets are met. Centres with >5% missing
data will be excluded from analysis and the contributing mini-team will be
removed from the authorship list.
Consultants
In line with International Committee of Medical Journal Editors authorship
guidelines (http://www.icmje.org/), one consultant per centre is eligible for
collaborative PubMed citable co-authorship if they meet the following criteria:
(i) Supports local audit registration.
16
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

(ii) Circulates information about the audit and the audit protocol to
consultant colleagues.
(iii) Completes and returns the brief question centre questionnaire.
(iv) Facilitates presentation of local audit results at a departmental audit
meeting.
(v) Completes workplace-based assessments for students or trainees
(ePortfolio/ISCP), if asked.
(vi) Ensures mini-teams have agreed a safe means of facilitating 1-year
follow-up with the audit office and Caldicott Guardian (see section 10).
Local leads
To qualify for authorship, local leads must recruit at least two mini-teams at
each centre where students from their medical school have surgical
placements.

17
collaborate@starsurg.org
www.STARSurg.org

Student Audit and Research in Surgery

Audit endorsed by the Renal Association

Appendix A: Summary of data fields

Asterisks indicate data fields included in data accuracy validation.
1
2
3
4
5
6
7
8
9
10
11
12

*
*

13
14
15
16
17
18

*
*

Patient age
Patient gender
Patient ethnicity
ASA grade
History of ischaemic heart disease
History of congestive heart failure
History of cerebrovascular disease
History of hypertension
History of diabetes
Smoking status
Baseline blood tests
Were non-steroidal anti-inflammatory
drugs administered post-operatively
Was the patient taking ACE
inhibitor/ARB
Was an aminoglycoside administered
Was the patient taking diuretics
Was IV contrast administered
Urgency of operation
Operative approach

Years
Male, Female
Black/Other
I, II, III, IV, V
No, Yes
No, Yes
No, Yes
No, Yes
No, Type 1, Type 2
Current, Previous, Never, Unknown
Albumin, Creatinine, Haemoglobin values
No, Yes ibuprofen low dose, Yes ibuprofen high
dose, Yes other NSAID low dose, Yes other NSAID
high dose.
No, Yes

19

Primary operation performed

No, Yes
No, Yes
No, Yes - with/without renoprotective measures
Elective, Emergency
Open, Laparoscopic, Laparoscopic assisted,
Laparoscopic converted to open, Robotic
See Appendix D classified according to OPCS-4

20
21
22
23
24
25
26
27
28
29
30

Underlying pathology/ indication

Intra-operative contamination
Red cells transfusion: pre-op; peri-op
Post-operative renal replacement
Surgical site infection
Anastomotic leak
Referral to a medical specialty
30-day Clavien-Dindo grade
Post-operative length of stay
Creatinine values
Haemoglobin values

See Appendix E classified according to ICD-10

Clean, Clean-Contaminated, Contaminated, Dirty
No, Yes
No, Yes early, Yes late, Yes early and late
No, Yes
No, Yes, Not applicable no anastomosis
No, Yes (nephrology), Yes (general medicine)
None, I, II, IIIa, IIIIb, IVa, IVb, V
Enter days
Days 1, 2, 3, 4, 5, 6, 7 post-op; discharge day
Day 3 post-op

*
*
*
*

N.B. Q12-16 have sub-divisions for pre-operative and post-operative administration

A printable, user-friendly one-page summary of required data fields may be downloaded

from the OAKS project online hub: http://www.starsurg.org/project

18
collaborate@starsurg.org
www.STARSurg.org

Appendix B: Data dictionary

The best place to find the necessary information for each data field is indicated in italics below.
Day of surgery is defines as post-operative day 0.
Data field

Data options/
required data

Data dictionary

1
2
3
4

Patient age
Patient gender
Patient ethnicity
ASA score

Years
Male or Female
Black, Other
Enter grade I V

History of ischaemic heart disease

History of congestive heart failure

History of cerebrovascular disease

History of hypertension

History of diabetes

(Clinical notes) Age in whole years.

(Clinical notes)
(Clinical notes) Required for calculation of eGFR.
(Anaesthetic chart)
See
the
American
Society of
Anaesthesiologists
website
for
definitions:
http://www.asahq.org/Home/For-Members/Clinical-Information/ASA-Physical-StatusClassification-System.
Required to calculate RCRI.
Any documented diagnosis is acceptable, e.g. admission clerking or clinic letters.
Required to calculate RCRI.
Any documented diagnosis is acceptable, e.g. admission clerking or clinic letters.
Required to calculate RCRI.
Any documented diagnosis is acceptable, e.g. admission clerking or clinic letters.
Cerebrovascular disease includes either stroke or transient ischemic attack (TIA).
Required to calculate RCRI.
Any documented diagnosis is acceptable, e.g. admission clerking or clinic letters.
(Admission clerking, clinical notes). Required to calculate RCRI.

10

Smoking status

TARSurgUK@gmail.com
www.STARSurg.org

No
Yes
No
Yes
No
Yes

No
Yes
No
Type 1
Type 2
Current
Previous
Never
Unknown

(Admission clerking, clinical notes).

Current smokers include those who stopped smoking within the last 6 weeks.

19

11

For elective patients either 11(a) or 11(b) should be completed. For emergency patients both 11(a) and 11(b) should be completed. In addition, for emergency
patients, 11(c) should be completed if more than one blood test was taken on this admission prior to surgery.
Do not perform extra blood tests not required by the clinical team looking after the patient.

11a

Pre-admission blood tests

Creatinine
Haemoglobin
Albumin

Enter values

(Pathology system, clinical notes)

Include blood tests taken within the 90 days prior to operation. If multiple blood tests have
been taken during this period, record the lowest value. If no pre-admission blood tests are
available, please record this as 0.

11b

Admission blood tests

Creatinine
Haemoglobin
Albumin

Enter values

(Pathology system, clinical notes).

Include the first blood test results from this admission. Only include blood tests taken before
surgery

11c

Last pre-op blood tests

Creatinine
Haemoglobin
On post-operative days 0-3,
were non-steroidal antiinflammatory drugs
administered

Enter values

(Pathology system, clinical notes).

Include the last blood test result from this admission taken before surgery.

12a

12b

13a
13b

On post-operative days 4-7,

were non-steroidal antiinflammatory drugs
administered

Was the patient taking ACEi or

ARBs pre-operatively
Did the patient take ACEi or ARBs
peri-operatively

TARSurgUK@gmail.com
www.STARSurg.org

No
Yes ibuprofen, low dose
Yes ibuprofen, high dose
Yes other NSAID, low dose
Yes other NSAID, high dose

Options as in Q12(a)

No
Yes
No
Yes

Low dose: stat or intermittent administration of any NSAID.

High dose: administration of recommended daily allowance for 24hr.
For Q12(a) and Q12(b), if more than one NSAID was administered during each
respective period, please report the NSAID for which the most doses were
administered.
(Drug chart)
Pre-operative use: administration of at least 1 dose in the 7 days preceding surgery,
excluding the 24 hours prior to operation.
Peri-operative use: administration of at least 1 dose in the 24 hours prior to operation.

20

13c

Was the patient taking ACE

inhibitors or ARBs post-operatively

No
Yes

14a

Was the patient taking diuretics

pre-operatively
Was the patient taking diuretics
post-operatively
Was an aminoglycoside
administered peri-operatively

No
Yes
No
Yes
No
Yes

16a

Was intravenous contrast

administered pre-operatively

16b

Was intravenous contrast

administered post-operatively

No
Yes, RPM
Yes, no RPM
No
Yes, RPM
Yes, no RPM

17

Urgency of operation

Elective
Emergency

18

Operative approach

19

Primary operation performed

20

Underlying pathology/
indication

14b
15

TARSurgUK@gmail.com
www.STARSurg.org

Open
Laparoscopic
Laparoscopic,
assisted
Laparoscopic
converted to open
Robotic
Select main
procedure type
Select main
pathology type

Post-operative use: administration of at least 1 dose in the first 7 post-op days.

ACEi: Angiotensin Converting Enzyme inhibitors; include Ramipril, Captopril, Enalapril,
Fosinopril, Lisinopril, Quinapril. ARBs: Angiotensin Receptor Blockers; include Losartan,
Candesartan, Eprosartan, Irbesartan, Valsartan.
(Drug chart)
Pre-operative use: administration of at least 1 dose in the 7 days preceding surgery.
Post-operative use: administration of at least 1 dose in the first 7 post-op days.
Diuretics include Amiloride, Bendroflumethiazide, Bumetanide, Furosemide, Spironolactone.
(Drug chart)
Peri-operative use: administration of at least 1 dose intra-operatively or in the first 7 post-op
days. Aminoglycosides include Gentamycin, Streptomycin, Neomycin.
(Clinical notes, imaging system)
Pre-operative use: administration of contrast in the 7 days preceding surgery.
Post-operative use: administration of contrast in the first 7 post-operative days.
In case of multiple scans, report the closest pre-op and post-op scans to time of surgery.
RPM = Renoprotective measures. RPM are defined as administration of intravenous NAcetylcysteine (NAC) or intravenous bicarbonate prior to or after receiving contrast;
administration of NAC or bicarbonate must be on the same day as contrast was given.
(operation note, clinical notes)
Elective surgery: any planned admission for surgery.
Emergency surgery: any surgery on the same admission as diagnosis.
(operation note)
Laparoscopic: Surgery performed exclusively using instruments inserted in to the abdomen
through small ports.
Laparoscopic, assisted: Laparoscopic surgery in which an incision is enlarged to deliver a
specimen or to insert a gloved hand into the abdomen.
Laparoscopic converted to open: Surgery planned to be performed laparoscopically but for
unforeseen reasons decision made to change to an open approach.
(operation note, clinical notes)
(operation note, clinical notes)

21

21

Intra-operative contamination

Were red cells transfused preoperatively

Were red cells transfused perioperatively
Post-operative renal
replacement therapy

24

Surgical site infection (SSI)

25

Anastomotic leak

26

Referral to medical specialty

(enter day referral first made)

22a
22b
23

27

30-day Clavien-Dindo grade

TARSurgUK@gmail.com
www.STARSurg.org

Clean
CleanContaminated
Contaminated
Dirty
No
Yes
No
Yes
No
Yes early
Yes late
Yes early and
late
No
Yes

No
Yes
No anastomosis
No
Yes nephrology
Yes - general
medicine
None
Enter grade I-V

(operation note)
Clean: Gastrointestinal and genitourinary tracts not entered.
Clean-Contaminated: GI or genitourinary tracts entered but no gross contamination.
Contaminated: Gastrointestinal or genitourinary tracts entered with gross spillage or major
break in sterile technique.
Dirty: There is already contamination prior to operation (e.g. with faeces or bile).
(Drug chart, clinical notes, discharge letter)
Pre-operative transfusion: transfusion of at least 1 unit in the 7 days preceding surgery.
Peri-operative transfusion: transfusion of at least 1 unit on day of surgery, following induction
of anaesthesia, or during the first 2 days following surgery (days 0-2).
(Clinical notes, discharge letter)
Include renal replacement therapy of any duration performed during early and/or late
periods. Early is defined as post-op days 0-7, late is defined as post-op days 8-30.
Renal replacement therapy includes dialysis and haemofiltration.
(Clinical notes, discharge letter, clinic letters)
Use the Centre for Disease Controls SSI definition, which is any one of:
Purulent drainage from the incision
At least two of: pain or tenderness; localised swelling; redness; heat; fever; AND
The incision is opened deliberately to manage infection or the clinician diagnoses a
surgical site infection
Wound organisms AND pus cells from aspirate/ swab
(Clinical notes, discharge letter, clinic letters)
Include all anastomotic leaks. Include leaks detected by CT scan and/or intra-operatively;
and leaks managed conservatively or surgically.
(Clinical notes, discharge letter, clinic letters)
For all patients, include all post-operative referrals made to medical or nephrology services
for a renal indication. Include telephone discussions with renal/medical doctors. Do not
include referrals regarding non-renal problems, e.g. cardiology or respiratory conditions.
Record on which post-operative day the referral was first made.
(Clinical notes, discharge letter, clinic letters)
Please use the full 7-point (grade I, II, IIIa, IIIb, IVa, IVb, V) Clavien-Dindo scale.

22

28

Post-operative length of stay

Enter days

29

Creatinine values:
Days 1, 2, 3, 4, 5, 6, 7 post-op;
discharge day.

Enter values for:

Day 1 post-op
Day 2 post-op
Day 3 post-op
Day 4 post-op
Day 5 post-op
Day 6 post-op
Day 7 post-op
Discharge day

30

Haemoglobin:
Day 3 post-op

TARSurgUK@gmail.com
www.STARSurg.org

Enter value

(Clinical notes, discharge letter, clinic letters, electronic records)

This should be calculated from the first post-operative day to day of discharge.
If the patient remains admitted in hospital at the end of 30-day follow-up, enter 30
(Pathology system, clinical notes)
Leave blank if a blood test was not performed on that day (this will not affect your data
completion rate). Do not perform extra blood tests not required by the clinical team looking
after the patient.
If multiple blood tests were performed on the same day, please supply the value from the
test taken closest to 12pm.
For discharge day please supply the last blood test result taken on this admission. If patient
remained admitted at end of 30-day follow up, please supply the result of the last blood test
prior to end of 30-day follow up.
(Pathology system, clinical notes)
Enter the earliest haemoglobin available from day 3 post-op onwards.

23

Appendix C: Centre questionnaire

This centre questionnaire should be completed by the consultant supervising the
audit.
Question

Options

1) Are patients undergoing elective major

surgery at your centre reviewed at a formal
pre-operative assessment clinic?

Yes all patients;

Yes high risk patients only;
No

2a) Do your centres U&E (urea and

electrolytes) results include AKI stage?

Yes;
No

2b) Does your centre have an electronic

alerting system to flag patients that have
developed AKI?

Yes;
No

3) Does your centre employ a full-time

onsite nephrologist (consultant or associate
specialist grade at this hospital)?

Yes;
No

4) Does your centre offer inpatient dialysis?

Dialysis in ICU only (CRRT);

Acute dialysis in a renal centre;
Both

5) Is intra-operative goal directed fluid

therapy available at your centre for major
surgery?

Yes routinely employed (>50% of cases);

Yes not routinely employed (<50% of cases);
No

6) Are patients undergoing major surgery at

your centre admitted to high dependency/
intensive care units post-operatively?

Yes routinely (>50% of patients);

Yes most high risk patients only;
Never

ICU intensive care unit

CRRT Continuous Renal Replacement Therapy

TARSurgUK@gmail.com
www.STARSurg.org

24

Appendix D: OPCS-4.7 Procedure Codes

With reference to the operation note please select the closest code possible from
the list below to describe the procedure performed. If your hospitals coding
department has already designated an OPCS-4.7 code for the procedure, please
check this against the operation note for accuracy.
If a patient had a colectomy with a primary anastomosis and a covering stoma,
please code this as a colectomy with anastomosis.
OPCS Procedure Description
Code

Notes if OPCS-4.7 code available

G01

Oesophagogastrectomy

Include all G01 codes here

G02

Total oesophagectomy

Include all G02 codes here

G03

Partial oesophagectomy

Include all G03 codes here

G27

Total gastrectomy

Include all G27 codes here

G28

Partial gastrectomy

Include all G28 codes here

G49.1

Gastroduodenectomy

G49.2

Total excision of duodenum

G49.3

Partial excision of duodenum

G58.1

Total jejunectomy

Include all total jejunectomoies here (i.e.

codes G58.1, G58.2, G58.3)

G58.4

Partial jejunectomy

Include all partial jejunectomoies here (i.e.

codes G58.4, G58.5)

G69

Ileectomy (resection of ileum)

Include all G69 codes here

G75.3

Closure of ileostomy

H04

Total excision of colon and rectum

H04.1

Panproctocolectomy and ileostomy

H04.2

Panproctocolectomy and anastomosis of

ileum to anus creation of pouch

H05.1

Total colectomy and anastomosis

H05.2

Total colectomy and ileostomy

Include codes H05.2, H05.3

H06.1

Right hemicolectomy and anastomosis

Include all types of anastomosis here (i.e.

codes H06.1, H06.2, H06.3, H06.5, H07.1,
H07.2, H07.3, H07.5)

H06.4

Right hemicolectomy and ileostomy

Include codes H06.4, H07.4

H08.1

Transverse colectomy and anastomosis

Include all types of anastomosis here (i.e.

codes H08.1, H08.2, H08.3, H08.6)

H08.4

Transverse colectomy and stoma

Include codes H08.4, H08.5

H06.1

Left hemicolectomy and anastomosis

Include all types of anastomosis here (i.e.

codes H09.1, H09.2, H09.3, H09.6)

H06.4

Left hemicolectomy and stoma

Include codes H09.4, H09.5

TARSurgUK@gmail.com
www.STARSurg.org

Include codes H04.2 & H04.3

25

H10.1

Sigmoid colectomy and anastomosis

Include all types of anastomosis here (i.e.

codes H10.1, H10.2, H10.3, H10.6)

H10.4

Sigmoid colectomy and stoma

Include codes H10.4, H10.5

H15.4

Closure of colostomy

Include reversal of Hartmanns here

H29.1

Subtotal excision of colon and rectum

Include codes H29.1, H29.2

H29.3

Subtotal excision of colon

Include codes H29.3, H29.4

H33.1

Abdominoperineal excision

H33.2

Proctectomy

H33.3

Anterior resection

H33.6

Anterior resection and stoma

H33.5

Rectosigmoidectomy and stoma

J02.1

Hemihepatectomy

J02.3

Resection of segment of liver

J02.4

Wedge excision of liver

99

Other unlisted procedure (enter free text)

TARSurgUK@gmail.com
www.STARSurg.org

Include codes H33.3, H33.4

Include all hemihepatectomies here (i.e.

codes J02.1, J02.2, J02.6, J02.7)

26

Appendix E: ICD-10 Diagnosis Codes

99
K75
K66.0
K56.5
K26.3
K27.4
K55
K29.0.1
K50
A09
K55.7
K51
Y83
K57.3
K57.4
K26.0
K26.2
K63.2.3
K63.2.2
K63.2.1
K63.2.4
T18
K27.0
K27.2
K21
A49
K56.1
K62.5
E66
K22.3
K91.3
K63.1
S38
S31
D13
C26.2
C26.1
K56.2.1
K56.2.2

Other unlisted diagnosis (please enter free text)

Abscess of Liver
Adhesions: no bowel obstruction
Adhesions: with bowel obstruction
Anorectal Prolapse
Bleeding: peptic ulcer
Bleeding: small bowel / colon (no malignancy / diverticular
disease)
Bleeding: upper GI variceal haemorrhage
Colitis: Crohns disease
Colitis: infectious (e.g. C. Difficile)
Colitis: Ischaemic
Colitis: Ulcerative colitis
Complication of previous surgical operation / procedure
Diverticular disease: non-perforated
Diverticular Disease: with perforation
Duodenal Ulcer: non-perforated
Duodenal Ulcer: perforated
Fistula: Colovaginal
Fistula: Colovesical
Fistula: Enterocutaneous
Fistula: Gastrocolic
Foreign Body
Gastric Ulcer: non-perforated
Gastric Ulcer: perforated
Gastro-oesophageal reflux disease
Infection: other
Intestinal intussusception
Lower GI Haemorrhage: Unspecified
Obesity
Perforation of oesophagus
Postoperative Ileus
Stercoral perforation of colon
Trauma: non-penetrating (blunt)
Trauma: penetrating
Tumour: any benign tumour or polyp
Tumour: metastatic cancer (operation on a metastasis)
Tumour: primary cancer (operation on any primary tumour)
Volvulus: caecal
Volvulus: sigmoid

TARSurgUK@gmail.com
www.STARSurg.org

27

Appendix F: Clavien-Dindo classification system

Adverse post-operative events may be divided up into treatment failures, sequelae
and complications. Failure of treatment occurs when the original surgery fails to
achieve its intended benefits; for example, persistent pain following laparoscopic
cholecystectomy or tumour recurrence following cancer surgery. Sequelae are the
recognised consequences of a given procedure; for example, gut malabsorption
following a large small bowel resection or immune deficiency following splenectomy.
Any deviation from the normal post-operative course that has an adverse effect on
the patient and is not either a treatment failure or sequel, is a complication.
In the Clavien-Dindo classification10, the factor determining the severity of a
complication is the treatment required. Consequently, a given complication may be
graded differently depending on how it has been managed. For example, an
anastomotic leak may be managed just with antibiotics if it is contained (grade II) or
it may require re-operation under anaesthetic (grade IIIb).
Some other considerations:
Intra-operative complications are not considered unless they have an adverse
effect on the patient post-operatively. The only exception to this is intraoperative death; this is classified as grade V.

All post-operative adverse events are included, even when there is no

direct relationship to the surgery.

All adverse events within the follow-up period (30 days) are included,
even if they occur following discharge.

Diagnostic procedures are not included. For example, a diagnostic

oesophagoduodenoscopy (OGD) to look for a source of bleeding without any
intervention would not be considered a complication, but a therapeutic OGD
with clipping of a bleeding vessel would be considered a grade IIIa
complication. Since negative exploratory laparotomies are considered to
be diagnostic procedures, they should not be recorded as complications.

TARSurgUK@gmail.com
www.STARSurg.org

28

Grade

Definition (examples listed in italics)

Any deviation from the normal postoperative course without the need for
pharmacological (other than the allowed therapeutic regimens), surgical,
endoscopic or radiological intervention.
Allowed therapeutic regimens are: selected drugs (antiemetics, antipyretics,
analgesics, diuretics and electrolyte replacement), physiotherapy and wound
infections opened at the bedside but not treated with antibiotics.
Examples: Ileus (deviation from the norm); hypokalaemia treated with K;
nausea treated with cyclizine; acute kidney injury treated with intravenous
fluids.

II

Requiring pharmacological treatment with drugs beyond those allowed for

grade I complications. Blood transfusions and total parenteral nutrition are also
included.
Examples: Surgical site infection treated with antibiotics; myocardial infarction
treated medically; deep venous thrombosis treated with enoxaparin;
pneumonia or urinary tract infection treated with antibiotics; blood transfusion
for anaemia.

IIIa

Requiring surgical, endoscopic or radiological intervention, not under general

anaesthetic.
Examples: Therapeutic endoscopic therapy (do not include diagnostic
procedures); interventional radiology procedures.

IIIb

Requiring surgical, endoscopic or radiological intervention, under general

anaesthetic.
Examples: Return to theatre for any reason.

IVa

Life-threatening complications requiring critical care management single

organ dysfunction, or neurological complications including brain haemorrhage
and ischemic stroke (excluding TIA).
Examples: Single organ dysfunction requiring critical care management, e.g.
pneumonia with ventilator support, renal failure with filtration; SAH; stroke.

IVb

Life-threatening complications requiring critical care management multiorgan dysfunction.

Death of a patient

TARSurgUK@gmail.com
www.STARSurg.org

29

Appendix G: Key steps for successful inclusion of your centre

For local leads

contact details see
the STARSurg site.

For details on
project delivery and
the roles of different
team members, see
protocol section 13.

1. Contact your local lead about participation in the OAKS study at the
centre of your choice. They will connect you to any other interested
medical students and foundation doctors.
2. Form a mini-team of up to three collaborators. A medical student
should be co-ordinating the team and leading audit registration and data
collection. The student must be supported by at least one motivated
doctor. This can be any doctor from FY1 to consultant grade, but should
preferably be a junior doctor. The collaborating doctor could be:

A junior (e.g. FY1, FY2, CT1, CT2) you know on rotation in the surgical
department.
If you dont know any juniors working in the surgical teams, try walking
onto the ward to find an FY1 to ask who the best FY1/2 to help the audit
is; this approach often succeeds. If there is an FY1/2 on an academic
rotation, they may be well placed to help you.
The consultant who will be supervising your surgical placement.
The consultant lead for audit in the department of surgery.
A member of your local registrar-led research collaborative
(http://www.asit.org/resources/collaboratives).

3. Choose a 14 day consecutive data collection period to suit your

availability:

Period 1: 0800 Wednesday 23rd Sept to 0759 Wednesday 7th Oct.

Period 2: 0800 Wednesday 7th Oct to 0759 Wednesday 21st Oct.
Period 3: 0800 Wednesday 21st Oct to 0759 Wednesday 4th Nov.
Period 4: 0800 Wednesday 4th Nov to 0759 Wednesday 18th Nov.
Up to four teams of students can cover consecutive 2-week periods,
working together to deliver 30-day follow-up.

For more details on

REDCap and data
security visit the
project hub.

4. Ensure that you secure formal audit approval from your hospitals
clinical audit department prior to commencing data collection. This may
seem daunting at first but is in fact quite straight forward. Every hospital
has an audit department and it is a simple case of approaching them with
the information we have prepared in this protocol, and applying this to the
local audit registration form. You will need a consultant surgeon to
support you and sign the hospitals audit form.
Ensure that the audit department know that this is part of a national
project and that you will enter data on REDCap. Contact your hospitals
Caldicott Guardian (often the medical director the audit department
can help you find out who this is) to request permission to submit data to
REDCap.
It is essential that you begin this process immediately; approval can
take up to a month. You may have to contact or even visit the hospital
before your placement starts to ensure that you will be ready. If you
have any difficulties contact your local lead, your supervising junior
doctor/ consultant or the steering committee.

TARSurgUK@gmail.com
www.STARSurg.org

30

5. Agree with your audit office and Caldicott Guardian how you will facilitate
1-year follow-up (this will be done by different mini-teams in Autumn
2016). In order to make it possible to enter follow-up data at 1-year, it
must be possible to link REDCap records to hospital patient records.
There are three methods of doing this (see protocol section 10).
6. Once the audit is registered and you have Caldicott Guardian approval,
please forward evidence of this to your universitys local lead. REDCap
accounts will not be issued until proof of audit registration is received.
7. Arrange to meet with the other members of your mini-team, including the
junior doctor and, if possible, supervising consultant. If possible meet up
with the preceding mini-team at your centre also. They will have a lot of
helpful advice regarding what worked well. In you mini-team agree in
advance who will be responsible for each stage of the project, e.g.
identifying patients, collecting baseline data, completing follow-up, data
entry to REDCap. Talk through how you will identify patients and collect
required data, it will be particularly helpful if the consultant is present to
offer guidance regarding this. Agree who will access blood test results;
will students have a login or will the junior doctor check the results?
8. Complete a practice pilot audit day: Complete one day of audit at your
centre in the week prior to the main start day, and record the relevant
information on the dedicated online REDCap data system or
supplementary . This will allow you to become familiar with the best way
to identify patients, and data collection methodology. Contact us with any
queries from the day. This will allow the steering committee to iron-out
any problems.
9. Identify all patients fitting the inclusion criteria within your specified two
week window.
10. Regularly follow-up for information on complications over the 30-day
post-operative period. This study is prospective, so you should not
wait until the end of the post-operative period to follow-up patients (this
would be retrospective). Discuss the best way to follow up patients with
the consultant supervising your audit, as this will vary from centre to
centre.
For possible followup strategies see
protocol, Section 8.

Be proactive in identifying post-operative adverse events, as this

will prevent under-estimation of true complication rates. Remember
that in this audit no changes to normal patient follow-up should be
made.
11. Ensure all data has been uploaded to the REDCap system and you have
completed all fields, avoiding missing data points. If more than 5% of
patients at your centre are missing data, your centre cannot be included
and your name will be withdrawn from the author list.
12. It is a condition of participation in OAKS that following completion of the
audit at your centre you must ensure that your local results are
presented to your hospitals surgical department and/or reported back to
the audit department. You may also like to return to present again at a
later date, when the national results of the OAKS study become
available.

TARSurgUK@gmail.com
www.STARSurg.org

31

Appendix H: Ethics Waiver

TARSurgUK@gmail.com
www.STARSurg.org

32

Appendix I: References
1. Chapman SJ, Glasbey JC, Khatri C et al. Promoting research and audit at
medical school: evaluating the educational impact of participation in a
student-led national cohort study. BMC Med Educ. 2015 Mar 13;15(1):47.
2. Bhangu A, Kolias AG, Pinkney T et al. Surgical research collaboratives in the
UK. Lancet 2013;382(9898): 1091-1092.
3. STARSurg Collaborative. Impact of postoperative non-steroidal antiinflammatory drugs on adverse events after gastrointestinal surgery. The
British journal of surgery 2014.
4. Nepogodiev D, Chapman S, Glasbey J et al on behalf of the STARSurg
Research Collaborative. Determining Surgical Complications in the
Overweight (DISCOVER): A Multicentre Observational Cohort Study to
Evaluate the Role of Obesity as a Risk Factor for Post-operative
Complications in General Surgery. BMJ Open 2015;5(7):e008811.
5. Kim M, Brady JE, Li G. Variations in the risk of acute kidney injury across
intraabdominal surgery procedures. Anesth Analg. 2014 Nov;119(5):1121-32.
6. Teixeira C, Rosa R, Rodrigues N. Acute kidney injury after major abdominal
surgery: a retrospective cohort analysis. Crit Care Res Pract.
2014;2014:132175.
7. Masoomi H, Carmichael JC, Dolich M et al. Predictive factors of acute renal
failure in colon and rectal surgery. Am Surg. 2012 Oct;78(10):1019-23.
8. Lee TH, Marcantonio ER, Mangione CM et al. Derivation and prospective
validation of a simple index for prediction of cardiac risk of major noncardiac
surgery. Circulation 1999;100(10): 1043-1049.
9. Algorithm for detecting Acute Kidney Injury (AKI) based on serum
creatinine changes with time, NHS England http://www.england.nhs.uk/wpcontent/uploads/2014/06/psa-aki-alg.pdf
10. Clavien PA, Barkun J, de Oliveira ML et al. The Clavien-Dindo classification
of surgical complications: five-year experience. Annals of surgery
2009;250(2): 187-196.

TARSurgUK@gmail.com
www.STARSurg.org

33