SHAPE Study Protocol
Survey of Hernia Antibiotic Prophylaxis usE
May 2012
Version 1.5
www.lsrg.co.uk/shape
New Project Proposal Guidance
Contents
Protocol
Background
Aim
Outcomes
Inclusion and Exclusion
Timeline
Stage 1: Investigator Recruitment, Registration and Training
Stage 2: Surveying and Validation
Analysis, write-up and submission
Questionnaires
References
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Chief Investigator
Dr Alex Aiken,
Clinical Research Fellow
London School of Hygiene and Tropical Medicine
Work 0207 7927 2921
Mobile 07913 068161
Steering Committee
Alex Aiken alexander.aiken@lshtm.ac.uk
James Haddow james.haddow@mac.com
Nicholas Symons n.symons@imperial.ac.uk
For enquiries please contact a member of the steering committee.
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Protocol
Background
A recent Cochrane Review1 of evidence from randomised controlled trials
concluded that it is unclear whether or not antibiotic prophylaxis is beneficial in
elective inguinal hernia repairs in adults: there is weak evidence of a benefit,
but not enough for the reviewers to be certain of effectiveness. Guidelines
issued by the National Institute for Clinical Excellence (NICE) in the UK do not
give a fixed recommendation for elective hernia repairs2. Therefore, there is
scope for variation in clinical practice, without any implication of a there being a
"correct" approach. Differential use of antibiotic prophylaxis in hernia surgery
therefore has implications for risk of Surgical Site Infection (SSI), costs
associated with the procedure and antibiotic resistance pressure. Large surveys
of the use of antibiotic prophylaxis in elective hernia repairs in adults have
previously been conducted in Italy, Spain and Brazil but never in the UK.
Aim
The SHAPE study (Survey of Hernia Antibiotic Prophylaxis usE) aims to
describe the extent of variation in use of antibiotic prophylaxis in inguinal
hernia repair surgery in adults across England and Wales.
Outcomes
The primary outcome measure is percentage of surgeons routinely using
antibiotic prophylaxis in NHS hospitals. Secondary measures include the types
and durations of antibiotic prophylaxis routinely used and perceptions about its
effectiveness.
Inclusion and Exclusion
Site investigators
recruited
•Initially London
and SE
•NHS only
•Inguinal hernia
repairs
•Adults
Surgeons identified
by investigators
•All consultants
and associate
specialists
•General surgery
Surveys performed
•Surgeons who've
not performed
inguinal hernia
repair in last 12
months excluded
All surgeons performing elective inguinal hernia repairs independently on
adults in NHS Hospitals in England and Wales will be eligible, though in the first
phase of the project we will restrict to hospitals in London and the South-East.
Although surgeons performing hernia surgery exclusively in private hospitals
will not be included, we anticipate that there will relatively few surgeons in this
category. At each hospital site all consultants and associate specialist surgeons
in general surgery will be included. We will exclude surgeons who have not
performed elective inguinal hernia repairs on adults in the last 12 months.
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Specialist registrars or equivalent will not be included as they may not be able
to exercise independent choices about antibiotic prophylaxis use. Other types of
hernia repair and paediatric surgery will not be eligible for inclusion.
Timeline
We will use a two-stage survey process. Stage 1: recruit, train and set targets for
local investigators in each participating hospital. Stage 2: Each local
investigators will interview identified surgeons within their hospital.
Development
27/02/2012 Project proposal
28/03/2012 Questionnaire testing starts
24/04/2012 Questionnaire testing finishes
Stage 1
06/05/2012 Investigator recruitment starts
25/05/2012 Deadline for investigator registration
28/05/2012 Investigator briefing (7pm, Seminar Room, Level 2, Podium, UCLH)
Stage 2
01/06/2012 Surveying opens
30/06/2012 Surveying closes
31/07/2012 Survey validation deadline
Write-up
31/08/2012 Statistical analysis completed
30/09/2012 Manuscript draft sent out for review by Investigators
14/10/2012 First submission of manuscript
Stage 1: Investigator Recruitment, Registration and
Training
Investigator Recruitment
Recruitment will be supported by a microsite on LSRG website. We will initially
aim to run the study within London and the SE of England, in the area covered
by LSRG members. Depending on funding, we may subsequently extend the
study to other regions of England and Wales through the following collaborative
networks:
 West Midlands Research Collaborative: committee@wmresearch.co.uk
 Welsh Barber Surgeons Research Group: julie.cornish@gmail.com
 East of England Surgical Research Group: sipilgrim@hotmail.com
 Mersey Research Group for General Surgery: mergs@liverpool.ac.uk
 South Peninsula Audit and Research Collaborative for Surgeons:
sparcsexec@gmail.com
 Yorkshire Surgical Research Collaborative: danberal@hotmail.com
 Trent Surgical Research Collaborative: David.Humes@nottingham.ac.uk
Further calls will go out via Twitter, LinkedIn, Facebook and Synapse. A
maximum of one investigator per hospital will be recruited – in the event of
multiple applicants per hospital, the first applicant to complete the registration
process outlined below be will offered the position.
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Registration of Investigators and Site Details
Potential investigators will register the following data via SurveyMonkey (see
Questionnaires section).
 Their name and contact details
 Site name to be surveyed
 Site category (DGH, Teaching Hospital)
 Submit list of names of those to be surveyed (list all names of consultants
and associate specialists in general surgery)
 Total number of consultants and associate specialists to be approached
 The Trust guidelines for antibiotic prophylaxis for elective inguinal
hernia repairs.
Training of Investigators
All registered investigators will be sent written materials about the study and
will go through a briefing/training session. This will ensure all investigators
understand the purpose of the study, that the survey is administered
consistently and that the maximum response rate is achieved.
Any investigator failing to complete the interview stage will unfortunately be
unable to proceed to Stage 2.
Stage 2: Surveying and Validation
Administration of survey
Investigators will approach the individual surgeons identified in stage one and
administer the survey face-to-face. There will be three media options to record
the survey answers:
1. Paper pro formas (to be transcribed onto SurveyMonkey by investigator)
2. Direct recording into SurveyMonkey using a mobile device
3. Direct recording into SurveyMonkey on desktop computer
Each investigator will have a unique collector URL to track collection. Weekly
collection newsletter will be published to show where each investigator is.
Those who are struggling with response rate will be individually supported by
the steering committee.
We aim for each investigator to exceed a response rate of 90% with an overall
response rate of >95% and for the surveys to be completed in the calendar
month of June 2012.
Questionnaire
The questionnaire includes a question to determine the beliefs of surgeons
towards the benefits of prophylaxis over placebo, following an equipoise
methodology used previously in the UK3 (see Questionnaires section).
Survey Reliability Sub-study
A random sample of 5% of those surveyed will be independently re-surveyed to
determine the reliability of the two-stage methodology used here – this is
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known as a test-retest approach4. Investigators will be aware that there will be
an independent re-survey of a random sub-set of their surveys.
Analysis, write-up and submission
The data will be analysed using simple descriptive statistics. A correlation coefficient (r) will be used to determine the consistency in the test-retest
reliability sub-study. All Investigators will be invited to review and comment on
the preliminary draft manuscript before submission. Our primary target
audience is surgeons working in the UK, so we will target journals including the
British Journal of Surgery and Hernia.
Authorship
We will aim to publish using the desired authorship model of the LSRG, which is
where the paper is authored under “London Surgical Research Group” and then
all investigators are listed in the PubMed citable author section in order of
contribution. For more information on this authorship model please see
http://www.lsrg.co.uk/about-us/how-it-works.
Please note: acceptance of this authorship model is at the journal’s discretion.
It is difficult to obtain a guarantee before the paper is written as the success of
the survey and its results will have a large influence. Unfortunately, it is possible
that the steering committee may be requested to limit the number of authors on
the paper. If this is the case then those who have contributed to the
development, delivery, analysis and writing of the paper will be included in the
author section. All other investigators will be listed in the acknowledgements
section. Whilst this may not be as desireable, it will still be a very significant
publication to be listed on your CV, and will count for much more than small
audits and case reports for example. You will also still be contributing to a paper
developed and delivered by a trainee research collaborative, which will be a
unique thing itself.
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Questionnaires
The registration survey for stage 1 can be previewed here (please note this is
not the live link – data can be entered but will not be recorded):
http://svy.mk/IlcL1A
The questionnaire used in stage 2 can be previewed here (please note this is not
the live link – data can be entered but will not be recorded):
http://svy.mk/IldfVg
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References
1. Sanchez‐Manuel FJ, Lozano‐García J, Seco‐Gil JL, et al. Antibiotic prophylaxis
for hernia repair. In: The Cochrane Library. John Wiley & Sons, Ltd. Available at:
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003769.pub4/abstr
act;jsessionid=1B319EFFFFFFF5A603B915CBB73BD85D.d03t03. Accessed
March 24, 2012.
2. NICE. Search Guidelines ‘Hernia’. NICE. Available at:
http://www.nice.org.uk/Search.do?x=0&y=0&searchText=hernia+&newsearch
=true#/search/?reload. Accessed March 24, 2012.
3. Latthe PM, Braunholtz DA, Hills RK, Khan KS, Lilford R. Measurement of
beliefs about effectiveness of laparoscopic uterosacral nerve ablation. BJOG: An
International Journal of Obstetrics & Gynaecology. 2005;112(2):243–246.
4. Fowler FJ. Survey Research Methods. Sage Publications; 2009.
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