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Trainee-led Surgical Research
        Collaboratives


 The West Midlands Research Collaborative
               experience
The WMRC

• Background - why we formed

• Aims

• Why it works
Project
                          Methodology
                           & design            Data
                                             Collection
    Team leading
                                             & analysis
     & working



                                              Write papers
                                                                           Patients
Enhance CV

                            Trainee

 Publications
                                                                                           Multicentre
& Presentations                          Benefits of                                         Trials
                                          Research
                   Transferable         Collaborative
                       skills                                           Quality of
                                                                        Research


                                                                                     More clinical
                             Region                          Better                  surgical trials
                                                          recruitment
Getting it off the Ground
• Enthusiastic Trainees

• Senior Support and guidance

• Consultant trainer support

• Trials Unit(s)

• National Support
Running the WMRC
• Regular meetings as a group

• Formation of a management committee

• Communication
      • www.wmresearch.co.uk
      • Forums
      • E-mail
How to set up a collaborative
Formation of a committee
   Network Development
   Trial Development
   Overall organisation
Committee members:
   Chairperson
   Secretary
   Webmaster
   A junior surgical liaison
   Treasurer
   New study manager
   Chief Investigator of each study
Committee



     Trial 1              Trial 2              Trial 3
Chief Investigator   Chief Investigator   Chief Investigator



    Working              Working              Working
     group                group                group



      Local                Local                Local
  investigators        investigators        investigators
How to set up a collaborative
Monthly group meeting
    Discuss existing trials
    New project presentations and discussions
    Educational talks
      Cancer Intelligence Unit
      Trials Unit
      Clinical
    Journal club


 Individual trials meetings
Current Research Portfolio
3 RCTs           Cohort studies
  ROSSINI         CANOES
                   CHARMS
  DREAMS
                   ABPI
  PHAROES

                  Multicentre Audit
                   Pancreatitis Study

                  Qualitative research
Current Progress
• Around 45 trainees have GCP accreditation and are
  randomising to ROSSINI
• Many more (junior) trainees are involved in our trials

• £232,000 NIHR RfPB grant for ROSSINI
• £131,000 BDRF grant for DREAMS
• £150,000 company sponsorship for PHAROES

• Presentations/Papers
• National Meetings
ROSSINI Trial
    Reduction Of Surgical Site Infection
       using a Novel Intervention




 A multicentre, prospective randomised controlled trial of a
wound-edge protection device to reduce surgical site infection
ROSSINI Trial

• Primary Hypothesis:

  Use of a wound-edge protection device in
  adults undergoing laparotomy will result in a
  reduced rate of surgical site infection (SSI) at
  30 days.
Inclusion/Exclusion Criteria
• Inclusion criteria
  – Any laparotomy
  – Any Incision (eg midline, transverse, Kocher’s etc)
  – Emergency or Elective
• Exclusion criteria
  – Unable to consent
  – Laparoscopic assisted cases
  – Previous laparotomy within last 3 months
ROSSINI – Process


PATIENT       CONSENT        OPERATION          FOLLOW UP A     FOLLOW UP B
LISTED
              Consent form   Randomised in      Day 5-7 wound   Day 30-33 wound
Patient       completed      theatre (50:50)    review          review
Information
Sheet given   CRF 1          CRF 2              CRF 3           CRF 4+5



                                      EUROQOL EQ-5D




                             RESOURCE USE

                             Completed at end

                             CRF 6
ROSSINI sites (West Mids)
• University Hospital           • University Hospital Coventry
  Birmingham                      and Warwickshire
• Russells Hall Hospital        • Royal Shrewsbury Hospital
• Walsall Manor Hospital        • Princess Royal Hospital Telford
• City and Sandwell Hospitals   • Hereford County Hospital
• Heartlands and Good Hope      • Worcester Royal Hospital
  Hospitals                     • George Elliot Hospital,
• Warwick Hospital                Nuneaton
• University Hospital North
  Staffordshire
• New Cross Hospital
  Wolverhampton
ROSSINI sites (National)
• Royal Derby Hospital     •   St Marks, London
• Wrightington,Wigan and   •   Stepping Hill, Stockport
  Leigh                    •   Bolton
• Derriford Hospital,      •   The Christie, Manchester
  Plymouth
                           •   Wrexham
• Hope Hospital, Salford
                           •   Glan Clwyd
• Royal Devon and Exeter
  Hospital                 •   Manchester Royal Infirmary
• Medway                   •   Yeovil
• Maidstone + Tunbridge
  Wells
• The Homerton, London
ROSSINI recruitment at 31st March 2011
                                               900                                                                                                     20

                                               800                                                                                                     18

                                                                                                                                                       16
                                               700
                          Patients recruited                                                                                                           14
                                               600




                                                                                                                                                            Sites open
                                                                                                                                                       12
                                               500
                                                                                                                                                       10
                                               400
                                                                                                                                                       8
                                               300
                                                                                                                                                       6

                                               200
                                                                                                                                                       4

                                               100                                                                                                     2

                                                 0                                                                                                     0




                                                     Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12
                                                         Apr-10 Jun-10 Aug-10 Oct-10 Dec-10 Feb-11 Apr-11 Jun-11 Aug-11 Oct-11 Dec-11 Feb-12
Predicted sites open                                   0   1   1   2   3   4   5   6   7   9   10 12 13 15 16 18 18 18 19 19 19 19 19 19 19
Actual sites open                                      1   1   1   2   3   5   9   12 12 13 15 17
Actual sites recruiting                                1   1   1   2   3   4   7   8   9   10 13 13
Minimum cumulative recruitment
                                                       0   3   6   11 19 30 44 60 78 102 129 161 195 235 277 324 371 418 468 517 567 616 665 715 764
           (750)
Actual cumulative recruitment                         12 17 21 26 44 51 69 82 109 117 157 201 261
Spreading the word
• RCS support
• SARS / ASGBI support

• Presentations at ASIT, ASGBI, SARS, ACPGBI

• Networking with other groups of trainees
• London / Trent / Southampton / Bristol / Leeds
Future Development

LSRG

SPARCS

Leeds group

National cardiothoracic research collaborative
Contact us

WMRC Website:
http://www.wmresearch.org.uk

E mail committee members:
committee@wmresearch.co.uk
Dexamethasone Reduces Emesis
After Major Gastrointestinal Surgery
TRIAL DESIGN AND PATHWAY
• Phase
  3, prospective, double-
  blind, multicentre, RCT.

• Consecutive
  unobstructed patients
  undergoing colorectal
  surgery (inside and
  outside of ERAS).

• Randomised 1:1
WHAT YOU NEED TO DO TO
           COLLABORATE

• Further information at: wmresearch.org.uk

• E-mail: dreams@wmresearch.co.uk

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The West Midlands Research Collaborative

  • 1. Trainee-led Surgical Research Collaboratives The West Midlands Research Collaborative experience
  • 2. The WMRC • Background - why we formed • Aims • Why it works
  • 3. Project Methodology & design Data Collection Team leading & analysis & working Write papers Patients Enhance CV Trainee Publications Multicentre & Presentations Benefits of Trials Research Transferable Collaborative skills Quality of Research More clinical Region Better surgical trials recruitment
  • 4. Getting it off the Ground • Enthusiastic Trainees • Senior Support and guidance • Consultant trainer support • Trials Unit(s) • National Support
  • 5. Running the WMRC • Regular meetings as a group • Formation of a management committee • Communication • www.wmresearch.co.uk • Forums • E-mail
  • 6. How to set up a collaborative Formation of a committee  Network Development  Trial Development  Overall organisation Committee members:  Chairperson  Secretary  Webmaster  A junior surgical liaison  Treasurer  New study manager  Chief Investigator of each study
  • 7. Committee Trial 1 Trial 2 Trial 3 Chief Investigator Chief Investigator Chief Investigator Working Working Working group group group Local Local Local investigators investigators investigators
  • 8. How to set up a collaborative Monthly group meeting  Discuss existing trials  New project presentations and discussions  Educational talks Cancer Intelligence Unit Trials Unit Clinical  Journal club  Individual trials meetings
  • 9. Current Research Portfolio 3 RCTs  Cohort studies ROSSINI  CANOES  CHARMS DREAMS  ABPI PHAROES  Multicentre Audit  Pancreatitis Study  Qualitative research
  • 10. Current Progress • Around 45 trainees have GCP accreditation and are randomising to ROSSINI • Many more (junior) trainees are involved in our trials • £232,000 NIHR RfPB grant for ROSSINI • £131,000 BDRF grant for DREAMS • £150,000 company sponsorship for PHAROES • Presentations/Papers • National Meetings
  • 11. ROSSINI Trial Reduction Of Surgical Site Infection using a Novel Intervention A multicentre, prospective randomised controlled trial of a wound-edge protection device to reduce surgical site infection
  • 12. ROSSINI Trial • Primary Hypothesis: Use of a wound-edge protection device in adults undergoing laparotomy will result in a reduced rate of surgical site infection (SSI) at 30 days.
  • 13. Inclusion/Exclusion Criteria • Inclusion criteria – Any laparotomy – Any Incision (eg midline, transverse, Kocher’s etc) – Emergency or Elective • Exclusion criteria – Unable to consent – Laparoscopic assisted cases – Previous laparotomy within last 3 months
  • 14. ROSSINI – Process PATIENT CONSENT OPERATION FOLLOW UP A FOLLOW UP B LISTED Consent form Randomised in Day 5-7 wound Day 30-33 wound Patient completed theatre (50:50) review review Information Sheet given CRF 1 CRF 2 CRF 3 CRF 4+5 EUROQOL EQ-5D RESOURCE USE Completed at end CRF 6
  • 15. ROSSINI sites (West Mids) • University Hospital • University Hospital Coventry Birmingham and Warwickshire • Russells Hall Hospital • Royal Shrewsbury Hospital • Walsall Manor Hospital • Princess Royal Hospital Telford • City and Sandwell Hospitals • Hereford County Hospital • Heartlands and Good Hope • Worcester Royal Hospital Hospitals • George Elliot Hospital, • Warwick Hospital Nuneaton • University Hospital North Staffordshire • New Cross Hospital Wolverhampton
  • 16. ROSSINI sites (National) • Royal Derby Hospital • St Marks, London • Wrightington,Wigan and • Stepping Hill, Stockport Leigh • Bolton • Derriford Hospital, • The Christie, Manchester Plymouth • Wrexham • Hope Hospital, Salford • Glan Clwyd • Royal Devon and Exeter Hospital • Manchester Royal Infirmary • Medway • Yeovil • Maidstone + Tunbridge Wells • The Homerton, London
  • 17. ROSSINI recruitment at 31st March 2011 900 20 800 18 16 700 Patients recruited 14 600 Sites open 12 500 10 400 8 300 6 200 4 100 2 0 0 Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12 Apr-10 Jun-10 Aug-10 Oct-10 Dec-10 Feb-11 Apr-11 Jun-11 Aug-11 Oct-11 Dec-11 Feb-12 Predicted sites open 0 1 1 2 3 4 5 6 7 9 10 12 13 15 16 18 18 18 19 19 19 19 19 19 19 Actual sites open 1 1 1 2 3 5 9 12 12 13 15 17 Actual sites recruiting 1 1 1 2 3 4 7 8 9 10 13 13 Minimum cumulative recruitment 0 3 6 11 19 30 44 60 78 102 129 161 195 235 277 324 371 418 468 517 567 616 665 715 764 (750) Actual cumulative recruitment 12 17 21 26 44 51 69 82 109 117 157 201 261
  • 18.
  • 19. Spreading the word • RCS support • SARS / ASGBI support • Presentations at ASIT, ASGBI, SARS, ACPGBI • Networking with other groups of trainees • London / Trent / Southampton / Bristol / Leeds
  • 20. Future Development LSRG SPARCS Leeds group National cardiothoracic research collaborative
  • 21. Contact us WMRC Website: http://www.wmresearch.org.uk E mail committee members: committee@wmresearch.co.uk
  • 22. Dexamethasone Reduces Emesis After Major Gastrointestinal Surgery
  • 23. TRIAL DESIGN AND PATHWAY • Phase 3, prospective, double- blind, multicentre, RCT. • Consecutive unobstructed patients undergoing colorectal surgery (inside and outside of ERAS). • Randomised 1:1
  • 24. WHAT YOU NEED TO DO TO COLLABORATE • Further information at: wmresearch.org.uk • E-mail: dreams@wmresearch.co.uk

Editor's Notes

  1. FIRST PROSPECTIVE, RCT!