Less and better surgical research needed: using pilot & - - PowerPoint PPT Presentation

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Less and better surgical research needed: using pilot & - - PowerPoint PPT Presentation

Jan 31, 2023 317 likes •912 views

Less and better surgical research needed: using pilot & feasibility work to optimise trial design Jane M Blazeby Professor of Surgery, University of Bristol Honorary Consultant Surgeon, University Hospitals Bristol NHS Foundation Trust

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Less and better surgical research needed: using pilot & feasibility work to optimise trial design

Jane M Blazeby Professor of Surgery, University of Bristol Honorary Consultant Surgeon, University Hospitals Bristol NHS Foundation Trust

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What is a successful RCT in surgery?

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Methodological & cultural challenges

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How to use pilot & feasibility work to

  • ptimise a main (successful) RCT?
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Definitions of pilot & feasibility studies

1. Feasibility study 2. Pilot study

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Pieces of research done before a main study in order to answer the question “Can this study be done?”

Feasibility study

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Pilot study (usually randomised)

A version of the main study that is run in miniature to test whether the components

  • f the main study can all work together
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For example…

  • No. of patients screened, eligible & randomised

Application of inclusion & exclusion criteria Outcome measures (& blinding) Data collection (e.g. systems, forms, attrition) Intervention & co-interventions The team….

Components assessed in P & F work

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Purpose of pilot & feasibility studies

  • To establish if the main trial is possible
  • To optimise the design of the main trial
  • To work out key issues around feasibility

No!

  • To study the difference between

treatments to get an idea if the new intervention works.

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“A comparison of procedures such as gastric bypass with adjustable gastric banding, would be desirable.... .....however, this may not be possible because

  • f expert opinion”
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Uncertainties

  • Recruitment
  • Adherence to allocated treatment &

cross over

Avery KNL et al. (2015) Optimising the design of internal pilot work to inform efficient randomised controlled trials: issues to consider when developing progression criteria. Trials 16 (suppl. 2): P10.

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Designed with an internal pilot phase

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The By-Band Study

Eligible for By-Band (60%) Band N=362 Bypass N=362

Establish feasibility in two centres with an internal pilot and QuinteT Recruitment Intervention

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  • Funder & trial team agree

in advance

  • Reviewed at set time point
  • Stop main trial if not viable

Progression criteria

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  • Recruit
  • Screen 400 pts in 2 years
  • 60% of all patient eligible
  • Randomise 30% & then 50%

(i.e.79 patients)

  • < 5% crossover

Criteria set

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Surgeons recruiting into By-Band

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Recruitment at end of internal pilot

Oct 12 Jan 14

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Recruitment investigation

Recruitment after 8 months

Oct 12

Recruitment feedback

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  • Recruit
  • Screened 330 (target 400)

pts in 2 years

  • 65% (target 60%) eligible
  • Randomised 80 (target 79)
  • 3.5% (target 5%) crossover

How did we do?

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Pilot (2012) to main RCT (2014)

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Expanded into 11 UK centres

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Current recruitment (11 centres)

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Musgrove Park Hospital, Taunton Richard Welbourn Nicki Salter James Byrne Amy Long University Hospital, Southampton Nick Davies Claire Woods Bournemouth & Christchurch Hospital Jeremy Hayden Catherine Moriarty St James Hospital, Leeds Neil Jennings Paul Corrigan City Hospitals, Sunderland Ian Finlay Jackie Dingle Royal Cornwall Hospital, Truro Rishi Singhal Sally Abbott Birmingham Heartlands Hospital Paul Leeder Alison Paton Royal Derby Hospital Nick Carter Tracey Lee Queen Alexandra Portsmouth Sanjay Agrawal Marites Montemayor Homerton University Hospital Ahmed R. Ahmed Jasmine Jose St Marys Hospital, Imperial

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Purpose of pilot & feasibility studies

  • To establish if the main trial is possible
  • To optimise the design of the main trial
  • To work out key issues around feasibility
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Feasibility study: Phase A & B

Feasibility Study (funded)

Phase A

Which interventions? What outcome measures? And other things….

Phase B

Pilot RCT

Phase C

Main RCT

Not (yet) funded

Simple Complex ‘Nothing’

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Understand current practice Explore views of stakeholders

Case studies

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What is a ‘dressing’?

School of

SOCIAL AND COMMUNITY MEDICINE

  • Inconsistencies in what is considered as a ‘dressing’
  • Is glue a dressing?
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Relevance of ‘simple & complex’

Surgeon 1016

I’ve never heard of the terms [simple and complex] in terms of dressings. The vast majority ……have got a simple covering over the wound.

Nurse 1002

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Survey details

  • Prospective, in theatre
  • 14 days
  • Emergency/elective
  • Upper/lower GI

21 centres 727 patients 1794 wounds

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Patients n = 727 (%)

Sex Female 375 (52) Age <30 30-50 51-70 71+ 118 (16) 193 (26) 253 (35) 158 (22) Diabetes 62 (9) BMI <20 20-25 26-30 30+ 50 (7) 275 (39) 238 (34) 141 (20) UGI Oesophagogastric Pancreaticobiliary Anti-reflux surgery Bariatric surgery Cholecystectomy 8 (1) 11 (2) 10 (1) 11 (2) 153 (21) LGI Colectomy Hartmanns procedure Rectal resection Stoma 82 (11) 10 (1) 40 (6) 48 (6) General Hernia repair Appendicectomy Laparoscopy Small bowel Other 128 (17) 109 (15) 20 (3) 17 (2) 76 (10)

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n = 1794 (%)

Simple

1203 (68)

Advanced/complex

18 (1)

Tissue adhesive

485 (27)

None

63 (4)

Survey of dressings: types used

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New design of pilot RCT (Phase B)

Any type of simple dressing e.g. Opsite etc. Any type of tissue adhesive “As-a-dressing”

Randomise

‘No’ dressing

Inclusion Criteria Aged 16 or over Elective or unplanned abdo. surgery or C. section Willing to participate and follow-up for 4-8 weeks Exclusion Criteria Abdominal or other major surgery in the last 3/12 Allergy to dressings Intention to close the wound with tissue adhesive Surgery with no skin incision Lack of ability to read/understand English

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Feasibility study: Phase A & B

Feasibility Study (funded)

Phase A

Which interventions? What outcome measures? And other things….

Phase B

Pilot RCT

Phase C

Main RCT

Not (yet) funded

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SSI: Outcome measures

Additional treatment Serous discharge Erythema Purulent exudate Separation of deep tissue Isolation of bacteria Stay as inpatient >14 days

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Bluebelle SSI measure

  • Developed from the literature
  • Interviews with patients and staff
  • Pre-testing and validation
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Validation study design

Recruitment Follow up clinical assessments

  • 1. By telephone: Bluebelle observer SSI assessment
  • 2. Face to face: reference SSI assessment (CDC criteria)

Patient self assessment postal questionnaires

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  • 1. Patient reported SSI assessment
  • 2. Observer SSI assessment
  • 3. Reference SSI assessment

Planned analysis Recruited 415 pts (Bristol & Bham)

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What other outcomes are relevant?

Developed measures of: i) Practical wound management ii) Patient wound experience

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Feasibility study: Phase A & B

Feasibility Study (funded)

Phase A

Which interventions? What outcome measures? And other things….

Phase B

Pilot RCT

Phase C

Main RCT

Not (yet) funded

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Questions for the pilot RCT (Phase B)

  • Is it possible to recruit?
  • Is it practical & acceptable to randomise in theatre?
  • Is there adherence to the treatment allocation?
  • Can we validate the outcome measures?
  • Can we (and do we want to) design Phase C
  • Examine rates of SSI for types of dressing?
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Progress with pilot RCT

  • 136 screened
  • 95 (69%) eligible
  • 65 randomised
  • No cross overs
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Summary – benefits to P & F work

  • Non randomised feasibility work is an

essential precursor to definitive trials

  • Internal pilot– good idea for all/most trials
  • External pilot - if major uncertainties about

main trial

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Acknowledgements

  • The ROMIO, By-Band-Sleeve and Bluebelle studies are

funded by the NIHR HTA Programme (10/50/65, 14/140/78, 09/127/53 and 12/200/04 respectively)

  • The MRC ConDuCT-II Hub for Trials Methodology Research

(www.bristol.ac.uk/social-community-medicine/ centres/conduct2)

Department of Health Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR HTA, NHS or the Department of Health.

Email: j.m.blazeby@bris.ac.uk