Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study

Natalie S. Blencowe; Anni Skilton; Daisy Gaunt; Rachel Brierley; Andrew Hollowood; Simon Dwerryhouse; Simon Higgs; William Robb; Alex Boddy; George Hanna; C. Paul Barham; Jane Blazeby; Chris Metcalfe; Jenny Donovan; Newton Wong; Richard Berrisford; Benjamin Howes; William Hollingworth; Chris Rogers; Kerry Avery; Jackie Elliott; Lucy Culliford; Marcus Jepson; Peter Lamb; Ravinder Vohra; JamesCatton; Rachel Melhado; Kish Pursani; Richard Krysztopik; James Byrne; Bilal Alkhaffaf; Tim Underwood; PaulWilkerson; Christopher Streets; Dan Titcomb; Richard Berrisford; Lee Humphreys; Tim Wheatley; Grant Sanders; Arun Ariyarathenam; James Byrne; Jamie Kelly; FergusNoble; Graeme Couper; Richard Skipworth; Chris Deans; Anna Paisley; Sukhir Ubhi; Rob Williams; David Bowrey; David Exon; Paul Turner; Vinutha Shetty; RamChaparala; Khurshid Akhtar; Siba Senapati; Simon Parsons; Neil Welch; NaheedFarooq

doi:10.1136/bmjopen-2018-026209

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study

Natalie S. Blencowe, Anni Skilton, Daisy Gaunt, Rachel Brierley, Andrew Hollowood, Simon Dwerryhouse, Simon Higgs, William Robb, Alex Boddy, George Hanna, C. Paul Barham, Jane Blazeby, Chris Metcalfe, Jenny Donovan, Newton Wong, Richard Berrisford, Benjamin Howes, William Hollingworth, Chris Rogers, Kerry AveryJackie Elliott, Lucy Culliford, Marcus Jepson, Peter Lamb, Ravinder Vohra, JamesCatton, Rachel Melhado, Kish Pursani, Richard Krysztopik, James Byrne, Bilal Alkhaffaf, Tim Underwood, PaulWilkerson, Christopher Streets, Dan Titcomb, Richard Berrisford, Lee Humphreys, Tim Wheatley, Grant Sanders, Arun Ariyarathenam, James Byrne, Jamie Kelly, FergusNoble, Graeme Couper, Richard Skipworth, Chris Deans, Anna Paisley, Sukhir Ubhi, Rob Williams, David Bowrey, David Exon, Paul Turner, Vinutha Shetty, RamChaparala, Khurshid Akhtar, Siba Senapati, Simon Parsons, Neil Welch, NaheedFarooq

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in ‘real world’ settings), compared with explanatory trials (which are smaller and more tightly controlled).

Objective This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.

Methods and analysis We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.

Ethics and dissemination Ethics approval was obtained (NRES Committee South West—Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.

Trial registration number ISRCTN59036820, ISRCTN10386621.

Original language	English
Journal	BMJ Open
Volume	9
Issue number	3
DOIs	https://doi.org/10.1136/bmjopen-2018-026209
Publication status	Published - 1 Mar 2019

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Manchester Cancer Research Centre

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10.1136/bmjopen-2018-026209

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Blencowe, N. S., Skilton, A., Gaunt, D., Brierley, R., Hollowood, A., Dwerryhouse, S., Higgs, S., Robb, W., Boddy, A., Hanna, G., Barham, C. P., Blazeby, J., Metcalfe, C., Donovan, J., Wong, N., Berrisford, R., Howes, B., Hollingworth, W., Rogers, C., ... NaheedFarooq (2019). Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study. BMJ Open, 9(3). https://doi.org/10.1136/bmjopen-2018-026209

@article{b542c731765b452196fc1fa30a615a9c,

title = "Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study",

abstract = "Introduction Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in {\textquoteleft}real world{\textquoteright} settings), compared with explanatory trials (which are smaller and more tightly controlled).Objective This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.Methods and analysis We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.Ethics and dissemination Ethics approval was obtained (NRES Committee South West—Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.Trial registration number ISRCTN59036820, ISRCTN10386621.",

author = "Blencowe, {Natalie S.} and Anni Skilton and Daisy Gaunt and Rachel Brierley and Andrew Hollowood and Simon Dwerryhouse and Simon Higgs and William Robb and Alex Boddy and George Hanna and Barham, {C. Paul} and Jane Blazeby and Chris Metcalfe and Jenny Donovan and Newton Wong and Richard Berrisford and Benjamin Howes and William Hollingworth and Chris Rogers and Kerry Avery and Jackie Elliott and Lucy Culliford and Marcus Jepson and Peter Lamb and Ravinder Vohra and JamesCatton and Rachel Melhado and Kish Pursani and Richard Krysztopik and James Byrne and Bilal Alkhaffaf and Tim Underwood and PaulWilkerson and Christopher Streets and Dan Titcomb and Richard Berrisford and Lee Humphreys and Tim Wheatley and Grant Sanders and Arun Ariyarathenam and James Byrne and Jamie Kelly and FergusNoble and Graeme Couper and Richard Skipworth and Chris Deans and Anna Paisley and Sukhir Ubhi and Rob Williams and David Bowrey and David Exon and Paul Turner and Vinutha Shetty and RamChaparala and Khurshid Akhtar and Siba Senapati and Simon Parsons and Neil Welch and NaheedFarooq",

year = "2019",

month = mar,

day = "1",

doi = "10.1136/bmjopen-2018-026209",

language = "English",

volume = "9",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ ",

number = "3",

}

Blencowe, NS, Skilton, A, Gaunt, D, Brierley, R, Hollowood, A, Dwerryhouse, S, Higgs, S, Robb, W, Boddy, A, Hanna, G, Barham, CP, Blazeby, J, Metcalfe, C, Donovan, J, Wong, N, Berrisford, R, Howes, B, Hollingworth, W, Rogers, C, Avery, K, Elliott, J, Culliford, L, Jepson, M, Lamb, P, Vohra, R, JamesCatton, Melhado, R, Pursani, K, Krysztopik, R, Byrne, J, Alkhaffaf, B, Underwood, T, PaulWilkerson, Streets, C, Titcomb, D, Berrisford, R, Humphreys, L, Wheatley, T, Sanders, G, Ariyarathenam, A, Byrne, J, Kelly, J, FergusNoble, Couper, G, Skipworth, R, Deans, C, Paisley, A, Ubhi, S, Williams, R, Bowrey, D, Exon, D, Turner, P, Shetty, V, RamChaparala, Akhtar, K, Senapati, S, Parsons, S, Welch, N & NaheedFarooq 2019, 'Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study', BMJ Open, vol. 9, no. 3. https://doi.org/10.1136/bmjopen-2018-026209

TY - JOUR

T1 - Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study

AU - Blencowe, Natalie S.

AU - Skilton, Anni

AU - Gaunt, Daisy

AU - Brierley, Rachel

AU - Hollowood, Andrew

AU - Dwerryhouse, Simon

AU - Higgs, Simon

AU - Robb, William

AU - Boddy, Alex

AU - Hanna, George

AU - Barham, C. Paul

AU - Blazeby, Jane

AU - Metcalfe, Chris

AU - Donovan, Jenny

AU - Wong, Newton

AU - Berrisford, Richard

AU - Howes, Benjamin

AU - Hollingworth, William

AU - Rogers, Chris

AU - Avery, Kerry

AU - Elliott, Jackie

AU - Culliford, Lucy

AU - Jepson, Marcus

AU - Lamb, Peter

AU - Vohra, Ravinder

AU - JamesCatton,

AU - Melhado, Rachel

AU - Pursani, Kish

AU - Krysztopik, Richard

AU - Byrne, James

AU - Alkhaffaf, Bilal

AU - Underwood, Tim

AU - PaulWilkerson,

AU - Streets, Christopher

AU - Titcomb, Dan

AU - Berrisford, Richard

AU - Humphreys, Lee

AU - Wheatley, Tim

AU - Sanders, Grant

AU - Ariyarathenam, Arun

AU - Byrne, James

AU - Kelly, Jamie

AU - FergusNoble,

AU - Couper, Graeme

AU - Skipworth, Richard

AU - Deans, Chris

AU - Paisley, Anna

AU - Ubhi, Sukhir

AU - Williams, Rob

AU - Bowrey, David

AU - Exon, David

AU - Turner, Paul

AU - Shetty, Vinutha

AU - RamChaparala,

AU - Akhtar, Khurshid

AU - Senapati, Siba

AU - Parsons, Simon

AU - Welch, Neil

AU - NaheedFarooq,

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Introduction Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in ‘real world’ settings), compared with explanatory trials (which are smaller and more tightly controlled).Objective This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.Methods and analysis We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.Ethics and dissemination Ethics approval was obtained (NRES Committee South West—Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.Trial registration number ISRCTN59036820, ISRCTN10386621.

AB - Introduction Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in ‘real world’ settings), compared with explanatory trials (which are smaller and more tightly controlled).Objective This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.Methods and analysis We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.Ethics and dissemination Ethics approval was obtained (NRES Committee South West—Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.Trial registration number ISRCTN59036820, ISRCTN10386621.

U2 - 10.1136/bmjopen-2018-026209

DO - 10.1136/bmjopen-2018-026209

M3 - Article

SN - 2044-6055

VL - 9

JO - BMJ Open

JF - BMJ Open

IS - 3

ER -

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study

Abstract

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