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

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...

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Autores principales: Blencowe, Natalie S, Skilton, Anni, Gaunt, Daisy, Brierley, Rachel, Hollowood, Andrew, Dwerryhouse, Simon, Higgs, Simon, Robb, William, Boddy, Alex, Hanna, George, Barham, C Paul, Blazeby, Jane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429900/
https://www.ncbi.nlm.nih.gov/pubmed/30826769
http://dx.doi.org/10.1136/bmjopen-2018-026209
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author Blencowe, Natalie S
Skilton, Anni
Gaunt, Daisy
Brierley, Rachel
Hollowood, Andrew
Dwerryhouse, Simon
Higgs, Simon
Robb, William
Boddy, Alex
Hanna, George
Barham, C Paul
Blazeby, Jane
author_facet Blencowe, Natalie S
Skilton, Anni
Gaunt, Daisy
Brierley, Rachel
Hollowood, Andrew
Dwerryhouse, Simon
Higgs, Simon
Robb, William
Boddy, Alex
Hanna, George
Barham, C Paul
Blazeby, Jane
author_sort Blencowe, Natalie S
collection PubMed
description 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.
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spelling pubmed-64299002019-04-05 Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study Blencowe, Natalie S Skilton, Anni Gaunt, Daisy Brierley, Rachel Hollowood, Andrew Dwerryhouse, Simon Higgs, Simon Robb, William Boddy, Alex Hanna, George Barham, C Paul Blazeby, Jane BMJ Open Surgery 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. BMJ Publishing Group 2019-03-01 /pmc/articles/PMC6429900/ /pubmed/30826769 http://dx.doi.org/10.1136/bmjopen-2018-026209 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Surgery
Blencowe, Natalie S
Skilton, Anni
Gaunt, Daisy
Brierley, Rachel
Hollowood, Andrew
Dwerryhouse, Simon
Higgs, Simon
Robb, William
Boddy, Alex
Hanna, George
Barham, C Paul
Blazeby, Jane
Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
title Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
title_full Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
title_fullStr Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
title_full_unstemmed Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
title_short Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
title_sort protocol for developing quality assurance measures to use in surgical trials: an example from the romio study
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429900/
https://www.ncbi.nlm.nih.gov/pubmed/30826769
http://dx.doi.org/10.1136/bmjopen-2018-026209
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