Interventions in randomised controlled trials in surgery: issues to consider during trial design

Natalie S Blencowe; Julia M Brown; Jonathan A Cook; Chris Metcalfe; Dion G Morton; Jon Nicholl; Linda D Sharples; Shaun Treweek; Jane M Blazeby; Members of the MRC Hub for Trials Methodology Research Network Workshop

doi:10.1186/s13063-015-0918-4

Interventions in randomised controlled trials in surgery: issues to consider during trial design

Natalie S Blencowe, Julia M Brown, Jonathan A Cook, Chris Metcalfe, Dion G Morton, Jon Nicholl, Linda D Sharples, Shaun Treweek, Jane M Blazeby, Members of the MRC Hub for Trials Methodology Research Network Workshop

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

46 Citations (Scopus)

7 Downloads (Pure)

Abstract

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

Original language	English
Article number	392
Number of pages	9
Journal	Trials
Volume	16
Early online date	4 Sept 2015
DOIs	https://doi.org/10.1186/s13063-015-0918-4
Publication status	Published - 4 Sept 2015

Bibliographical note

Acknowledgements
This work was supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1-R/N29), the MRC ConDuCT Hub (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures - MR/K025643/1) and the MRC Biostatistics Hub (Cambridge). NSB is an NIHR Academic Clinical Lecturer. This paper presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. JAC holds a Medical Research Council UK Methodology fellowship (G1002292). The Health Services Research Unit at the University of Aberdeen is funded by the Chief
Scientist Office of the Scottish Government Health Directorates.

Keywords

surgical trials
trial design
complex interventions
methodology
standardisation
adherence/fidelity
expertise

Access to Document

10.1186/s13063-015-0918-4Licence: CC BY

Blencowe 2015
© 2015 Blencowe et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waive (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 467 KBLicence: CC BY

Cite this

Blencowe, N. S., Brown, J. M., Cook, J. A., Metcalfe, C., Morton, D. G., Nicholl, J., Sharples, L. D., Treweek, S., Blazeby, J. M., & Members of the MRC Hub for Trials Methodology Research Network Workshop (2015). Interventions in randomised controlled trials in surgery: issues to consider during trial design. Trials, 16, Article 392. https://doi.org/10.1186/s13063-015-0918-4

@article{90be1920e5c0475397e85f57f831a0aa,

title = "Interventions in randomised controlled trials in surgery: issues to consider during trial design",

abstract = "Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.",

keywords = "surgical trials, trial design, complex interventions, methodology, standardisation, adherence/fidelity, expertise",

author = "Blencowe, {Natalie S} and Brown, {Julia M} and Cook, {Jonathan A} and Chris Metcalfe and Morton, {Dion G} and Jon Nicholl and Sharples, {Linda D} and Shaun Treweek and Blazeby, {Jane M} and {Members of the MRC Hub for Trials Methodology Research Network Workshop}",

note = "Acknowledgements This work was supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1-R/N29), the MRC ConDuCT Hub (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures - MR/K025643/1) and the MRC Biostatistics Hub (Cambridge). NSB is an NIHR Academic Clinical Lecturer. This paper presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. JAC holds a Medical Research Council UK Methodology fellowship (G1002292). The Health Services Research Unit at the University of Aberdeen is funded by the Chief Scientist Office of the Scottish Government Health Directorates.",

year = "2015",

month = sep,

day = "4",

doi = "10.1186/s13063-015-0918-4",

language = "English",

volume = "16",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

}

TY - JOUR

T1 - Interventions in randomised controlled trials in surgery

T2 - issues to consider during trial design

AU - Blencowe, Natalie S

AU - Brown, Julia M

AU - Cook, Jonathan A

AU - Metcalfe, Chris

AU - Morton, Dion G

AU - Nicholl, Jon

AU - Sharples, Linda D

AU - Treweek, Shaun

AU - Blazeby, Jane M

AU - Members of the MRC Hub for Trials Methodology Research Network Workshop

N1 - Acknowledgements This work was supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1-R/N29), the MRC ConDuCT Hub (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures - MR/K025643/1) and the MRC Biostatistics Hub (Cambridge). NSB is an NIHR Academic Clinical Lecturer. This paper presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. JAC holds a Medical Research Council UK Methodology fellowship (G1002292). The Health Services Research Unit at the University of Aberdeen is funded by the Chief Scientist Office of the Scottish Government Health Directorates.

PY - 2015/9/4

Y1 - 2015/9/4

N2 - Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

AB - Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

KW - surgical trials

KW - trial design

KW - complex interventions

KW - methodology

KW - standardisation

KW - adherence/fidelity

KW - expertise

U2 - 10.1186/s13063-015-0918-4

DO - 10.1186/s13063-015-0918-4

M3 - Article

C2 - 26337522

SN - 1745-6215

VL - 16

JO - Trials

JF - Trials

M1 - 392

ER -

Interventions in randomised controlled trials in surgery: issues to consider during trial design

Abstract

Bibliographical note

Keywords

Access to Document

Fingerprint

Cite this