Blencowe, N.S., Brown, J.M., Cook, J.A. et al. (7 more authors) (2015) Interventions in randomised controlled trials in surgery: issues to consider during trial design. Trials, 16. 392. ISSN 1745-6215
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2015 Blencowe et al. 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 waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Surgical trials; Trial design; Complex interventions; Methodology; Standardisation; Adherence/fidelity; Expertise |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 04 May 2017 10:57 |
Last Modified: | 23 Jun 2017 15:49 |
Published Version: | https://doi.org/10.1186/s13063-015-0918-4 |
Status: | Published |
Publisher: | BioMed Central |
Refereed: | Yes |
Identification Number: | 10.1186/s13063-015-0918-4 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:115417 |