Research Output

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

  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.

  • Type:

    Article

  • Date:

    04 September 2015

  • Publication Status:

    Published

  • Publisher

    Springer Nature

  • DOI:

    10.1186/s13063-015-0918-4

  • Cross Ref:

    918

  • ISSN:

    1745-6215

  • Library of Congress:

    BJ Ethics

  • Dewey Decimal Classification:

    174 Occupational ethics

  • Funders:

    Medical Research Council

Citation

Blencowe, N. S., Brown, J. M., Cook, J. A., Metcalfe, C., Morton, D. G., Nicholl, J., …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(1), 392. doi:10.1186/s13063-015-0918-4

Authors

Keywords

Surgical trials, trial design, complex interventions, methodology, standardisation, adherence/fidelity, expertise

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    © 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 waiver
    (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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