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 journalArticlepeer-review

43 Citations (Scopus)
7 Downloads (Pure)


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 languageEnglish
Article number392
Number of pages9
Early online date4 Sept 2015
Publication statusPublished - 4 Sept 2015

Bibliographical note

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.


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


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