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Related Experiment Video

Updated: Jan 4, 2026

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Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial.

Katie Biggs1, Daniel Hind2, Mike Bradburn2

  • 1Sheffield Clinical Trials Research Unit (CTRU), University of Sheffield, Regent Court, Sheffield, S1 4DA, UK. C.E.Biggs@sheffield.ac.uk.

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Summary
This summary is machine-generated.

Conducting pragmatic randomized controlled trials for surgical interventions requires careful planning for recruitment and retention. This study outlines strategies, including forecasting and staff training videos, to successfully meet trial objectives.

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Area of Science:

  • Surgical Trials
  • Clinical Trial Methodology
  • Pragmatic Research

Background:

  • Pragmatic randomized controlled trials (RCTs) are increasingly used for surgical interventions.
  • These trials face unique challenges in patient recruitment and retention.

Purpose of the Study:

  • To discuss the implementation of a multi-centre pragmatic surgical RCT.
  • To present strategies for overcoming recruitment and retention challenges in surgical trials.

Main Methods:

  • Forecasting consent rates and micro-costing study activities.
  • Developing a recruitment video for study staff.
  • Monitoring attrition due to procedure waiting times and triangulating outcome data.

Main Results:

  • Forecasting and costing ensured adequate recruitment time and resources.
  • The recruitment video was found useful by staff.
  • Strategies effectively ensured adequate follow-up of randomized participants.

Conclusions:

  • The study successfully met its objectives using evidence-based and experience-based approaches.
  • Lessons learned are transferable to future pragmatic surgical RCTs.