Research

• HTMR Network
• Network projects
  • For grantees
• Working Groups
• Publications
• Stakeholders
• Clinical capacity building
• Trials Change Lives
• Studies Within a Trial

• Home
• HTMR Research
• Network projects

Workshop on Randomised Surgical Trials: Methods to Improve Recruitment and Study Design

• Date: September 1, 2011
• Venue: Royal College of Surgeons, London

Background

One of the main barriers to conducting surgical trials is ineffective recruitment. Slow recruitment delays trial progress, is expensive (requiring extensions) or it may lead to early stopping of a trial without the sample size target being achieved. There are also many examples of surgical trials thought to be too difficult to undertake because surgeons consider that recruitment is impossible.

This workshop was organised by the ConDuCT Hub, in collaboration with the Cambridge Biostatistics Hub, the NIHR National Working Party on Improving Recruitment to Interventional Trials and the Royal College of Surgeons of England. The event was chaired by Professor Jane Blazeby and Professor Dion Morton.

Aims

• To provide an educational workshop focusing on methodological issues around recruitment into surgical trials and related issues in design.
• To learn about the successes and failures of some existing RCTs in surgery and discuss common issues.
• To raise the profile of randomised controlled trials within the surgical research community and provide the opportunity for networking between surgeons and methodologists.

Click here to view the programme.

Summary

The workshop was attended by 170+ surgeons, methodologists, trialists, research nurses and patient representatives. Speakers shared their experiences, successes and obstacles to highlight the key issues around running surgical RCTs. Questions and comments from the audience led to discussion about how we can aim to improve this difficult and complex area of research.

Outputs

• Presentations raised awareness of trainee-led surgical research collaboratives and the benefit for including qualitative methods in the design and conduct of surgical trials.
• Current on-going trials were promoted with the potential to increase recruitment.
• An overview of the event will appear in a Virtual Edition of BJUI.org.
• Feedback supports plans for a second event focused on surgical RCTs.

Presentations

Slides / audio files of the presentations are available below.

Session 1

• Download the Session 1 audio file
  
• A multi-centre randomised evaluation of surgery with craniectomy for uncontrolled elevation of intra-cranial pressure
• The MAZE procedure as an adjunct to cardiac surgery in patients in AF: experience of recruitment in the AMAZE multicentre trial
• Recruitment to surgical trials in the head and neck specialties
• Impact of surgeons, patients and referral practices on recruitment in the CLASS trial
• Trainee-led collaborative research in surgery can improve participation and recruitment to surgical RCTs - lessons learnt from the ROSSINI Trial

Session 2

• Download the Session 2 audio file
  
• Involving surgeons, other specialists and trialists in the design and conduct of trials – experiences from ProtecT
• Uncertainty and patients' treatment preferences - preventing or facilitating recruitment?
• The new clinical research landscape - incentives, opportunities and support offered by the NIHR