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Surgeons' and methodologists' perceptions of utilising an expertise-based randomised controlled trial design: a
Jonathan A Cook1,2, Marion K Campbell3, Katie Gillies3
1Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Rd, Oxford, OX3 7LD, UK. jonathan.cook@ndorms.ox.ac.uk.
Trials
|September 8, 2018
Summary
The expertise-based trial design can improve surgeon participation in clinical trials, especially for significantly different surgical procedures. However, methodological and operational challenges need addressing before wider adoption.
Area of Science:
- Clinical Trials Methodology
- Surgical Research Design
- Qualitative Research in Medicine
Background:
- Randomised controlled trials (RCTs) are the gold standard for testing clinical interventions.
- Surgical RCTs face challenges when surgeons must be proficient in multiple procedures.
- The expertise-based trial design allows surgeons to participate using their preferred procedure.
Purpose of the Study:
- To explore surgeon and methodologist views on expertise-based RCT designs.
- To understand the suitability and challenges of expertise-based trial designs in surgical research.
Main Methods:
- Conducted 12 semi-structured individual interviews with surgeons and methodologists experienced in surgical trials.
- Interviews were conducted face-to-face or via telephone.
- Data were systematically analyzed using an interpretive approach after transcription.
Main Results:
- Both groups saw advantages in expertise-based designs for surgeon participation and trials with distinct procedures.
- Identified disadvantages included methodological concerns (systematic differences between surgeons) and operational issues (patient transfer).
- The design is potentially beneficial when procedures are substantially different and performed by different specialists.
Conclusions:
- Expertise-based RCTs can enhance surgeon participation in specific surgical trial settings.
- The standard RCT design remains the preferred default in many situations.
- Further work is needed to address logistical and methodological concerns for broader adoption.