WHY DON’T ORTHOPAEDIC SURGEONS DO RANDOMISED CONTROLLED TRIALS?

Abstract

Introduction and Aims: Randomised controlled trials (RCTs) are frequently presented as the best design for studies of treatment effect because they minimise bias from unknown confounders. But, very few have been performed in orthopaedic and trauma surgery in comparison to other areas of medicine. This study investigated the perceived obstacles to performing RCTs, in order to identify areas where novel aspects of study design may facilitate randomisation in orthopaedic research.

Method: A qualitative study was performed using a deliberate maximum variation sample of 24 orthopaedic surgeons from four countries, involved in all aspects of practice, teaching, research, research funding, ethical approval and publication. A semi-structured interview was used to explore surgeons’ perceptions of obstacles to performing RCTs. A computer-assisted framework approach was used to analyse transcripts of these interviews, and to identify consistent themes and connections between them.

Results: Thirty-four discrete obstacles to performing RCTs in trauma and orthopaedic surgery were identified and classified. Many of these fell into six main themes:

• A non-evaluative culture;

• Misunderstanding of the scientific basis of trial design;

• Lack of individual equipoise;

• The complexity of the relationship between patient and surgeon;

• Inadequate measures of outcome;

• Practical problems associated with long follow-up, clinical work load and lack of funding.

Conclusion: A complex set of perceived problems were identified. None of these problems is insurmountable. The performance of RCTs would be encouraged by development of a more evaluative culture, collaboration between surgeons and epidemiologists, and greater resources for, and commitment to, clinical research. Novel study designs to address lack of individual equipoise are possible and offer the prospect of much greater use of randomisation.