Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

Abstract

Abstract Background Implant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals’ perceptions of future trials in IBBR. Findings from the interviews are presented here. Methods Semi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved. Results Almost all HPs acknowledged the need for better evidence to support the practice of IBBR and most identified RCTs as generating the highest-quality evidence. Despite highlighting potential challenges, most participants supported the need for an RCT in IBBR. A minority, however, were strongly opposed to a future trial. The opposition and challenges identified centred around three key themes; (i) limited understanding of pragmatic study design and the value of randomisation in minimising bias; (ii) clinician and patient equipoise and (iii) aspects of surgical culture and training that were not supportive of RCTs. Conclusion There is a need for well-designed, large-scale RCTs to support the current practice of IBBR but barriers to their acceptability are evident. The perceived barriers to RCTs in breast reconstruction identified in this study are not insurmountable and have previously been overcome in other similar surgical trials. This may represent an opportunity, not only to establish the evidence base for IBBR, but also to improve engagement in RCTs in breast surgery in general to ultimately improve outcomes for patients. Trial registration International Standard Randomised Controlled Trial Number ISRCTN37664281.