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

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.(Continued on next page)

Patient-reported outcomes of immediate implant-based breast reconstruction with and without biological or synthetic mesh

“…Ideally, a well designed pragmatic RCT is required to establish definitively which reconstructive technique is most clinically and cost effective, and provides the best outcomes for patients. The iBRA RCT acceptability study has suggested that a trial may be feasible 45 and the Best-BRA external pilot study (ISRCTN10081873) will determine whether it is possible to recruit patients to an RCT comparing prepectoral and subpectoral techniques before progressing to a definitive large-scale trial. Similar RCTs are underway in Europe, and will generate much needed evidence to support practice and policy.…”

Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy

“…The QRI will be implemented in two key phases—phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment and informed consent. This will be supplemented with upfront pre-emptive recruitment training in study set up, tailored to anticipated issues and informed by previous QRIs 42 52 55 68 69…”

“…53 While the majority of respondents felt that an appropriately designed RCT in IBBR may be possible, 51 qualitative interviews with key stakeholders identified a number of barriers to the successful conduct of a future trial. 52 These included limited understanding of a pragmatic study design and the role of randomisation in minimising bias, issues around clinician equipoise and aspects of surgical culture not being supportive of RCTs.…”

“…The UK iBRA study48 used mixed methods including a national practice questionnaire,49 50 a randomisation acceptability survey51 and semistructured interviews52 with key stakeholders to explore the most appropriate design for a future RCT. This work suggested that a well-designed trial would be feasible and that key areas of uncertainty included the use of biological versus synthetic mesh and prepectoral versus subpectoral implant positioning 51.…”

Patient Reported Outcome and Quality of Life After Delayed Breast Reconstruction - An RCT Comparing Different Reconstructive Methods in Radiated and Non-radiated Patients

“…Nonetheless, there is no consensus regarding how these outcomes should be evaluated. There are few studies providing high-quality evidence supporting the use of different techniques for breast reconstruction and it is well-known that it is challenging to conduct randomized clinical trials (RCTs) in breast reconstruction, mainly due to patients' and surgeons' preferences leading to recruitment difficulties 2 . Consequently, there are few RCTs comparing quality of life in different breast reconstruction techniques [3][4][5] .…”