Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Trials Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study Shelley Potter 0 1 Nicola Mills 1 Simon J Cawthorn 2 Jenny Donovan 1 Jane M Blazeby 0 1 0 Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust , Upper Maudlin Street, Bristol BS2 8HW , UK 1 Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol , Canynge Hall, 39 Whatley Road, Bristol BS8 2PS , UK 2 Bristol Breast Care Centre, North Bristol NHS Trust, Southmead Hospital , Bristol BS10 5NB , UK Background: Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons' preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons' views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons' preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods: Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results: Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel 'in equipoise', they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion: There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required. Breast reconstruction; Education; Methodology; Qualitative; Randomised clinical trials - Background Patients and surgeons need high-quality information about treatment outcomes to inform decision-making [1]. It is increasingly recognised that well-designed randomised clinical trials (RCTs) provide the best evidence for the effectiveness of an intervention, and, although not suitable for addressing all research questions, they should be the default option for evaluating many, if not all, surgical procedures [2-4]. Surgical trials are difficult to conduct [5], however, and challenges in the implementation of well-designed, pragmatic, multicentre RCTs for surgical procedures have been well-documented [6-8]. Particular challenges relate to the preferences and beliefs of participating surgeons [5,9]. These factors may influence whether a trial is initiated [5], whether participants are recruited effectively [10] and whether the results are accepted and subsequently used to influence practice [3]. A particular challenge is encountered in the effective design and conduct of surgical RCTs in which there are several treatment options and in which patient and surgeon preferences play a key role in procedure selection and patient eligibility. Breast reconstruction (BR) after mastectomy for breast cancer is one such example, where possible interventions include simple implantbased reconstruction, pedicled flap reconstruction including the latissimus dorsi flap, or free flap procedures such as the deep inferior epigastric perforator (DIEP) flap using skin and fat from the lower abdominal wall [11,12]. Since 1995, just 13 BR RCTs [13-24] have been conducted and only 2 have addressed major questions such as the optimal type [24] or timing [25] of surgery. Both of these latter two trials were small, single-centre studies which failed to meet recruitment targets. Systematic reviews have summarised the randomised and nonrandomised evidence for BR surgery [26,27] and highlighted the lack of high-quality research in this area. Although many of the investigators of the nonrandomised studies commented on the limitations of their observational data and the hypothetical need for randomised trials [28-31], prevailing expert opinion suggests that RCTs in BR would be unethical, impractical and/or inappropriate [11,28-36] because of the importance of patient and surgeon preference in procedure selection. These claims and, more broadly, how surgeons preferences may influence participation in surgical trials in general have rarely been explored in depth. Qualitative interviews are an excellent method for exploring difficult or sensitive issues [37], such as the basis of surgeons preferences, and are increasingly used in the development of trial methodology [9,38]. Our aim in the Breast Reconstruction and Valid Evidence (BRAVE) study was therefore to use qualitative methods to explore surgeons preferences and beliefs to gain an understanding of how these factors may influence the feasibility of surgical RCTs using hypothetical trials in BR as a case study. Health-care professional recruitment Opinion leaders in BR surgery were hypothesised to be key informants regarding the feasibility of randomisation in BR because they would be most likely to participate in any future trial. Our sampling strategy therefore initially targeted surgeons practicing at high-volume centres offering advanced training fellowships. group outlining the study, and committee members were invited to participate. Surgeons from high-volume centres that were not represented at the meeting were sent personalised e-mail invitations. Other surgeons with potentially interesting views on randomisation who were recommended by key informants were similarly approached. Colleagues, clinical nurse specialists (CNSs) and psychologists at centres of consenting surgeons were also invited to participate. Nonrespondents were sent an electronic reminder after 3 weeks. Surgeons who did not respond thereafter were considered to have declined study participation. Maximum variation sampling [39] was initially employed such that male and female surgeons with a range of experience from different geographical and sociodemographic centres across the United Kingdom were initially included [40,41]. As the study progressed, theoretical sampling was introduced to purposively select individuals whose views might add new pe (...truncated)