Surgical interventions should be evaluated in the context of well-designed, pragmatic, multicentre RCTs because high-quality evidence can guide health policy and clinical decision-making and provide a standard of care for patients considering surgery. Surgical trials are challenging, however, and surgeons’ preferences are an established barrier to their participation and recruitment of patients into trials [7, 54]. Our present exploratory, qualitative study including 35 professionals produces further evidence that surgeons do not always accept RCTs or the results. It also provides new data suggesting that surgeons’ rejection of this methodology may be related to their limited understanding of the importance of randomisation in allowing the outcomes of surgical procedures to be fully evaluated, as well as pragmatic trial design issues. Interventions designed to improve professionals’ understanding of the need for trials and pragmatic trial methodology are therefore recommended.
Surgeons’ preferences are a well-recognised and accepted barrier to their participation in trials [10, 55–58] but investigators in previous studies have not tried to understand these preferences, how they are formed or the evidence on which they are based, although there is some data to suggest that surgeons’ understanding is limited . By contrast, several studies have explored the basis of patients’ treatment preferences [59–62]. Training research nurse trial recruiters to explore patients’ preferences has been shown to facilitate recruitment of participants into a RCT of watchful waiting, radical radiotherapy and surgery in patients with early prostate cancer . It is possible that such an intervention might be effective in aiding surgeons to recruit patients into RCTs. The limited understanding of pragmatic trial methodology identified in this study is consistent with the findings of a similar previous study conducted with surgeons who had participated in the Spinal Stabilisation Trial (SST) , a multicentre, pragmatic RCT comparing an intensive functional rehabilitation programme with surgery for the treatment of chronic lower-back pain. In accordance with the views of the participants in the present study, surgeons recruiting patients into the SST were unsure about the study’s aims or the nature of the comparisons and expressed concerns about the flexible eligibility criteria, which they felt would invalidate the study’s final results. These views had a negative impact on both recruitment during the study and acceptance and interpretation of the study findings. Therefore, a growing body of evidence suggests that surgeons may have a limited understanding of trial methodology.
Although our present study is novel, it may not reflect the true acceptability of RCTs to surgeons, because participants were asked to consider hypothetical trial participation. The similarities between the findings of this study and the SST, however, suggest that the presence of this potential weakness is unlikely. It is also possible that the researcher shaped the study in that, by knowing they were speaking with a physician, the surgeons responded in a particular way. Several strategies were used to ensure the validity of the study data [42, 49] and reduce the risk of bias [40, 42, 44, 49–52]. These approaches included triangulation of the health professionals’ views , multiple coding of transcripts  and checking of data interpretation by the research team. Throughout the study, care was taken to ensure the inclusion of negative cases and the use of ‘fair dealing’, such that multiple differing perspectives have been reported and the viewpoint of only one group has not been presented as the sole truth . Particular attention was paid to the issue of reflexivity and the way in which the researcher, a female medically qualified general surgical trainee (SP) with clinical and research experience with BR, may have shaped the data collection and analysis, as well as how this factor might potentially have influenced the presentation of the results . A clear and comprehensive description of the methods of data collection and analysis have been provided with a range of quotations to illustrate the themes and theories discussed, thus allowing readers to judge for themselves whether the conclusions drawn are adequately supported by the data . Although this study involved surgeons who perform BR surgery, the findings may apply to surgeons in general and may provide novel insights into the ways in which recruitment into surgical trials may be improved.
Well-designed RCTs in surgery are vital to generate high-quality data to guide decision-making, and it is essential that future RCTs be conducted to rigorously evaluate new surgical innovations [2, 4] before the procedures are introduced into routine practice. This consideration is of particular importance in operations such as BR, where available procedures differ markedly in cost and evidentiary proof of effectiveness or superiority are necessary to justify diversion of scarce resources to the use of novel techniques while protecting patients from potential harm .
RCTs are traditionally unfamiliar to surgeons, however . Unlike drugs, which require robust evaluation before they are approved for use, there are no stringent requirements for the introduction of new procedures in surgery [66–71]. Infrastructure to facilitate high-quality surgical research has also been lacking. There has therefore been little impetus for surgeons to engage in time-consuming and often challenging research [4, 5, 7, 8, 72–75], and many early trials failed because of poor recruitment . Embedding qualitative research into surgical trial design is one way in which these problems may be successfully explored and overcome [38, 76]. By highlighting previously unanticipated issues relating to a lack of understanding of both the need for RCTs and the role of pragmatic study methodology, however, this study may have identified a potentially novel target for interventions to improve participation in surgical trials: the surgeons themselves.
Integrating education within trials may be one way in which this goal may be achieved , but changing the culture of surgical research, creating research capacity and educating the next generation of surgeons about the need for and value of RCTs as a fundamental part of their training may be the most effective long-term strategy for improving recruitment into future surgical trials [5, 54]. The Royal College of Surgeons of England recently published a number of recommendations regarding the future of surgical research  and initiated plans to create a surgical trials infrastructure through the creation of an Institute of Surgical Research and regional trials units . Integral to these changes is the incorporation of research modules into surgical training . In time, implementation of these recommendations may address some of the issues relating to the lack of familiarity with trial methodology identified in this study and help to ensure that surgical trials are better accepted. An apprenticeship model of ‘see one, do one, teach one’ may be a starting place to change the culture of trial participation by surgeons.
Indeed, there is already evidence that the culture of surgical research in the United Kingdom is changing with the rise of the surgical trainee research collaboratives. The trainee collaborative concept, which originated in the West Midlands has been rapidly disseminated throughout the United Kingdom, and subspecialty collaboratives in orthopaedic and plastic surgery and neurosurgery have also been established [79, 80]. The innovative model of trainees at different hospitals working together has been shown to be an effective and efficient means of delivering large, multicentre audit projects  and high-quality surgical trials . Trainees are highly motivated to participate in such studies and gain familiarity with research methodology as well as developing valuable practical research skills such as recruiting patients into trials. As such, trainee networks have the potential to build research capacity and make a significant contribution to clinical research .
For surgical trainees to be fully engaged with this model, however, changes are required in the way in which research participation and achievements are assessed, both during and at the end of training. The current need to generate academic output for career progression has hindered participation in high-quality clinical research because trainees’ efforts have been diverted into writing up case reports and case series with little awareness of their methodological limitations or toward pursuing more traditional laboratory-based projects in which the required outputs are more easily achieved. Moves are underway to address this issue, and evidence of recruitment of patients into surgical trials and participation in collaborative clinical research, rather than the number of publications, are likely to become minimum future requirements for completion of surgical specialist training.