NDORMS, Kadoorie Centre, level 3, John Radcliffe Hospital, University of Oxford, Oxford, OX3 9DU, UK.
Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Trials. 2019 Aug 9;20(1):492. doi: 10.1186/s13063-019-3597-8.
Qualitative research has been used to explore patients' and healthcare professionals' experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury. Little research, however, has explored patients' and healthcare professionals' experiences of surgical RCTs in a trauma setting. This study aimed to understand patients' and staff's experiences of an orthopaedic trauma trial.
We carried out semi-structured interviews with 11 patients and 24 staff (10 surgeons and 14 research associates) participating in a UK multi-centre feasibility trial comparing intramedullary nails versus distal locking plates for fractures of the distal femur (TrAFFix). Interviews explored patients' experience of TrAFFix and their reason for participating and staffs' experience of recruiting to TrAFFix and trauma trials more generally. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using thematic analysis.
Three themes were identified. These were i) navigating research with patients after orthopaedic trauma, ii) knowing that it is the right decision and iii) making it work. These themes reflect: i) how research associates supported and guided patients through the consent process enabling them to participate, ii) the difficulty in engaging surgeons in a trial when individual equipoise and experience of the interventions are low despite the presence of community equipoise and iii) the way in which research teams worked together and encouraged the development of a research culture within the clinical teams in order to facilitate recruitment.
Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs supported patients to enable them to make a decision about participation and assisted in developing a research culture within the team by promoting studies and communicating research to clinical staff. Our findings also reinforce surgeons' difficulty with equipoise and suggest that accepting community equipoise could facilitate recruitment.
定性研究已被用于探索患者和医疗保健专业人员对手术随机对照试验（RCT）的体验。从这项研究中，已经确定了患者接受或拒绝参与的原因以及阻碍临床医生参与试验的因素。在创伤环境中，招募手术试验可能特别困难，因为患者可能需要紧急治疗，他们考虑自己的选择、提出问题和做出决定的能力可能会因受伤的影响而受到阻碍。然而，很少有研究探讨创伤环境中患者和医疗保健专业人员对手术 RCT 的体验。本研究旨在了解骨科创伤试验中患者和工作人员的经验。
我们对 11 名患者和 24 名工作人员（10 名外科医生和 14 名研究助理）进行了半结构化访谈，他们参与了一项英国多中心可行性试验，比较了髓内钉与远端锁定板治疗股骨远端骨折（TrAFFix）。访谈探讨了患者对 TrAFFix 的体验以及他们参与的原因，以及工作人员对参与 TrAFFix 和更广泛的创伤试验的经验。访谈进行了录音，并逐字记录下来。使用主题分析对抄本进行了分析。
确定了三个主题。这些主题是：i）在骨科创伤后与患者一起进行研究，ii）知道这是正确的决定，以及 iii）使其发挥作用。这些主题反映了：i）研究助理如何支持和引导患者完成同意过程，使他们能够参与，ii）尽管存在社区平衡，但由于个人平衡和对干预措施的经验较低，外科医生参与试验的难度，以及 iii）研究团队如何共同努力，并鼓励在临床团队中发展研究文化，以促进招募。
我们的研究结果突出了研究助理（RAs）在促进试验招募方面的关键作用。RAs 支持患者做出参与决策，并通过促进研究和向临床工作人员传达研究，协助团队发展研究文化。我们的研究结果还强化了外科医生在平衡方面的困难，并表明接受社区平衡可以促进招募。
