Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.
School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.
Emerg Med J. 2017 Sep;34(9):593-598. doi: 10.1136/emermed-2016-206073. Epub 2017 May 12.
As an important part of a pilot study to determine the feasibility of a large randomised controlled trial (RCT) comparing use of the Manchester Acute Coronary Syndromes (MACS) decision rule with standard care, we aimed to explore patient attitudes and potential barriers to participation in a trial of this nature.
We conducted a qualitative study nested within a pilot RCT comparing use of the MACS rule (which could enable some patients with chest pain to be discharged earlier) with standard care. Semi-structured interviews with consenting participants were conducted with reference to a bespoke topic guide. Interviews were audio recorded, transcribed verbatim and analysed using the Framework method with an inductive approach.
The 10 interviewees expressed that participation in the trial was generally acceptable. All but one recommended participation to others. Participants who were in pain or anxious at the time of arrival reported that the initial invitation to participate in the trial was sometimes made too early. The approach was welcome, providing they had been given time to settle. Interviewees welcomed the opportunity that trial participation offered for them to play a more active role in their healthcare and to reduce unnecessary waiting time. Participants appeared to like the fact that participation in the trial might mean they could return home sooner and welcomed the provision of follow-up. Although several participants described being generally sceptical of medical research, they were amenable to participation in this trial. This appears to be because they agreed with the need for research in this field and perceived the intervention as non-invasive.
Patients were positive about their participation in this RCT comparing the MACS rule with standard care. A number of areas for improving trial design were identified and should be considered in the planning of future large trials.
ISRCTN 86818215 RESEARCH ETHICS COMMITTEE REFERENCE: 13/NW/0081 UKCRN REGISTRATION ID: 14334.
作为一项旨在确定使用曼彻斯特急性冠状动脉综合征（MACS）决策规则与标准护理比较的大型随机对照试验（RCT）可行性的初步研究的重要组成部分，我们旨在探讨患者对参与此类试验的态度和潜在障碍。
我们在一项与使用 MACS 规则（可以使一些胸痛患者更早出院）与标准护理进行比较的试点 RCT 中进行了一项嵌套的定性研究。使用专门的主题指南对同意参与的参与者进行半结构化访谈。访谈进行了录音、逐字转录，并使用框架方法进行了分析，采用了归纳法。
10 名受访者表示，参与试验通常是可以接受的。除了一位之外，所有人都建议其他人参与。在到达时感到疼痛或焦虑的参与者报告说，最初邀请他们参与试验有时太早了。只要给他们时间安顿下来，这种方法是受欢迎的。受访者欢迎有机会在他们的医疗保健中扮演更积极的角色，并减少不必要的等待时间。参与者似乎喜欢参与试验可能意味着他们可以更早回家的事实，并欢迎提供后续服务。尽管一些参与者表示对医学研究普遍持怀疑态度，但他们愿意参与这项试验。这似乎是因为他们同意该领域研究的必要性，并认为干预措施是非侵入性的。
患者对他们参与这项与标准护理比较 MACS 规则的 RCT 持积极态度。确定了一些改进试验设计的领域，应在未来的大型试验规划中加以考虑。
ISRCTN 86818215 研究伦理委员会参考：13/NW/0081 UKCRN 注册号：14334。
