如果招募试验参与者的临床医生不理解试验的真正内容，这有关系吗？关于外科医生参与一项实用多中心随机对照试验经历的定性研究。
Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT.
作者信息
Ziebland Sue, Featherstone Katie, Snowdon Claire, Barker Karen, Frost Helen, Fairbank Jeremy
机构信息
Department of Primary Health Care, University of Oxford, Oxford, UK.
出版信息
Trials. 2007 Jan 27;8:4. doi: 10.1186/1745-6215-8-4.
BACKGROUND
Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed.
METHODS
We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT) to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres.
RESULTS
Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice.
CONCLUSION
The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians) may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic design is not considered a design fault. We conclude that it does matter if clinicians do not understand the rationale for the trial if, as we have shown here, their perception of the trial aims and methods adversely affects who they recruit; if their views affect what the patients are told; and if they mistakenly view the results as unscientific, unreliable and ultimately irrelevant to their practice.
背景
定性方法越来越多地用于研究临床试验过程以及患者对试验基本原理、随机分组、参与或拒绝参与原因的理解。患者的理解不可避免地受到招募临床医生对试验理解的影响，但相对较少的定性研究探讨了临床医生对试验的看法和理解。本研究在多中心实用随机对照试验完成后不久对参与试验的外科医生进行了访谈。
方法
我们对参与脊柱稳定试验（一项实用随机对照试验）的外科医生进行了深入访谈，以探讨他们对试验目的的理解，以及这种理解如何影响他们的招募程序和对结果的解读。从英国15个试验中心中的8个中心选取了11名参与试验的外科医生作为有目的的样本。
结果
尽管外科医生认为该试验解决了一个重要问题，但对于这个问题是什么几乎没有达成共识：尽管这是一项“等效”治疗的试验，但一些人认为这是一项手术试验，另一些人认为是康复试验，还有一些人认为是在探索对所有其他治疗方案均无效的患者该如何处理。我们访谈的外科医生不知道实用纳入标准的基本原理，几乎所有人都对“ equipoise”（均势）的含义完全困惑。对入选标准的误解是对结果产生困惑的一个重要来源，并导致他们不愿将结果应用于自己的临床实践。
结论
该研究为未来多中心试验的开展提供了几点经验教训。招募外科医生（和其他临床医生）可能不熟悉实用设计的基本原理，可能需要在研究期间定期提醒他们试验目的。可能需要向他们保证实用设计并非设计缺陷。我们得出结论，如果临床医生不理解试验的基本原理，这确实很重要，因为正如我们在此处所示，如果他们对试验目的和方法的认知对他们招募的对象产生不利影响；如果他们对患者的告知产生影响；如果他们错误地认为结果不科学、不可靠且最终与他们的临床实践无关。
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