Surgeons' and methodologists' perceptions of utilising an expertise-based randomised controlled trial design: a qualitative study.
Surgeons' and methodologists' perceptions of utilising an expertise-based randomised controlled trial design: a qualitative study.
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外科医生和方法学家对利用基于专业知识的随机对照试验设计的看法：一项定性研究。
DOI：
10.1186/s13063-018-2832-z
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发表时间：
2018-09-06
期刊：
影响因子：
2.5
通讯作者：
Skea Z
中科院分区：
文献类型：
--
作者：
Cook JA;Campbell MK;Gillies K;Skea Z
随机对照试验（RCT）被广泛认为是测试新的和新兴的临床干预措施的最严格方法。然而，当研究中的干预措施是两种不同的外科手术时，外科医生需要接受培训，并充分精通不同的手术方法才能参加这样的试验。通常情况下，即使外科医生可以进行两种试验外科手术，他们也会偏好其中一种手术和/或在其中一种手术中拥有更多的专业知识。基于专业知识的试验设计，参与的外科医生只提供他们有适当专业知识的程序，已被提出来克服这个问题。基于专业知识的设计何时应该得到最好的使用仍然不清楚;这种方法可能更适合于解决具体问题。这项定性研究的目的是提高对外科医生和方法学家关于使用基于专业知识的RCT设计的观点范围的理解。与外科医生和方法学家进行了12次单独访谈，他们有手术试验的经验。访谈是半结构化的，面对面或通过电话进行。对访谈进行了录音、转录，并采用解释性方法进行了系统分析。外科医生和方法学家都看到了基于专业知识的设计的潜在优势，特别是在外科医生的参与和正在评估的程序显着不同的试验方面。发现的主要缺点是方法学（例如，外科医生执行一项试验程序的可能性系统性不同）和操作（例如，需要在外科医生之间“转移”患者，可能会对外科医生/患者关系产生影响）。这项研究表明，在某些情况下，基于专业知识的试验设计具有增加外科医生参与试验的显著潜力。在其他情况下，标准设计通常被视为更可取的设计。基于专业知识的设计的特别合适的条件包括：所评价的外科手术实质上不同，由不同的卫生专业人员/外科医生常规提供，每个人都有明确的专业知识;以及使用多名外科医生模型，患者和外科医生之间的信任可以得到适当保护的情况。大多数参与者将标准设计视为默认设计。在基于专门知识的设计可能得到更广泛的采用之前，仍有一些后勤和方法上的关切问题有待解决。本文的在线版本（10.1186/s13063-018-2832-z）包含补充材料，可供授权用户使用。
Randomised controlled trials (RCTs) are widely recognised to be the most rigorous way to test new and emerging clinical interventions. When the interventions under study are two different surgical procedures, however, surgeons are required to be trained and sufficiently proficient in the different surgical approaches to take part in such a trial. It is often the case that even where surgeons can perform both trial surgical procedures, they have a preference and/or have more expertise in one of the procedures. The expertise-based trial design, where participating surgeons only provide the procedure in which they have appropriate expertise, has been proposed to overcome this problem. When expertise-based designs should be best used remains unclear; such approaches may be more suited to addressing specific questions. The aim of this qualitative study was to improve understanding about the range of views that surgeons and methodologists have regarding the use of the expertise-based RCT design. Twelve individual interviews with surgeons and methodologists with experience of surgical trials were conducted. Interviews were semi-structured and conducted face-to-face or by telephone. Interviews were audio-recorded, transcribed and analysed systematically using an interpretive approach. Both surgeons and methodologists saw potential advantages in the expertise-based design particularly in terms of surgeons’ participation and in trials where the procedures being evaluated were significantly different. The main disadvantages identified were methodological (e.g. the potential for surgeons carrying out one of the trial procedure being systematically different) and operational (e.g. the need to ‘transfer’ patients between surgeons with potential consequences for the surgeon/patient relationship). This study suggests that the expertise-based trial design has significant potential to increase surgeon participation in trials in some settings. In other settings the standard design was generally seen as the preferable design. Particularly suitable conditions for an expertise-based design include those where the surgical procedures under evaluation are substantially different, where they are routinely delivered by different health professionals/surgeons with clear proficiencies in each; and contexts in which a multiple-surgeon model is in use and trust between the patient and surgeons can be suitably protected. The standard design was seen by most participants as the default design. Several logistical and methodological concerns remain to be addressed before the expertise-based design is likely to be more widely adopted. The online version of this article (10.1186/s13063-018-2832-z) contains supplementary material, which is available to authorized users.
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4.2
作者：
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