外科随机对照试验中的干预措施:试验设计过程中需考虑的问题。
Interventions in randomised controlled trials in surgery: issues to consider during trial design.
作者信息
Blencowe Natalie S, Brown Julia M, Cook Jonathan A, Metcalfe Chris, Morton Dion G, Nicholl Jon, Sharples Linda D, Treweek Shaun, Blazeby Jane M
机构信息
Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK.
Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
出版信息
Trials. 2015 Sep 4;16:392. doi: 10.1186/s13063-015-0918-4.
Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.
直到最近,人们对手术干预很复杂这一事实的关注仍不够充分。这种复杂性有多种影响,包括在试验中描述和实施手术干预的方式。为了让外科医生采用试验结果,干预措施需要详细描述,以便能够准确复制;然而,某些方面根据当地实践进行实施可能是允许的。该领域不断积累的工作已确定,在试验方案和报告中,需要针对手术干预的设计提供一般性指导。设计手术干预时要考虑的关键问题包括确定每项手术干预及其组成部分、谁将实施干预,以及在试验期间干预措施将在何处以及如何进行标准化和监测。试验设计(务实性和解释性)、对照物和创新阶段也可能影响所需细节的程度。以这种方式对手术干预进行深入思考,可能有助于解释试验结果,并将成功的干预措施应用于临床实践。