The challenges faced in the design, conduct and analysis of surgical randomised controlled trials.
The challenges faced in the design, conduct and analysis of surgical randomised controlled trials.
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DOI：
10.1186/1745-6215-10-9
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发表时间：
2009-02-06
期刊：
影响因子：
2.5
通讯作者：
Cook JA
中科院分区：
文献类型：
--
作者：
Cook JA
对手术干预的随机评估很少见；一些干预措施未经严格评估就被广泛采用。与其他医学领域不同，随机对照试验（RCT）设计尚未成为评估手术干预措施的默认研究设计。手术试验很难成功进行，并且带来了特殊的实践和方法学挑战。然而，随机对照试验在评估外科创新方面发挥了作用，并且有更大的应用范围和需要。本文将考虑外科干预的随机对照试验的设计、实施和分析。这些问题将在三个标题下进行审查：评估时间、定义研究问题和试验设计问题。就未来进行外科随机对照试验提出了建议。研究和外科界之间需要合作，以解决外科干预评估所提出的独特问题，并能够进行适当和精心设计的试验。
Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials.
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DOI：
10.1191/1740774504cn042oa
发表时间：
2004-01-01
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Cook, Jonathan A;Ramsay, Craig R;Fayers, Peter
通讯作者：
Fayers, Peter
影响因子：
4.1
作者：
BYER, A
通讯作者：
BYER, A
DOI：
10.1017/s026646230705163x
发表时间：
2007-12-01
影响因子：
3.2
作者：
Campbell, William Bruce;Barnes, Steven J.;Lyratzopoulos, Georgios
通讯作者：
Lyratzopoulos, Georgios
DOI：
10.2106/00004623-200203000-00023
发表时间：
2002-03-01
影响因子：
5.3
作者：
Bhandari, M;Guyatt, GH;Tornetta, P
通讯作者：
Tornetta, P
DOI：
10.1017/s0266462307070341
发表时间：
2007-03-01
影响因子：
3.2
作者：
Cook, Jonathan A.;Ramsay, Craig R.;Fayers, Peter
通讯作者：
Fayers, Peter