The challenges faced in the design, conduct and analysis of surgical randomised controlled trials

被引:230
作者
Cook, Jonathan A. [1 ,2 ]
机构
[1] Univ Aberdeen, Hlth Serv Res Unit, Aberdeen AB25 2ZD, Scotland
[2] Ottawa Hlth Res Inst, Clin Epidemiol Program, Ottawa, ON K1Y 4E9, Canada
基金
英国医学研究理事会;
关键词
CLINICAL-TRIALS; MESH REPAIR; INGUINAL-HERNIA; LEARNING-CURVE; SURGERY; QUALITY; CONSORT; CANCER; RECRUITMENT; EXTENSION;
D O I
10.1186/1745-6215-10-9
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
引用
收藏
页数:9
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