Clustering in surgical trials--database of intracluster correlations.
Clustering in surgical trials--database of intracluster correlations.
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DOI：
10.1186/1745-6215-13-2
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发表时间：
2012-01-04
期刊：
影响因子：
2.5
通讯作者：
Seiler CM
中科院分区：
文献类型：
--
作者：
Cook JA;Bruckner T;MacLennan GS;Seiler CM
外科干预措施的随机试验评估经常被设计和分析，就好像个别患者的结果独立于提供干预的外科医生一样。由于先前的经验、个人实践、培训和基础设施，有理由预计由同一外科医生治疗的患者的结果往往比由另一名外科医生护理的患者更相似。这种现象被称为集群效应，并可能对所采用的设计和分析产生影响，从而影响所需的样本量。这项工作的目的是通过使用外科试验数据库量化不同结果的聚集效应(在中心和外科医生水平)，从而为试验设计提供信息。对中心和外科医生水平的一系列结果和不同时间点的10个多中心外科试验的结果计算了簇内相关系数(ICCs)。在中心和外科医生群级别的10个试验中计算了198个结果的ICCS。在整个审判过程中，案件数量从138起到1370起不等。中心和外科医生级别的中位数(范围)平均群集大小分别为32(9到51)和6(3到30)。ICC估计在不同的结果类型之间有很大差异，尽管围绕单个ICC估计的不确定性很大，这反映在一般较宽的可信区间。这个外科试验数据库为试验人员提供了如何设计外科试验的有价值的信息。我们的数据表明，结果的集群化比之前承认的问题更严重。我们预计，随着时间的推移，将进一步外科试验数据集中的ICC添加到我们的数据库中将进一步为外科试验的设计提供信息。
Randomised trials evaluation of surgical interventions are often designed and analysed as if the outcome of individual patients is independent of the surgeon providing the intervention. There is reason to expect outcomes for patients treated by the same surgeon tend to be more similar than those under the care of another surgeon due to previous experience, individual practice, training, and infrastructure. Such a phenomenon is referred to as the clustering effect and potentially impacts on the design and analysis adopted and thereby the required sample size. The aim of this work was to inform trial design by quantifying clustering effects (at both centre and surgeon level) for various outcomes using a database of surgical trials. Intracluster correlation coefficients (ICCs) were calculated for outcomes from a set of 10 multicentre surgical trials for a range of outcomes and different time points for clustering at both the centre and surgeon level. ICCs were calculated for 198 outcomes across the 10 trials at both centre and surgeon cluster levels. The number of cases varied from 138 to 1370 across the trials. The median (range) average cluster size was 32 (9 to 51) and 6 (3 to 30) for centre and surgeon levels respectively. ICC estimates varied substantially between outcome type though uncertainty around individual ICC estimates was substantial, which was reflected in generally wide confidence intervals. This database of surgical trials provides trialists with valuable information on how to design surgical trials. Our data suggests clustering of outcome is more of an issue than has been previously acknowledged. We anticipate that over time the addition of ICCs from further surgical trial datasets to our database will further inform the design of surgical 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：
105.7
作者：
Campbell, MK;Elbourne, DR;Altman, DG
通讯作者：
Altman, DG
影响因子：
9
作者：
Seiler, Christoph M.;Bruckner, Thomas;Knaebel, Hanns-Peter
通讯作者：
Knaebel, Hanns-Peter
影响因子：
2
作者：
Ukoumunne, OC
通讯作者：
Ukoumunne, OC
影响因子：
2
作者：
Walter, S. D.;Ismaila, A. S.;Devereaux, P. J.
通讯作者：
Devereaux, P. J.