Risk of bias versus quality assessment of randomised controlled trials: cross sectional study.
Risk of bias versus quality assessment of randomised controlled trials: cross sectional study.
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DOI：
10.1136/bmj.b4012
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发表时间：
2009-10-19
期刊：
影响因子：
--
通讯作者：
Klassen TP
中科院分区：
文献类型：
--
作者：
Hartling L;Ospina M;Liang Y;Dryden DM;Hooton N;Krebs Seida J;Klassen TP
目的评价由Cochrane Collaboration引入的用于评估随机试验内部效度的偏倚风险工具（risk of bias）在评分者间一致性、与Jadad量表和Schulz分配隐瞒性方法相比的并发效度，以及偏倚风险与效应估计之间的关系。设计横断面研究。研究样本为163个儿童试验。主要结果测量使用偏倚风险工具（加权κ）评估试验的审稿人之间的评分一致性，与其他质量评估方法相比应用偏倚风险工具的时间（配对t检验），与总体质量评分相比总体风险的相关性程度（肯德尔τ统计量），以及分类为高、不明确或低偏倚风险的研究的效应估计程度（元回归）。结果在偏倚风险工具的各个域上，评分者之间的一致性从轻微（κ=0.13）到显著（κ=0.74）不等。完成偏倚风险工具的平均时间明显长于Jadad量表和Schulz方法（单独或联合使用）(每个研究v 2.0 （SD 0.8) 8.8分钟（SD 2.2）， P<0.001）。总体偏倚风险与Jadad评分（P=0.395）和Schulz方法（P=0.064）的相关性较低。高或不明确偏倚风险的研究（0.52）与低风险的研究（0.23）的效应大小不同。结论：评价者之间的一致性在偏倚风险工具的不同领域存在差异。一般来说，在那些需要更多判断力的项目上，人们的一致程度较低。总体偏倚风险评估与两种常见的质量评估方法（Jadad量表和Schulz分配隐秘性方法）之间的相关性较低。总体偏倚风险通过偏倚风险工具的差异效应估计来评估，低风险研究的偏倚风险估计更为保守。
Objectives To evaluate the risk of bias tool, introduced by the Cochrane Collaboration for assessing the internal validity of randomised trials, for inter-rater agreement, concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment, and the relation between risk of bias and effect estimates. Design Cross sectional study. Study sample 163 trials in children. Main outcome measures Inter-rater agreement between reviewers assessing trials using the risk of bias tool (weighted κ), time to apply the risk of bias tool compared with other approaches to quality assessment (paired t test), degree of correlation for overall risk compared with overall quality scores (Kendall’s τ statistic), and magnitude of effect estimates for studies classified as being at high, unclear, or low risk of bias (metaregression). Results Inter-rater agreement on individual domains of the risk of bias tool ranged from slight (κ=0.13) to substantial (κ=0.74). The mean time to complete the risk of bias tool was significantly longer than for the Jadad scale and Schulz approach, individually or combined (8.8 minutes (SD 2.2) per study v 2.0 (SD 0.8), P<0.001). There was low correlation between risk of bias overall compared with the Jadad scores (P=0.395) and Schulz approach (P=0.064). Effect sizes differed between studies assessed as being at high or unclear risk of bias (0.52) compared with those at low risk (0.23). Conclusions Inter-rater agreement varied across domains of the risk of bias tool. Generally, agreement was poorer for those items that required more judgment. There was low correlation between assessments of overall risk of bias and two common approaches to quality assessment: the Jadad scale and Schulz approach to allocation concealment. Overall risk of bias as assessed by the risk of bias tool differentiated effect estimates, with more conservative estimates for studies at low risk.
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影响因子：
4
作者：
Katrak, Persis;Bialocerkowski, Andrea E;Grimmer, Karen A
通讯作者：
Grimmer, Karen A
影响因子：
120.7
作者：
Jüni, P;Witschi, A;Egger, M
通讯作者：
Egger, M
影响因子：
168.9
作者：
Moher, D;Pham, B;Klassen, TP
通讯作者：
Klassen, TP
DOI：
10.1016/0197-2456(86)90046-2
发表时间：
1986-09-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
DERSIMONIAN, R;LAIRD, N
通讯作者：
LAIRD, N
影响因子：
105.7
作者：
Chan, AW;Altman, DG
通讯作者：
Altman, DG