Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle-Ottawa Scale and the RTI item bank.
Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle-Ottawa Scale and the RTI item bank.
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DOI：
10.2147/clep.s66677
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发表时间：
2014
影响因子：
3.9
通讯作者：
Perez-Gutthann S
中科院分区：
文献类型：
--
作者：
Margulis AV;Pladevall M;Riera-Guardia N;Varas-Lorenzo C;Hazell L;Berkman ND;Viswanathan M;Perez-Gutthann S
本研究的目的是比较Newcastle-Ottawa量表（NOS）和RTI项目库（RTI-IB），并在降糖药物心血管安全性的系统评价中使用RTI-IB估计评价者间一致性。我们对这两种工具进行了定制，并在RTI-IB中添加了四个问题。两名评审员评估了44项使用两种工具的纳入研究的质量（独立于RTI-IB），并就哪些回答传达了低、不明确或高偏倚风险达成一致。对于RTI-IB中的每个问题（n=31），观察到的评价者间一致性计算为两位评价者给出相同偏倚评估的研究的百分比;使用一阶一致性系数（AC 1）统计量估计经机会调整的评价者间一致性。NOS比RTI-IB需要更少的定制，更容易使用，但RTI-IB产生了更全面的评估。RTI-IB包括NOS中测量的大部分结构域。观察到的RTI-IB的中位评估者间一致性为75%（第25百分位数[p25] =61%; p75 =89%）;中位AC 1统计量为0.64（p25 =0.51; p75 =0.86）。RTI-IB有助于比NOS更全面的质量评估，但负担更重。本研究中观察到的一致性和AC 1统计量高于RTI-IB开发人员报告的一致性和AC 1统计量。
The study objective was to compare the Newcastle–Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs. We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic. The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86). The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB’s developers.