Quality of reporting of randomized controlled trials published in Intensive Care Medicine from 2001 to 2010
Quality of reporting of randomized controlled trials published in Intensive Care Medicine from 2001 to 2010
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DOI：
10.1007/s00134-013-2947-3
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发表时间：
2013-08-01
影响因子：
38.9
通讯作者：
Minelli, Cosetta
中科院分区：
文献类型：
--
作者：
Latronico, Nicola;Metelli, Marta;Minelli, Cosetta
评价2001年至2010年发表在《重症监护医学》杂志上的随机对照试验(RCT)的方法学质量，并与1975年至2000年发表的RCT回顾进行比较。我们评估了Jadad量表中关于随机、盲法和参与者流动的报道的质量，并将其与我们先前综述的结果进行了比较。对于2001年至2010年发表的随机对照试验，我们还评估了扭曲的发现陈述(SPIN)和夸大的预测治疗效果(增量膨胀)的频率。在2001至2010年的221篇随机对照试验中，样本量明显大于较早的系列，研究结果为阴性的比例更高。对估计样本量和隐藏分配的理由的报告大大增加，但对其他重要的个别方法组成部分的报告与上一期间相比没有实质性变化，仍然较低。在2001-2010年间的随机对照试验中，111个随机对照试验中有69个采用了旋转策略，其结果在统计学上为阴性，而在11个随机对照试验中，有7个在评估存活率作为主要结果时出现了增量膨胀。Jadad评分较高的论文被引用的频率较高。《重症监护医学》上发表的随机对照试验的报道质量随着时间的推移只有部分改善，旋转和增量偏差经常发生。需要更加严格地遵守CONTORT的建议，特别强调对随机化和盲目性的准确描述，以及对统计上不显著的结果的正确报告。
To evaluate the methodological quality of randomized controlled trials (RCTs) published in Intensive Care Medicine from 2001 to 2010, and to compare it with a previous review of RCTs published from 1975 to 2000.We assessed the quality of reporting of randomization, blinding and participant flow, both individually and combined within the Jadad scale, and compared them with findings from our previous review. For RCTs published from 2001 to 2010, we also evaluated the frequency of distorted finding presentation (spin) and inflated predicted treatment effect (delta inflation).In the 221 RCTs from 2001 to 2010, the sample size was significantly larger than in the older series, and there was a higher proportion of studies with negative findings. Reporting of the rationale for sample size estimation and allocation concealment increased significantly, but reporting of other important individual methodological components did not change substantially compared with the previous period and remained low. Among RCTs from 2001 to 2010, a spin strategy was used in 69 of 111 RCTs with statistically negative results, while delta inflation was present in 7 of 11 RCTs evaluating survival as a primary outcome. Papers with higher Jadad scores were cited more often than the others.Quality of reporting of RCTs published in Intensive Care Medicine has only partly improved over time, and spin and delta bias are of frequent occurrence. There is a need for stronger adherence to CONSORT recommendations, with special emphasis on accurate description of randomization and blindness, and correct reporting of statistically non-significant results.