University Division of Anesthesia and Critical Care Medicine, Department of Anesthesia, Critical Care and Perioperative Medicine, University of Brescia, Spedali Civili, Piazzale Ospedali Civili, 1, 25123, Brescia, Italy.
Intensive Care Med. 2013 Aug;39(8):1386-95. doi: 10.1007/s00134-013-2947-3. Epub 2013 Jun 7.
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.
评价 2001 年至 2010 年《重症医学》杂志上发表的随机对照试验（RCT）的方法学质量，并与我们之前对 1975 年至 2000 年发表的 RCT 的综述进行比较。
我们评估了随机分组、盲法和患者流程的报告质量，分别按照 Jadad 量表进行评估，并将其与我们之前的综述结果进行比较。对于 2001 年至 2010 年发表的 RCT，我们还评估了扭曲结果呈现（spin）和膨胀预测治疗效果（delta inflation）的频率。
在 2001 年至 2010 年的 221 项 RCT 中，样本量明显大于前一系列，且具有阴性结果的研究比例更高。关于样本量估算和分配隐藏的合理性报告显著增加，但与前一时期相比，其他重要的个体方法学组成部分的报告并没有实质性变化，仍然很低。在 2001 年至 2010 年发表的 RCT 中，有 69 项具有统计学阴性结果的 RCT 使用了 spin 策略，而在 7 项评估生存为主要结局的 RCT 中存在 delta 膨胀。Jadad 评分较高的论文比其他论文被引用的频率更高。
《重症医学》杂志上发表的 RCT 报告质量仅在一定程度上随时间有所改善，spin 和 delta 偏倚时有发生。需要更严格地遵守 CONSORT 建议，特别强调准确描述随机分组和盲法，并正确报告统计学上无显著性的结果。
