Background

Critical care randomized controlled trials (RCTs) are often published in high-impact journals, whether general journals [the New England Journal of Medicine (NEJM), The Lancet, the Journal of the American Medical Association (JAMA)] or critical care journals [Intensive Care Medicine (ICM), the American Journal of Respiratory and Critical Care Medicine (AJRCCM), Critical Care Medicine (CCM)]. As rejection occurs in up to 97% of cases, it might be appropriate to assess pre-submission probability of being published. The objective of this study was to develop and internally validate a simplified score predicting whether an ongoing trial stands a chance of being published in high-impact general journals.

Methods

A cohort of critical care RCTs published between 1999 and 2018 in the three highest impact medical journals (NEJM, The Lancet, JAMA) or the three highest impact critical care journals (ICM, AJRCCM, CCM) was split into two samples (derivation cohort, validation cohort) to develop and internally validate the simplified score. Primary outcome was journal of publication assessed as high-impact general journal (NEJM, The Lancet, JAMA) or critical care journal (ICM, AJRCCM, CCM).

Results

A total of 968 critical care RCTs were included in the predictive cohort and split into a derivation cohort (n = 510) and a validation cohort (n = 458). In the derivation cohort, the sample size (P value < 0.001), the number of centers involved (P value = 0.01), mortality as primary outcome (P value = 0.002) or a composite item including mortality as primary outcome (P value = 0.004), and topic [ventilation (P value < 0.001) or miscellaneous (P value < 0.001)] were independent factors predictive of publication in high-impact general journals, compared to high-impact critical care journals. The SCOTI score (Sample size, Centers, Outcome, Topic, and International score) was developed with an area under the ROC curve of 0.84 (95% Confidence Interval, 0.80–0.88) in validation by split sample.

Conclusions

The SCOTI score, developed and validated by split sample, accurately predicts the chances of a critical care RCT being published in high-impact general journals, compared to high-impact critical care journals.

中文翻译：

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在影响因子最高的期刊上成功发表重症监护医学随机对照试验的多变量模型：SCOTI 评分

背景

重症监护随机对照试验 (RCT) 通常发表在高影响力期刊上，无论是普通期刊 [新英格兰医学杂志 (NEJM)、柳叶刀、美国医学会杂志 (JAMA)] 还是重症监护期刊 [重症监护医学 (ICM)、美国呼吸与重症监护医学杂志 (AJRCCM)、重症监护医学 (CCM)]。由于高达 97% 的情况会发生拒绝，因此评估提交前发布的可能性可能是合适的。这项研究的目的是开发和内部验证一个简化的分数，预测正在进行的试验是否有机会在高影响力的普通期刊上发表。

方法

将 1999 年至 2018 年在三个最具影响力的医学期刊（NEJM、柳叶刀、JAMA）或三个最有影响力的重症监护期刊（ICM、AJRCCM、CCM）上发表的重症监护 RCT 队列分为两个样本（推导队列、验证队列）来开发和内部验证简化的分数。主要结果是被评估为高影响力普通期刊（NEJM、柳叶刀、JAMA）或重症监护期刊（ICM、AJRCCM、CCM）的期刊。

结果

共有 968 项重症监护 RCT 被纳入预测队列，并分为推导队列 ( n  = 510) 和验证队列 ( n  = 458)。在推导队列中，样本量（P值 < 0.001）、所涉及的中心数量（P值 = 0.01）、死亡率作为主要结果（P值 = 0.002）或包括死亡率作为主要结果的复合项目（P值 = 0.004) 和主题 [通风 ( P值 < 0.001) 或杂项 ( P值 < 0.001)] 是预测在高影响力普通期刊上发表的独立因素，与高影响力重症监护期刊相比。SCOTI 评分（样本大小、中心、结果、主题和国际评分）的 ROC 曲线下面积为 0.84（95% 置信区间，0.80-0.88），以通过拆分样本进行验证。

结论

与高影响力重症监护期刊相比，通过拆分样本开发和验证的 SCOTI 评分准确预测了重症监护 RCT 在高影响力普通期刊上发表的机会。