Intensive Care Unit, Caboolture Hospital, Caboolture, QLD, Australia.
Adult Intensive Care Services, The Prince Charles Hospital, Chermside, QLD, Australia.
Clin Trials. 2022 Dec;19(6):673-680. doi: 10.1177/17407745221123248. Epub 2022 Sep 6.
BACKGROUND/AIMS: To summarise the temporal trends of recruitment and methodological characteristics of critical care randomised controlled trials with the primary outcome of mortality.
PubMed was searched for articles meeting inclusion and exclusion criteria. Randomised controlled trials, with primary outcome of mortality, of adult and paediatric critical care patients treated in an intensive care unit, were included. Neonatal intensive care unit trials, non-English publications and conference proceedings or abstracts without full-length publications were excluded. Duplicate literature search, article selection and quality assessment were performed by two reviewers with disputes resolved through discussion. Data were extracted into a custom-designed Research Electronic Data Capture database.
The search identified 67,199 records of which 230 were included. The annual number of critical care randomised controlled trials published increased gradually over a 30-year period from 0 in 1990 to 19 in 2014 with stabilisation at 8-11 between 2015 and 2020. Twenty-seven percent of randomised controlled trials were low risk in all categories using the Cochrane Risk of Bias tool. Methodological characteristics such as registration on clinical trials registries and data safety monitoring committee presence significantly (p < 0.001) increased over time. The median recruitment was 376 patients (interquartile range 125-895) with significant increase (p = 0.002) from 62 (interquartile range: 33-486) in 1991 to 725 (interquartile range: 537-2600) in 2020. This was accompanied by an increase in recruitment times. Thus overall, recruitment rates did not increase. Early cessation occurred in 23% (54/230) of randomised controlled trials with no temporal trend.
The number, size and some methodological qualities of critical randomised controlled trials with primary outcome of mortality have increased over time, but rates of recruitment and early cessation have been unchanged.
背景/目的：总结以死亡率为主要结局的重症监护随机对照试验的招募时间趋势和方法学特征。
在 PubMed 上搜索符合纳入和排除标准的文章。纳入成年和儿科重症监护患者在重症监护病房接受治疗的随机对照试验，主要结局为死亡率。排除新生儿重症监护病房试验、非英语出版物以及没有全文出版物的会议记录或摘要。通过两名审查员进行重复文献搜索、文章选择和质量评估，通过讨论解决争议。将数据提取到定制的研究电子数据捕获数据库中。
搜索共确定了 67199 条记录，其中 230 条被纳入。在 30 年的时间里，以死亡率为主要结局的重症监护随机对照试验的发表数量逐渐增加，从 1990 年的 0 篇增加到 2014 年的 19 篇，在 2015 年至 2020 年期间稳定在 8-11 篇。使用 Cochrane 偏倚风险工具，27%的随机对照试验在所有类别中均为低风险。注册临床试验注册机构和数据安全监测委员会的存在等方法学特征随着时间的推移显著增加（p < 0.001）。中位入组人数为 376 例（四分位距 125-895），从 1991 年的 62 例（四分位距 33-486）显著增加（p = 0.002）至 2020 年的 725 例（四分位距 537-2600）。这伴随着入组时间的增加。因此，总体而言，入组率并未增加。23%（54/230）的随机对照试验提前终止，且无时间趋势。
以死亡率为主要结局的重症随机对照试验的数量、规模和一些方法学质量随着时间的推移有所增加，但招募率和提前终止率保持不变。
