Department of Anesthesiology, Amsterdam UMC, Amsterdam, The Netherlands.
Department of Intensive Care Medicine, Amsterdam UMC, Amsterdam, The Netherlands.
Crit Care Med. 2023 Sep 1;51(9):e179-e183. doi: 10.1097/CCM.0000000000005937. Epub 2023 May 18.
To study ICU trials published in the four highest-impact general medicine journals by comparing them with concurrently published non-ICU trials in the same journals.
PubMed was searched for randomized controlled trials (RCTs) published between January 2014 and October 2021 in the New England Journal of Medicine , The Lancet , the Journal of the American Medical Association , and the British Medical Journal.
Original RCT publications investigating any type of intervention in any patient population.
ICU RCTs were defined as RCTs exclusively including patients admitted to the ICU. Year and journal of publication, sample size, study design, funding source, study outcome, type of intervention, Fragility Index (FI), and Fragility Quotient were collected.
A total of 2,770 publications were screened. Of 2,431 original RCTs, 132 (5.4%) were ICU RCTs, gradually rising from 4% in 2014 to 7.5% in 2021. ICU RCTs and non-ICU RCTs included a comparable number of patients (634 vs 584, p = 0.528). Notable differences for ICU RCTs were the low occurrence of commercial funding (5% vs 36%, p < 0.001), the low number of RCTs that reached statistical significance (29% vs 65%, p < 0.001), and the low FI when they did reach significance (3 vs 12, p = 0.008).
In the last 8 years, RCTs in ICU medicine made up a meaningful, and growing, portion of RCTs published in high-impact general medicine journals. In comparison with concurrently published RCTs in non-ICU disciplines, statistical significance was rare and often hinged on the outcome events of just a few patients. Increased attention should be paid to realistic expectations of treatment effects when designing ICU RCTs to detect differences in treatment effects that are reliable and clinically relevant.
通过比较在四大最具影响力的普通医学期刊上发表的 ICU 试验与同一期刊同期发表的非 ICU 试验，研究 ICU 试验。
在 PubMed 上搜索了 2014 年 1 月至 2021 年 10 月期间在《新英格兰医学杂志》《柳叶刀》《美国医学会杂志》和《英国医学杂志》上发表的随机对照试验（RCT）。
研究任何类型干预措施在任何患者人群中的原始 RCT 出版物。
ICU RCT 定义为仅纳入 ICU 收治患者的 RCT。收集年份和期刊出版、样本量、研究设计、资金来源、研究结果、干预类型、脆弱性指数（FI）和脆弱性商数。
共筛选出 2770 篇文献。在 2431 篇原始 RCT 中，有 132 篇（5.4%）为 ICU RCT，逐渐从 2014 年的 4%上升到 2021 年的 7.5%。ICU RCT 和非 ICU RCT 纳入的患者数量相当（634 与 584，p=0.528）。值得注意的是，ICU RCT 中商业资金的低发生率（5%与 36%，p<0.001）、达到统计学意义的 RCT 数量较少（29%与 65%，p<0.001）以及达到统计学意义时的低 FI（3 与 12，p=0.008）。
在过去的 8 年中，重症监护医学的 RCT 占高影响力普通医学期刊发表的 RCT 的相当大且不断增长的部分。与同期发表的非 ICU 学科 RCT 相比，统计学意义很少见，而且往往取决于少数患者的结局事件。在设计 ICU RCT 以检测可靠和临床相关的治疗效果差异时，应更加关注对治疗效果的现实期望。
