Takaoka Alyson, Johnstone Jennie, Lauzier François, Heels-Ansdell Diane, Davis Megan, Zytaruk Nicole, Duan Erick, Dionne Joanna, Saunders Lois, Arabi Yaseen M, Marshall John, Thabane Lehana, Clarke France, Hand Lori, Masse Marie-Helene, Rochwerg Bram, McIntyre Lauralyn, Girard Martin, Freitag Andreas, Karachi Tim, Cook Deborah J
Queen's University, Kingston, Canada.
University of Toronto, Toronto, Canada.
Trials. 2024 Dec 27;25(1):851. doi: 10.1186/s13063-024-08701-w.
Understanding site-related factors that influence enrolment within multicenter randomized controlled trials (RCT) may help reduce trial delays and cost over-runs and prevent early trial discontinuation. In this analysis of PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial), we describe patient enrolment patterns and examine factors influencing site-based monthly enrolment.
Retrospective analysis of a multicenter RCT.
The PROSPECT multicenter RCT enrolled patients in the main trial from July 2015 to March 2019. We documented site characteristics and trial metrics including data from the methods center tracking documents, site-level data at trial initiation, screening logs submitted by research coordinators, and prospectively collected case report forms. In this retrospective analysis of trial data, we analyzed enrolment patterns across sites using negative binomial regression to explore the association between monthly enrolment rate accounting for number of ICU beds, site characteristics, and trial metrics.
Overall, 41 sites enrolling 2365 patients in the PROSPECT main trial were analyzed. After accounting for number of beds in each ICU, site launch early in the trial was associated with higher monthly enrolment rates, but time to first enrolment and research coordinator experience was not. We observed considerable variability in the number of active screening months and enrolment rates across sites.
These findings highlight the complexity of recruitment dynamics in critical care RCTs and emphasize the need for tailored approaches to trial planning and execution.
PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial): NCT02462590 (registered June 2, 2015).
了解影响多中心随机对照试验（RCT）入组的与试验点相关的因素，可能有助于减少试验延迟和成本超支，并防止试验提前终止。在对PROSPECT（益生菌：预防严重肺炎和气管内定植试验）的这项分析中，我们描述了患者入组模式，并研究了影响各试验点每月入组的因素。
对一项多中心RCT进行回顾性分析。
PROSPECT多中心RCT在2015年7月至2019年3月期间纳入主要试验的患者。我们记录了试验点特征和试验指标，包括来自方法中心跟踪文件的数据、试验启动时的试验点层面数据、研究协调员提交的筛查日志，以及前瞻性收集的病例报告表。在对试验数据的这项回顾性分析中，我们使用负二项回归分析各试验点的入组模式，以探讨考虑重症监护病房床位数量、试验点特征和试验指标后的每月入组率之间的关联。
总体而言，分析了在PROSPECT主要试验中纳入2365例患者的41个试验点。在考虑每个重症监护病房的床位数后，试验早期启动的试验点每月入组率较高，但首次入组时间和研究协调员经验并非如此。我们观察到各试验点在活跃筛查月数和入组率方面存在很大差异。
这些发现突出了重症监护RCT中招募动态的复杂性，并强调了针对试验规划和实施采取定制方法的必要性。
PROSPECT（益生菌：预防严重肺炎和气管内定植试验）：NCT02462590（于2015年6月2日注册）。
