Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
J Crit Care. 2013 Feb;28(1):28-39. doi: 10.1016/j.jcrc.2012.08.005. Epub 2012 Oct 22.
Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials.
The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143).
Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily.
The trial was conducted in 67 centers in 6 countries.
A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with >10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001).
Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.
成功完成随机试验取决于高效且符合伦理地筛选患者并获得知情同意。了解获得同意的可改变障碍可能会为正在进行和未来的试验提供信息。
本研究旨在描述并检查国际肝素血栓预防试验（重症监护血栓预防试验，clinicaltrials.gov NCT00182143）中同意率的决定因素。
在整个 4 年试验期间，研究人员向符合条件的重症患者或其替代决策者征求知情同意。每天记录是否获得或拒绝同意。
试验在 6 个国家的 67 个中心进行。
共随机分配了 3764 名患者。在参与的中心中，总体同意率为 82.2%（范围为 50%-100%）。替代决策制定者和患者分别同意了 90.1%和 9.9%的案例。有五个因素与同意率独立相关。经验更丰富的研究协调员获得更高的同意率（优势比[OR]，3.43；95%置信区间，2.42-4.86；对于那些具有>10 年经验的人，P<.001）。与 15 至 20 张床、21 至 25 张床和大于 25 张床的 ICU 相比，床位数小于 15 张的 ICU 的同意率更高（所有 OR 均<0.5；P<.001），并且全职研究人员多于 1 名的中心的同意率更高（OR，1.95；95%置信区间，1.28-2.99；P<.001）。与其他中心相比，隶属于加拿大重症监护试验组或澳大利亚和新西兰重症监护协会临床试验组的中心的同意率较低（OR，0.57；95%置信区间，0.42-0.77；P<.001）。最后，在试点试验期间同意率最高，在全面试验开始时最低，并且在招募的多年内增加（P<.001）。
研究中心、研究基础设施和经验的特点是与成功获得参加这项血栓预防试验的知情同意相关的重要因素。
