Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.

Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.
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DOI:
10.1016/j.cct.2010.03.005
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发表时间:
2010-05
影响因子:
2.2
通讯作者:
Dahman B
Dahman B
中科院分区:
医学4区
文献类型:
--
作者:
Penberthy L;Brown R;Puma F;Dahman B

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临床试验(CT)是将临床研究转化为护理标准的媒介。招募人数少或缓慢导致向公众提供新疗法的延误。确定所有患者的合格性是确保临床试验过程中无偏倚结果的最重要因素之一,也是解决临床试验代表性不足和平等获得临床试验机会问题的第一步。这是一个试点项目,旨在评估自动化临床试验合格性筛选工具在5种不同临床试验和临床试验场景中的效率、灵活性和通用性。在研究期间,研究人员用于评估患者合格性的时间从165小时到1,329小时不等,节省了大量的总时间。除了一项试验研究外,自动化系统的效率都有显著提高。人工与自动化过程中,每例合格患者所需的平均工作人员时间比范围为0.8 - 19.4。本研究的结果表明,自动化提供了一个机会,以减少CT资格筛选所需的手动过程的负担,并确保所有患者都有机会在适当的情况下接受临床试验参与评估。与传统的手工程序相比,自动程序将资格评估程序的工作量有效地转移到计算机上,大大减少了资格筛选所花费的时间。
Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios. There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165 hours to 1,329 hours. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process. The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces that time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer.
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