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在一项针对临床研究专业人员的研究中,观察到培训协议的遵守率为 13%。

A training protocol compliance of 13% was observed in a research study of clinical research professionals.

机构信息

Bioethics Research Center, Washington University School of Medicine, St. Louis, MO, USA.

School of Global Public Health, New York University, New York, NY, USA.

出版信息

BMC Res Notes. 2024 Aug 1;17(1):214. doi: 10.1186/s13104-024-06870-0.

Abstract

OBJECTIVE

We attempted to conduct a randomized controlled trial of three different informed consent training formats to evaluate their effectiveness. We recruited 503 clinical research professionals, who received $50 for participation. Incidental findings showed unexpectedly low rates of compliance with completing the study training protocols, resulting in insufficient statistical power to test our original hypotheses. In this report, we conducted a secondary analysis of the data in which we characterize and evaluate the observed low compliance. This involved using literature on average reading times, speed-reading times, and video play speeds to calculate the timeframes required to complete the three training formats.

RESULTS

Only 13% of participants completed the training in a reasonable timeframe. Furthermore, only 46% of participants completed the training in the minimum possible timeframe. These findings lead us to ask whether online research training is effective, since no training can be effective if participants do not actually complete the training. Given extensive requirements for educational training among clinical research professionals, we feel the burden of proof is on training programs to demonstrate that they have positive effects.

摘要

目的

我们尝试进行了一项随机对照试验,比较三种不同的知情同意书培训模式,以评估其效果。我们招募了 503 名临床研究专业人员,每位参与者可获得 50 美元的报酬。偶然发现的结果显示,参与者完成研究培训方案的依从率出乎意料地低,导致我们最初的假设无法进行充分的统计检验。在本报告中,我们对数据进行了二次分析,旨在对观察到的低依从率进行描述和评估。我们使用文献中关于平均阅读时间、快速阅读时间和视频播放速度的数据,计算完成三种培训模式所需的时间框架。

结果

只有 13%的参与者在合理的时间框架内完成了培训。此外,只有 46%的参与者在最短可能的时间内完成了培训。这些发现使我们不禁要问,在线研究培训是否有效,因为如果参与者实际上没有完成培训,那么任何培训都不可能有效。鉴于临床研究专业人员对教育培训有广泛的要求,我们认为培训计划有责任证明其具有积极影响。

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