@Article{信息:doi 10.2196 / / jmir。1120，作者=“El Emam, Khaled and Jonker, Elizabeth and Sampson, Margaret and Krle{\v{z}}a-Jeri{\'{c}}， Karmela and Neisa, Angelica”，标题=“在临床试验中使用电子数据采集工具:259个加拿大试验的网络调查”，期刊=“J Med Internet Res”，年=“2009”，月=“3”，日=“09”，卷=“11”，数=“1”，页=“e8”，关键词=“临床试验;创新的扩散;电子数据捕获;背景:电子数据捕获(EDC)工具为临床试验的数据收集、报告、查询解析、随机化和验证等功能提供自动化支持。在临床试验中有更多采用EDC工具的趋势，但在实践中有多少试验实际使用了这项技术也存在不确定性。对到2007年为止进行的EDC采用调查的系统回顾得出结论，只有20个试验正在使用EDC系统，但以前的调查存在缺陷。目的:我们的主要目标是估计2006年和2007年加拿大II/III/IV期临床试验中使用EDC系统的比例。次要目标是调查可能对采用产生影响的因素，并制定一个量表来评估EDC系统的复杂程度。方法:我们进行了一项网络调查来估计使用EDC系统的试验的比例。 The survey was sent to the Canadian site coordinators for 331 trials. We also developed and validated a scale using Guttman scaling to assess the extent of sophistication of EDC systems. Trials using EDC were compared by the level of sophistication of their systems. Results: We had a 78.2{\%} response rate (259/331) for the survey. It is estimated that 41{\%} (95{\%} CI 37.5{\%}-44{\%}) of clinical trials were using an EDC system. Trials funded by academic institutions, government, and foundations were less likely to use an EDC system compared to those sponsored by industry. Also, larger trials tended to be more likely to adopt EDC. The EDC sophistication scale had six levels and a coefficient of reproducibility of 0.901 (P< .001) and a coefficient of scalability of 0.79. There was no difference in sophistication based on the funding source, but pediatric trials were likely to use a more sophisticated EDC system. Conclusion: The adoption of EDC systems in clinical trials in Canada is higher than the literature indicated: a large proportion of clinical trials in Canada use some form of automated data capture system. To inform future adoption, research should gather stronger evidence on the costs and benefits of using different EDC systems. ", issn="1438-8871", doi="10.2196/jmir.1120", url="//www.mybigtv.com/2009/1/e8/", url="https://doi.org/10.2196/jmir.1120", url="http://www.ncbi.nlm.nih.gov/pubmed/19275984" }