电子数据采集工具在临床试验中的应用Web-Survey of 259 Canadian Trials %A El Emam,Khaled %A Jonker,Elizabeth %A Sampson,Margaret %A Krleža-Jerić，Karmela %A Neisa,Angelica %+ CHEO Research Institute, 401 Smyth Road, Ottawa, ON K1H 8L1, Canada， +1 613 738 4181, kelemam@uottawa.ca %K临床试验%K创新扩散%K电子数据捕获%K数据收集%D 2009 %7 09.3.2009 %9 Original Paper %J J Med Internet Res %G English %X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。在临床试验中越来越多地采用EDC工具是一种趋势，但也不确定有多少试验在实践中实际使用了这项技术。对2007年之前进行的EDC采用调查的系统回顾得出结论，只有20%的试验使用了EDC系统，但之前的调查存在弱点。目的:我们的主要目的是估计2006年和2007年使用EDC系统的加拿大II/III/IV期临床试验的比例。第二个目标是调查可能影响采用的因素，并制定一个规模来评估EDC系统的复杂程度。方法:我们进行了一项网络调查，以估计使用EDC系统的试验比例。调查结果被发送给加拿大现场协调员进行331次试验。我们还开发并验证了一个使用Guttman尺度来评估EDC系统复杂程度的尺度。 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. %M 19275984 %R 10.2196/jmir.1120 %U //www.mybigtv.com/2009/1/e8/ %U https://doi.org/10.2196/jmir.1120 %U http://www.ncbi.nlm.nih.gov/pubmed/19275984