Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data.
Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data.
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DOI：
10.1371/journal.pone.0025348
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Jeffries D
中科院分区：
文献类型：
--
作者：
Walther B;Hossin S;Townend J;Abernethy N;Parker D;Jeffries D
传统上，临床研究依靠病例报告表收集数据，随后将其输入数据库以创建电子记录。虽然这种方法已经很好地建立起来，但它既耗时又容易出错。本研究比较了四种电子数据采集（EDC）方法与传统方法的数据采集时间和准确性。它是在西非环境中进行的，临床试验涉及从城市，农村和偏远地区收集数据。在面对面访谈中评估了三种常用的EDC工具：上网本、PDA和平板电脑。通过移动的电话进行电话访谈期间的EDC性能作为第四种方法进行评价。Graeco拉丁方研究设计允许将所有四种方法与标准纸质记录进行比较，然后进行数据双录入，同时控制可能的混杂因素，如访谈顺序，访谈者和受访者。在为期三周的研究期间，所有EDC方法的错误率都大大降低。在研究的最后一周，（5.1%，CI 95%：3.5-7.2%）和平板电脑（5.2%，CI 95%：3.7-7.4%）与传统纸基方法的准确性无显著差异（3.6%，CI 95%：2.2-5.5%），但PDA（7.9%，CI 95%：6.0-10.5%）和电话（6.3%，CI 95%：4.6-8.6%）的错误率仍显著较高。虽然EDC访谈需要稍长的时间，但数据在下载后即可获得，使EDC更具时效性。自由文本和日期字段的错误率高于数字、单选和跳过字段。与纸质方法相比，EDC解决方案有可能产生类似的数据准确性。鉴于从数据收集到数据库锁定的时间大大缩短，EDC有望降低研究相关成本。不过，成功推行电子产品分类，需要调整工作程序和重新分配资源。
Traditionally, clinical research studies rely on collecting data with case report forms, which are subsequently entered into a database to create electronic records. Although well established, this method is time-consuming and error-prone. This study compares four electronic data capture (EDC) methods with the conventional approach with respect to duration of data capture and accuracy. It was performed in a West African setting, where clinical trials involve data collection from urban, rural and often remote locations. Three types of commonly available EDC tools were assessed in face-to-face interviews; netbook, PDA, and tablet PC. EDC performance during telephone interviews via mobile phone was evaluated as a fourth method. The Graeco Latin square study design allowed comparison of all four methods to standard paper-based recording followed by data double entry while controlling simultaneously for possible confounding factors such as interview order, interviewer and interviewee. Over a study period of three weeks the error rates decreased considerably for all EDC methods. In the last week of the study the data accuracy for the netbook (5.1%, CI95%: 3.5–7.2%) and the tablet PC (5.2%, CI95%: 3.7–7.4%) was not significantly different from the accuracy of the conventional paper-based method (3.6%, CI95%: 2.2–5.5%), but error rates for the PDA (7.9%, CI95%: 6.0–10.5%) and telephone (6.3%, CI95% 4.6–8.6%) remained significantly higher. While EDC-interviews take slightly longer, data become readily available after download, making EDC more time effective. Free text and date fields were associated with higher error rates than numerical, single select and skip fields. EDC solutions have the potential to produce similar data accuracy compared to paper-based methods. Given the considerable reduction in the time from data collection to database lock, EDC holds the promise to reduce research-associated costs. However, the successful implementation of EDC requires adjustment of work processes and reallocation of resources.
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影响因子：
4.1
作者：
SALTHOUSE, TA
通讯作者：
SALTHOUSE, TA
影响因子：
2.5
作者：
Shelby-James, Tania M.;Abernethy, Amy P.;Currow, David C.
通讯作者：
Currow, David C.
谁在使用 PDA？医疗保健提供者使用 PDA 的估计：调查的系统回顾。
影响因子：
7.4
作者：
Garritty C;El Emam K
通讯作者：
El Emam K
DOI：
10.1016/j.ijmedinf.2008.10.006
发表时间：
2009-11-01
影响因子：
4.9
作者：
Seebregts, Christopher J.;Zwarenstein, Merrick;Klepp, Knut-Inge
通讯作者：
Klepp, Knut-Inge
DOI：
10.4269/ajtmh.2007.77.393
发表时间：
2007-08-01
影响因子：
3.3
作者：
Eng, Jodi L. Vanden;Wolkon, Adam;Hightower, Allen W.
通讯作者：
Hightower, Allen W.