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一项关于用于临床研究注册数据采集的电子源的比较有效性研究。

A comparative effectiveness study of eSource used for data capture for a clinical research registry.

作者信息

Nordo Amy Harris, Eisenstein Eric L, Hawley Jeffrey, Vadakkeveedu Sai, Pressley Melissa, Pennock Jennifer, Sanderson Iain

机构信息

Duke University School of Medicine- Office of Research Informatics, 2424 Erwin Road, Durham, NC 27701, USA.

Duke University Clinical Research Institute, 2400 Pratt Street, Terrace Level 0311, Durham, NC 27705, USA.

出版信息

Int J Med Inform. 2017 Jul;103:89-94. doi: 10.1016/j.ijmedinf.2017.04.015. Epub 2017 Apr 29.

Abstract

OBJECTIVE

This pilot study compared eSource-enabled versus traditional manual data transcription (non-eSource methods) for the collection of clinical registry information. The primary study objective was to compare the time spent completing registry forms using eSource versus non-eSource methods The secondary objectives were to compare data quality associated with these two data capture methods and the flexibility of the workflows. This study directly addressed fundamental questions relating to eSource adoption: what time-savings can be realized, and to what extent does eSource improve data quality.

MATERIALS AND METHODS

The study used time and motion methods to compare eSource versus non-eSource data capture workflows for a single center OB/GYN registry. Direct observation by industrial engineers using specialized computer software captured keystrokes, mouse clicks and video recordings of the study team in their normal work environment completing real-time data collection.

RESULTS

The overall average data capture time was reduced with eSource versus non-eSource methods (difference, 151s per case; eSource, 1603s; non-eSource, 1754s; p=0.051). The average data capture time for the demographic data was reduced (difference, 79s per case; eSource, 133s; non-eSource, 213s; p<0.001). This represents a 37% time reduction (95% confidence interval 27% to 47%). eSourced data field transcription errors were also reduced (eSource, 0%; non-eSource, 9%).

CONCLUSION

The use of eSource versus traditional data transcription was associated with a significant reduction in data entry time and data quality errors. Further studies in other settings are needed to validate these results.

摘要

目的

本试点研究比较了使用电子源数据采集与传统手动数据转录(非电子源方法)来收集临床登记信息的情况。主要研究目的是比较使用电子源方法与非电子源方法完成登记表格所花费的时间。次要目的是比较这两种数据采集方法相关的数据质量以及工作流程的灵活性。本研究直接解决了与采用电子源数据采集相关的基本问题:能实现哪些时间节省,以及电子源数据采集在多大程度上提高了数据质量。

材料与方法

该研究采用时间与动作研究方法,比较了单一中心妇产科登记处的电子源数据采集与非电子源数据采集工作流程。工业工程师在正常工作环境中,使用专门的计算机软件直接观察研究团队完成实时数据收集时的击键、鼠标点击操作以及视频记录。

结果

与非电子源方法相比,使用电子源方法时总体平均数据采集时间有所减少(差异为每例151秒;电子源方法为1603秒,非电子源方法为1754秒;p = 0.051)。人口统计学数据的平均数据采集时间减少(差异为每例79秒;电子源方法为133秒,非电子源方法为213秒;p < 0.001)。这代表时间减少了37%(95%置信区间为27%至47%)。电子源数据字段转录错误也有所减少(电子源方法为0%,非电子源方法为9%)。

结论

与传统数据转录相比,使用电子源数据采集可显著减少数据录入时间和数据质量错误。需要在其他环境中进行进一步研究以验证这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c14/5942198/467ef71a4e7a/nihms959080f1.jpg

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