Unit of Clinical Epidemiology, Department of Anesthesiology, Geneva University Hospitals, 24 Rue Micheli-du-Crest, 1211 Geneva 14, Switzerland.
J Am Med Inform Assoc. 2009 Sep-Oct;16(5):651-9. doi: 10.1197/jamia.M3041. Epub 2009 Jun 30.
To compare users' speed, number of entry errors and satisfaction in using two current devices for electronic data collection in clinical research: handheld and laptop computers.
The authors performed a randomized cross-over trial using 160 different paper-based questionnaires and representing altogether 45,440 variables. Four data coders were instructed to record, according to a random predefined and equally balanced sequence, the content of these questionnaires either on a laptop or on a handheld computer. Instructions on the kind of device to be used were provided to data-coders in individual sealed and opaque envelopes. Study conditions were controlled and the data entry process performed in a quiet environment.
The authors compared the duration of the data recording process, the number of errors and users' satisfaction with the two devices. The authors divided errors into two separate categories, typing and missing data errors. The original paper-based questionnaire was used as a gold-standard.
The overall duration of the recording process was significantly reduced (2.0 versus 3.3 min) when data were recorded on the laptop computer (p < 0.001). Data accuracy also improved. There were 5.8 typing errors per 1,000 entries with the laptop compared to 8.4 per 1,000 with the handheld computer (p < 0.001). The difference was even more important for missing data which decreased from 22.8 to 2.9 per 1,000 entries when a laptop was used (p < 0.001). Users found the laptop easier, faster and more satisfying to use than the handheld computer.
Despite the increasing use of handheld computers for electronic data collection in clinical research, these devices should be used with caution. They double the duration of the data entry process and significantly increase the risk of typing errors and missing data. This may become a particularly crucial issue in studies where these devices are provided to patients or healthcare workers, unfamiliar with computer technologies, for self-reporting or research data collection processes.
比较两种当前用于临床研究电子数据采集的设备(手持设备和膝上型计算机)在用户使用速度、输入错误数量和满意度方面的差异。
作者采用随机交叉试验方法,使用 160 份不同的纸质问卷,共计 45440 个变量。4 名数据录入员按照随机预设且均衡的顺序,将这些问卷的内容记录在膝上型计算机或手持计算机上。使用哪种设备的说明被提供给数据录入员,并放入单独密封且不透明的信封中。研究条件受到控制,数据录入过程在安静的环境中进行。
比较两种设备的数据记录过程持续时间、错误数量和用户满意度。作者将错误分为两类,即输入错误和缺失数据错误。原始纸质问卷被用作金标准。
使用膝上型计算机记录数据时,整体记录过程的持续时间明显缩短(2.0 分钟比 3.3 分钟)(p<0.001)。数据准确性也有所提高。使用膝上型计算机时,每输入 1000 个字符会出现 5.8 个输入错误,而使用手持计算机时会出现 8.4 个输入错误(p<0.001)。对于缺失数据错误,差异更为显著,使用膝上型计算机时,每输入 1000 个字符的缺失数据错误从 22.8 个减少到 2.9 个(p<0.001)。用户发现膝上型计算机比手持计算机更易于使用、更快且更令人满意。
尽管在临床研究中越来越多地使用手持计算机进行电子数据采集,但这些设备的使用应谨慎。它们使数据录入过程的持续时间延长一倍,并显著增加输入错误和缺失数据的风险。在向不熟悉计算机技术的患者或医疗保健工作者提供这些设备进行自我报告或研究数据收集过程的研究中,这可能成为一个特别关键的问题。