Diener-West M, Connor P B, Newhouse M M, Hawkins B S
School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Control Clin Trials. 1998 Feb;19(1):39-49. doi: 10.1016/s0197-2456(97)00094-9.
As part of an ongoing clinical trial, we conducted an experiment to assess the feasibility and to determine the reliability of data entry from a computer screen display of images of data collection forms transmitted by facsimile (fax) machines directly into a computer for paper forms designed without consideration of fax or image display requirements. Feasibility was assessed on the basis of accuracy and reliability of data entry and on operator satisfaction. During a 2-week period, half of the forms received at the Collaborative Ocular Melanoma Study (COMS) coordinating center were key-entered twice, using the paper forms as the source (paper source entry). The remaining forms were entered once using paper source and were later reentered using the screen display of images of the faxed forms as the source (image source entry). The latter group of forms, or 50% of all forms received, were entered a third time, using the image source entry. Two data entry operators participated in the experiment. Discrepancy rates between and within data entry operators were calculated for both modes of entry. A total of 50,861 keystrokes (28,095 items) across 1122 records were checked for consistency. The overall discrepancy rate associated with double paper source entry was approximately 21 per 10,000 keystrokes (20 per 10,000 items). Discrepancy rates associated with paper source versus image source entry (53 per 10,000 keystrokes [57 per 10,000 items]) and double image source entry (57 per 10,000 keystrokes [47 per 10,000 items]) were similar in magnitude. Image source entry of forms received by facsimile may provide an acceptable alternative to paper entry in ongoing multicenter clinical trials where the costs of converting existing forms and systems to automated data capture may be unacceptable. This experiment confirmed the feasibility of such an alternative and suggested that improved screen displays and changes in equipment to facilitate entry of data from the screen display may enhance accuracy of entries.
作为一项正在进行的临床试验的一部分，我们开展了一项实验，以评估将传真机传输的数据收集表图像的电脑屏幕显示直接录入计算机（该纸质表格设计时未考虑传真或图像显示要求）的可行性，并确定数据录入的可靠性。可行性根据数据录入的准确性和可靠性以及操作员满意度进行评估。在为期两周的时间里，协作性眼黑色素瘤研究（COMS）协调中心收到的一半表格被使用纸质表格作为来源进行了两次键录入（纸质来源录入）。其余表格使用纸质来源录入一次，之后使用传真表格图像的屏幕显示作为来源再次录入（图像来源录入）。后一组表格，即所有收到表格的50%，使用图像来源录入进行了第三次录入。两名数据录入操作员参与了该实验。计算了两种录入模式下数据录入操作员之间以及操作员内部的差异率。对1122条记录中的总共50,861次击键（28,095项）进行了一致性检查。与双重纸质来源录入相关的总体差异率约为每10,000次击键21次（每10,000项20次）。与纸质来源录入和图像来源录入相关的差异率（每10,000次击键53次[每10,000项57次]）以及双重图像来源录入的差异率（每10,000次击键57次[每10,000项47次]）在数量上相似。在正在进行的多中心临床试验中，对于将现有表格和系统转换为自动数据采集的成本可能无法接受的情况，传真接收表格的图像来源录入可能为纸质录入提供一种可接受的替代方法。该实验证实了这种替代方法的可行性，并表明改进屏幕显示以及改变设备以方便从屏幕显示录入数据可能会提高录入的准确性。
