Rivera Morris L, Donnelly Jason, Parry Blair A, Dinizio Anthony, Johnson Charles L, Kline Jeffrey A, Kabrhel Christopher
Dept. of Emergency Medicine, Hilo Medical Center, Hilo, HI, USA.
BMC Med Inform Decis Mak. 2008 Jan 18;8:3. doi: 10.1186/1472-6947-8-3.
Personal digital assistants (PDA) offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated.
We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper) onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively.
We enrolled 68 patients (37 PDA, 31 paper). Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient) compared to paper (9:12 min per patient; p < 0.001). There were a total of 0.9 missing and nonsense errors per paper form compared to 0.2 errors per PDA form (p < 0.001). An additional 0.7 errors per paper form were generated during transcription. In total, there were 1.6 errors per paper form and 0.2 errors per PDA form (p < 0.001).
Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.
个人数字助理(PDA)在收集研究数据方面比纸质记录具有公认的优势。然而,在急诊科中,尚无前瞻性比较PDA与纸质记录的相关数据。本研究的目的是前瞻性比较PDA和纸质登记工具在所需时间和产生的错误方面的表现。
我们将正在进行的前瞻性研究中连续纳入的患者随机分组,使其数据分别记录在PDA或纸质数据收集工具上。对于每种方法,我们记录登记所需的总时间,以及手动转录(纸质)到计算机数据库所需的时间。我们通过检查缺失数据、无意义数据以及纸质表格转录过程中出现的错误来比较数据错误率。分别采用Kruskal-Wallis检验和泊松回归分析对时间和错误进行统计学比较。
我们纳入了68例患者(37例使用PDA,31例使用纸质记录)。31份纸质表格中有2份无法用于分析。与纸质记录(每位患者9:12分钟)相比,PDA记录(每位患者6:13分钟)的总数据收集时间(包括转录时间)显著缩短(p < 0.001)。每份纸质表格共有0.9个缺失和无意义错误,而每份PDA表格有0.2个错误(p < 0.001)。在转录过程中,每份纸质表格还产生了额外的0.7个错误。总体而言,每份纸质表格有1.6个错误,每份PDA表格有0.2个错误(p < 0.001)。
使用基于PDA的数据收集工具进行临床研究可减少数据收集所需时间,并显著提高数据完整性。