Dale Oystein, Hagen Kaare Birger
Norwegian National Centre for Assistive Technology, SIKTE, Rikstrygdeverket, Pb 5200 Nydalen, 0425 Oslo, Norway.
J Clin Epidemiol. 2007 Jan;60(1):8-17. doi: 10.1016/j.jclinepi.2006.04.005. Epub 2006 Aug 30.
To assess how personal digital assistants (PDAs) perform as collection tools of patient-reported outcomes in clinical research compared to pen and paper (P&P) diaries in terms of feasibility, protocol compliance, data accuracy, and subject acceptability.
A systematic review of randomized and quasi-randomized controlled trials comparing the PDA and P&P methods in a health diary context involving repeated measures in persons with chronic health problems.
Nine studies were included. Their methodological quality was variable. Five studies reported on feasibility, and all reported technical difficulties with the PDA technology. Two studies reported that electronic collection leads to a substantial reduction in time used for data handling. Five studies reported that the PDA method results in better compliance, whereas one study reported the opposite. All three articles reporting on data accuracy indicated that there are fewer errors in the PDA records. Four articles scrutinized subject preference, and the PDA method came out favorably in all four.
The PDA method seems to perform better than P&P in most of the selected outcomes. Technical malfunction is the chief disadvantage with the PDA method. Further research comparing PDA with paper data collection using more stringent methodology is needed.
评估在临床研究中,相较于纸笔(P&P)日记,个人数字助理(PDA)作为患者报告结局的收集工具,在可行性、方案依从性、数据准确性和受试者可接受性方面的表现。
对随机和半随机对照试验进行系统评价,比较在涉及慢性健康问题患者重复测量的健康日记情境下PDA和P&P方法。
纳入9项研究。其方法学质量参差不齐。5项研究报告了可行性,均报告了PDA技术存在技术困难。2项研究报告电子收集可大幅减少数据处理所用时间。5项研究报告PDA方法导致更好的依从性,而1项研究报告结果相反。所有3篇关于数据准确性的文章均表明PDA记录中的错误较少。4篇文章审视了受试者偏好,PDA方法在所有4篇文章中均表现良好。
在大多数选定的结局方面,PDA方法似乎比P&P表现更好。技术故障是PDA方法的主要缺点。需要使用更严格的方法对PDA与纸质数据收集进行进一步研究。