Heiberg Turid, Kvien Tore K, Dale Øystein, Mowinckel Petter, Aanerud Gerd J, Songe-Møller Ann B, Uhlig Till, Hagen Kåre B
Centre for Education and Skill Training, Ulleval University Hospital, Oslo, Norway.
Arthritis Rheum. 2007 Apr 15;57(3):454-60. doi: 10.1002/art.22613.
The patient perspective workshops at the Outcome Measures in Rheumatology Clinical Trials have included daily measures of health status (patient diary) and use of electronic tools for data collection in the research agenda. The objective of this study was to compare daily and weekly registrations of self-reported health status measures between personal digital assistant (PDA) and paper-pencil (PP) format regarding scores, variation, and feasibility.
Thirty-eight patients with stable rheumatoid arthritis recorded their health status during 84 days in a repeated crossover design, using PDA or PP format during four 21-day periods. Visual analog scales (VAS) for pain, fatigue, and global disease and the Rheumatoid Arthritis Disease Activity Index were scored daily; the Short Form 36 and Modified Health Assessment Questionnaire were scored weekly.
The average scores and measures of variation of the 4 daily health status measures over 21 days did not differ significantly between PDA and PP formats in either of the 2 crossover periods. The values for the average range between the maximum and minimum values for daily measures were similar between the 2 formats, but showed considerable variation (e.g., range for pain VAS was 19-28 mm over each 21-day period). The time to complete the instruments was similar between the 2 formats. Missing daily data entries were generally low for both periods and somewhat higher for PDA. The majority of patients (82.9%) preferred using PDA.
Daily assessments with PDA may be efficiently used for frequent data collection because this format performs similarly to the traditional PP format.
风湿病临床试验结果测量中的患者视角研讨会纳入了健康状况的每日测量（患者日记）以及在研究议程中使用电子工具进行数据收集。本研究的目的是比较个人数字助理（PDA）和纸笔（PP）格式在自我报告健康状况测量的每日和每周记录方面在分数、变异性和可行性上的差异。
38例稳定型类风湿关节炎患者采用重复交叉设计，在84天内记录其健康状况，在四个21天周期内分别使用PDA或PP格式。每日记录疼痛、疲劳和整体疾病的视觉模拟量表（VAS）以及类风湿关节炎疾病活动指数；每周记录简短健康调查问卷36项版（SF-36）和改良健康评估问卷（MHAQ）。
在两个交叉周期中的任何一个周期，PDA和PP格式在21天内4项每日健康状况测量的平均分数和变异测量值均无显著差异。两种格式每日测量的最大值和最小值之间的平均范围值相似，但显示出相当大的变异性（例如，每个21天周期疼痛VAS的范围为19 - 28毫米）。两种格式完成问卷的时间相似。两个周期中每日数据缺失记录总体较低，PDA的略高。大多数患者（82.9%）更喜欢使用PDA。
使用PDA进行每日评估可有效用于频繁的数据收集，因为这种格式与传统的PP格式表现相似。
