论文部分内容阅读
目的：比较电话和纸质2种收集方式数据质量的优劣。方法以真实临床试验数据为基础，用电话形式的电子化患者报告的临床结局（ EPRO ）和纸质患者报告的临床结局（ PRO）2种方式，获得临床结局量表视功能问卷（ VFQ）的数据，比较2种收集方式的数据优劣。结果 PRO较优的有：无基线值患者数少于 EPRO （ P＜0.05）， PRO 无量表的患者数少于 EPRO （ P＜0.05），PRO有额外问卷的患者数少于 EPRO（P＜0.05），PRO最后的问卷晚于最后访视的患者数少于EPRO（ P＜0.05）；PRO较劣的有：PRO有缺失值的问卷数多于EPRO（P＜0.05），PRO有差异的问卷数多于 EPRO（ P＜0.05）；PRO与EPRO无差异的有：两者不在访视窗内的问卷数差别无统计学意义（P＞0.05），2者患者缺失的问卷数差别无统计学意义（P＞0.05）。结论电话EPRO收集的数据质量并没有完全优于PRO，2种收集方式在不同数据点上质量互有优劣。“,”Objective To compare the qualities of data collected by e-lectronic patient reported outcomes ( EPRO ) and patient reported out-comes(PRO) and then to provide suggestions for future use.Methods Questionnaires which collected by both paper and electronic methods based on real data of a pharmaceutical company were selected.Compa-ring data quality gained by two data -collecting methods.Results PRO data quality was significantly better than EPRO on the following data points:patients with no baseline in PRO group were fewer than in EPRO group ( P<0.05 ) , patients without questionnaire data in PRO group were fewer than in EPRO group ( P<0.05 ) , patients with ex-tra questionnaires in PRO group were fewer than in EPRO group ( P<0.05 ) , and patients in PRO group with questionnaires being collected later than the last visit date were fewer than in EPRO group ( P <0.05 ).EPRO data quality was significantly better than PRO on these data points: Questionnaires with missing value in EPRO group were fewer than in PRO ( P<0.05 ) , and questionnaires with discrepancy in EPRO group were fewer than in PRO ( P <0.05 ) .There was no significant difference between PRO and EPRO on the following points:questionnaires not within the visit window, and missing question-naires.Conclusion EPRO data quality is not better than PRO on all points, and each has superiority and inferiority on some points.