摘要
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＆lt;0.05 ） , patients without questionnaire data in PRO group were fewer than in EPRO group （ P＆lt;0.05 ） , patients with ex-tra questionnaires in PRO group were fewer than in EPRO group （ P＆lt;0.05 ） , and patients in PRO group with questionnaires being collected later than the last visit date were fewer than in EPRO group （ P ＆lt;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＆lt;0.05 ） , and questionnaires with discrepancy in EPRO group were fewer than in PRO （ P ＆lt;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.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2014年第4期357-359,376,共4页
The Chinese Journal of Clinical Pharmacology
