Analysis the method of data collection in clinical trials
- VernacularTitle:临床试验数据收集的方法分析
- Author:
Yan-Bo LIU
1
;
Chong-Chao YAN
;
Zhen-Hua XIN
;
Wen-Fu TAN
Author Information
1. 复旦大学 药学院 药理学系
- Keywords:
electronic patient reported outcome;
patient reported outcome;
visual function questionnaire;
data quality
- From:
The Chinese Journal of Clinical Pharmacology
2014;(4):357-359,376
- CountryChina
- Language:Chinese
-
Abstract:
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.
