Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study.
BACKGROUND
The choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study.


METHODS
A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859), at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR) system was developed using a modified version of the EDC.


RESULTS
Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites.


CONCLUSIONS
Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.
Thwin
Soe Soe
SS
Geriatrics Section, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA. sst@bu.edu
Clough-Gorr
Kerri M
KM
McCarty
Maribet C
MC
Lash
Timothy L
TL
Alford
Sharon H
SH
Buist
Diana S M
DS
Enger
Shelley M
SM
Field
Terry S
TS
Frost
Floyd
F
Wei
Feifei
F
Silliman
Rebecca A
RA
D000368:Aged; D035843:Biomedical Research; D001943:Breast Neoplasms / Q000453:epidemiology*; D015331:Cohort Studies; D003625:Data Collection / Q000379:methods*; D003628:Database Management Systems; D001330:Electronic Data Processing / Q000379:methods*; D005260:Female; D006801:Humans; D015588:Observer Variation; D009936:Organizational Innovation; D015203:Reproducibility of Results; D012107:Research Design