A comparative effectiveness study of eSource used for data capture for a clinical research registry

被引:24
作者
Nordo, Amy Harris [1 ]
Eisenstein, Eric L. [2 ]
Hawley, Jeffrey [1 ]
Vadakkeveedu, Sai [1 ]
Pressley, Melissa [1 ]
Pennock, Jennifer [1 ]
Sanderson, Iain [1 ]
机构
[1] Duke Univ, Sch Med, Off Res Informat, 2424 Erwin Rd, Durham, NC 27701 USA
[2] Duke Univ, Clin Res Inst, 2400 Pratt St,Terrace Level 0311, Durham, NC 27705 USA
关键词
Data accuracy; Data collection; Data retrieval; Information extraction; Registries; Time-motion analysis; TRIAL;
D O I
10.1016/j.ijmedinf.2017.04.015
中图分类号
TP [自动化技术、计算机技术];
学科分类号
0812 ;
摘要
Objective: This pilot study compared eSource-enabled versus traditional manual data transcription (non-eSource methods) for the collection of clinical registry information. The primary study objective was to compare the time spent completing registry forms using eSource versus non-eSource methods The secondary objectives were to compare data quality associated with these two data capture methods and the flexibility of the workflows. This study directly addressed fundamental questions relating to eSource adoption: what time-savings can be realized, and to what extent does eSource improve data quality. Materials and methods: The study used time and motion methods to compare eSource versus non-eSource data capture workflows for a single center OB/GYN registry. Direct observation by industrial engineers using specialized computer software captured keystrokes, mouse clicks and video recordings of the study team in their normal work environment completing real-time data collection. Results: The overall average data capture time was reduced with eSource versus non-eSource methods (difference, 151 s per case; eSource, 1603 s; non-eSource, 1754 s; p = 0.051). The average data capture time for the demographic data was reduced (difference, 79 s per case; eSource, 133 s; non-eSource, 213 s; p < 0.001). This represents a 37% time reduction (95% confidence interval 27% to 47%). eSourced data field transcription errors were also reduced (eSource, 0%; non-eSource, 9%). Conclusion: The use of eSource versus traditional data transcription was associated with a significant reduction in data entry time and data quality errors. Further studies in other settings are needed to validate these results.
引用
收藏
页码:89 / 94
页数:6
相关论文
共 17 条
[1]  
Botsis Taxiarchis, 2010, Summit Transl Bioinform, V2010, P1
[2]  
[Center for Drug Evaluation and Research (CDER) Food and Drug Administration U. S. Department of Health and Human Services], 2016, US EL HLTH REC DAT C
[3]   Sensible approaches for reducing clinical trial costs [J].
Eisenstein, Eric L. ;
Collins, Rory ;
Cracknell, Beena S. ;
Podesta, Oscar ;
Reid, Elizabeth D. ;
Sandercock, Peter ;
Shakhov, Yuriy ;
Terrin, Michael L. ;
Sellers, Mary Ann ;
Califf, Robert M. ;
Granger, Christopher B. ;
Diaz, Rafael .
CLINICAL TRIALS, 2008, 5 (01) :75-84
[4]  
El Fadly AbdenNaji, 2011, J Biomed Inform, V44 Suppl 1, pS94, DOI 10.1016/j.jbi.2011.07.007
[5]   The clinical document architecture and the continuity of care record: A critical analysis [J].
Feranti, Jeffrey M. ;
Musser, R. Clayton ;
Kawamoto, Kensaku ;
Hammond, W. Ed .
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION, 2006, 13 (03) :245-252
[6]   Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction [J].
Frobert, Ole ;
Lagerqvist, Bo ;
Olivecrona, Goran K. ;
Omerovic, Elmir ;
Gudnason, Thorarinn ;
Maeng, Michael ;
Aasa, Mikael ;
Angeras, Oskar ;
Calais, Fredrik ;
Danielewicz, Mikael ;
Erlinge, David ;
Hellsten, Lars ;
Jensen, Ulf ;
Johansson, Agneta C. ;
Karegren, Amra ;
Nilsson, Johan ;
Robertson, Lotta ;
Sandhall, Lennart ;
Sjogren, Iwar ;
Ostlund, Ollie ;
Harnek, Jan ;
James, Stefan K. .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (17) :1587-1597
[7]   Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance [J].
Getz, Kenneth .
INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH, 2014, 11 (05) :5069-5080
[8]   Research electronic data capture (REDCap)-A metadata-driven methodology and workflow process for providing translational research informatics support [J].
Harris, Paul A. ;
Taylor, Robert ;
Thielke, Robert ;
Payne, Jonathon ;
Gonzalez, Nathaniel ;
Conde, Jose G. .
JOURNAL OF BIOMEDICAL INFORMATICS, 2009, 42 (02) :377-381
[9]  
Hulley S. B., 2017, DESIGNING CLIN RES E
[10]  
Hulley S.B., 2001, Designing clinical research, V2nd, DOI DOI 10.1016/j.neuroimage.2007.12.053