Abstract
Background
Collection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal.
Questions/purposes
Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system.
Where are we now?
Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems.
Where do we need to go?
To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process.
How do we get there?
Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.
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References
Bart T. Comparison of electronic data capture with paper data collection. Business briefing: Pharmatech, 2003 Available at: http://www.dreamslab.it/doc/eclinica.pdf. Accessed: June 22, 2010.
Black N. High-quality clinical databases: breaking down barriers. Lancet. 1999;353:1205–1206.
Brown EG, Holmes BJ, McAulay SE. Clinical Trials’ EDC Endgame. New York, NY: Forrester Research, Inc; 2004.
CFR - Code of Federal Regulations Title 21. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11. Accessed February 1, 2010.
CliniProteus. Available at: http://www.rfdn.org/bioinfo/CTMS/ctms.html. Accessed February 1, 2010.
Clinsys® Clinical Research. Available at: http://www.clinsys.com/. Accessed February 1, 2010.
Dados Prospective, Duke University Version 2.1. Available at: https://www.ceso.duke.edu/dados2.1/servlet/Controller. Accessed February 1, 2010.
DATATRAK One™. Available at: http://www.datatrak.net/products/electronic-data-capture/. Accessed June 1, 2010.
De Lusignan S, van Weel C. The use of routinely collected computer data for research in primary care: opportunities and challenges. Fam Pract. 2006;23:253–263.
Entrypoint Plus®. Available at: http://www.entrypointplus.com/audit_trail.htm. Accessed February 1, 2010.
eTrials EDC, Merge Healthcare, Available at: http://www.merge.com/products/etrials/trial-intelligence/index.aspx. Accessed June 1, 2010.
Eugene CN, Mark ES, Paul BB, Stephen KP. Building measurement and data collection into medical practice. Ann Intern Med. 1998;128:460–466.
Fegan GW, Lang TA. Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Med. 2008;5:e6–e6.
GNU General Public License. Available at: http://en.wikipedia.org/wiki/GNU_General_Public_License. Accessed February 1, 2010.
GPL 2. Available at: http://www.gnu.org/licenses/gpl.html. Accessed February 1, 2010.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–381.
Hashkes PJ, Uziel Y, Rubenstein M. The Israeli Internet-based registry: novel concept of multicenter data collection in pediatric rheumatology. Pediatr Rheumatol Online J. 2004;2:37–50. Available at: http://www.pedrheumonlinejournal.org/Jan-Feb/PDF/registry.pdf. Accessed June 22, 2010.
Helms RW. Data quality issues in electronic data capture. Drug Inf J. 2001;35:827–837.
Herberts P, Malchau H. How outcome studies have changed total hip arthroplasty practices in Sweden. Clin Orthop Relat Res. 1997;344:44–60.
Herberts P, Malchau H. Many years of registration have improved the quality of hip arthroplasty [in Swedish]. Läkartidningen. 1999;96:2469–2473, 2475–2476
Herberts P, Malchau H. Long-term registration has improved the quality of hip replacement: a review of the Swedish THR Register comparing 160,000 cases. Acta Orthop Scand. 2000;71:111–121.
InFormTM Available at: http://www.phaseforward.com/products/clinical/edc/default.aspx. Accessed February 1, 2010.
Keramaris NC, Kanakaris NK, Tzioupis C, Kontakis G, Giannoudis PV. Translational research: from benchside to bedside. Injury. 2008;39:643–650.
Koop A, Mösges R. The use of handheld computers in clinical trials. Control Clin Trials. 2002;23:469–480.
Kush RD, Bleicher P, Kubick WR, Kush ST, Marks R, Raymond SA, Tardiff B. eClinical Trials: Planning and Implementation. Boston, MA: CenterWatch; 2003.
Lang M, Kirpekar N, Bürkle T, Laumann S, Prokosch HU. Results from data mining in a radiology department: the relevance of data quality. Stud Health Technol Inform. 2007;129(Pt 1):576–580.
Litchfield J, Freeman J, Schou H, Elsley M, Fuller R, Chubb B. Is the future for clinical trials internet-based? A cluster randomized clinical trial. Clin Trials (London, England). 2005;2:72–79.
Nguyen L, Shah A, Harker M, Martins H, McCready M, Menezes A, Jacobs D, Pietrobon R. DADOS-Prospective: an open source application for Web-based prospective data collection. Source Code Biol Med. 2006;1:7.
Nutting PA. Practice-based research networks answer primary care questions. JAMA. 1999;281:686–688.
OpenClinica®. Open source for clinical research. Available at: http://www.openclinica.org/. Accessed February 2010.
Oracle® Clinical. Available at: http://www.oracle.com/industries/life_sciences/oracle-clinical.html. Accessed February 2010.
Paterson D. The International Documentation and Evaluation System (IDES). Orthopedics. 1993;16:11–14.
Pavlović I, Kern T, Miklavčič D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp Clin Trials. 2009;30:300–316.
Project RedCap. Available at: http://www.project-redcap.org/videos.php. Accessed: June 22, 2010 .
Prokscha S. Practical Guide to Clinical Data Management. 2nd ed. Boca Raton, FL: CRC Press; 2006.
RAVE, Medidata solutions. Available at: http://www.mdsol.com/products/rave_overview.htm. Accessed February 1, 2010.
Research on Research Group. Available at: http://researchonresearch.org/. Accessed December 12, 2009.
Röder C, Eggli S, EL-Kerdi A, Müller U, Ambrose T, Röösli E, Busato A, Aebi M. The International Documentation and Evaluation System (IDES)—10-years experience. Int Orthop. 2003;27:259–261.
Röder C, El-Kerdi A, Grob D, Aebi M. A European spine registry. Eur Spine J. 2002;11:303–307.
Röder C E-Kerdi A, Frigg A, Kolling C, Staub L, Bach B. The Swiss Orthopaedic Registry. Bull Hosp Jt Dis. 2005;63:15–19.
Sujansky WV. The benefits and challenges of an electronic medical record: much more than a “word-processed” patient chart. West J Med. 1998;169:176–183.
Sussman S, Valente TW, Rohrbach LA, Skara S, Pentz MA. Translation in the health professions: converting science into action. Eval Health Prof. 2006;29:7–32.
Trial DB. Available at: http://ycmi.med.yale.edu/TrialDB/. Accessed February 2010.
Velikova G, Wright EP, Smith AB, Cull A, Gould A, Forman D, Perren T, Stead M, Brown J, Selby PJ. Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires. J Clin Oncol. 1999;17:998–998.
Welker JA. Implementation of electronic data capture systems: Barriers and solutions. Contemp Clin Trials. 2007;28:329–336.
Yackel TR. How the open-source development model can improve medical software. Stud Health Technol Inform. 2001;84(Pt 1):68–72.
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Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.
This work was performed at Duke University Medical Center, Durham, NC, USA, and Duke NUS Graduate medical School, Singapore.
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Shah, J., Rajgor, D., Pradhan, S. et al. Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery: Open Source versus Commercial Systems. Clin Orthop Relat Res 468, 2664–2671 (2010). https://doi.org/10.1007/s11999-010-1469-3
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DOI: https://doi.org/10.1007/s11999-010-1469-3