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First published July 27, 2005 as JAMIA PrePrint; doi:10.1197/jamia.M1803
Journal of the American Medical Informatics Association 2005;12(6):602-607
© 2005 American Medical Informatics Association

A more recent version of this article appeared on November 1, 2005
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Submitted on January 31, 2005
Accepted on July 27, 2005

A Technical Infrastructure to Conduct Randomized Database Studies Facilitated by a General Practice Research Database

Georgio Mosis MSc1*, Albert E. Vlug MSc, MA2, Mees Mosseveld MSc2, Jeanne P. Dieleman PhD1, Bruno Ch Stricker MD, PhD3, Johan van der Lei MD, PhD4, and Miriam CJM Sturkenboom PharmD, PhD5

Affiliation of the authors: 1 Department of Medical Informatics, Department of Epidemiology and Biostatistics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands; 2 Department of Medical Informatics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands; 3 Department of Epidemiology and Biostatistics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands; 4 Department of Medical Informatics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands ; 5 Department of Medical Informatics, Department of Epidemiology and Biostatistics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands

* To whom correspondence should be addressed.

General practice research databases are increasingly used to study intended and unintended effects of treatments. However, confounding by indication remains a major problem. The randomized database study methodology has been proposed as a method to combine the strengths of observational database (generalisability) and the strength of the randomized clinical trial (RCT) design (randomization). We developed an infrastructure that enables the execution of randomized database studies with treatment randomization facilitated by a general practice research database. The requirements posed by the methodology of randomized database studies were facilitated by software components. Our assessment showed that it is technically possible to conduct randomized trials in general practice according to the randomized database design. The infrastructure facilitated the conduct of randomized database studies in general practice but some practical difficulties and methodological issues remain. The technical infrastructure seems to be both promising and potentially feasible to facilitate future randomized database studies, although the methodology needs to be evaluated in more detail.




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