| アブストラクト | 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 (generalizability) 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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| ジャーナル名 | Journal of the American Medical Informatics Association : JAMIA |
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| 投稿日 | 2005/7/29 |
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| 投稿者 | Mosis, Georgio; Vlug, Albert E; Mosseveld, Mees; Dieleman, Jeanne P; Stricker, Bruno C; van der Lei, Johan; Sturkenboom, Miriam C J M |
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| 組織名 | Department of Medical Informatics, Erasmus University Medical Center Rotterdam,;Rotterdam, the Netherlands. g.mosis@gmail.com |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/16049228/ |
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