A Technical Infrastructure to Conduct Randomized Database Studies Facilitated by a General Practice Research Database: Figure 1

Abstract

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.

The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials

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Implementation of a Medical Database System for a Radiosurgery Center

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“…Widespread collection of clinical data in a computerized format, such as electronic health records (EHRs) and administrative claims, has made available an unprecedented amount of health care data for computational reuse [12]. These data promise to facilitate comparative effectiveness research, safety surveillance, and pragmatic trials, to name a few [345678]. Large clinical data research networks–here within referred to as networks–have been established to capitalize on these research opportunities [9].…”