Randomised database studies can be considered a special form of an LST where patients included in the trial are enrolled in a healthcare system with electronic records. Eligible patients may be identified and flagged automatically by the software, with the advantage of allowing comparison of included and non-included patients. Database screening or record linkage can be used to detect and measure outcomes of interest otherwise assessed through the normal process of care. Patient recruitment, informed consent and proper documentation of patient information are hurdles that still need to be addressed in accordance with the applicable legislation for RCTs. Randomised database studies attempt to combine the advantages of randomisation and observational database studies. These and other aspects of randomised database studies are discussed in The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials (Health Technol Assess. 2014;18(43):1-146) which illustrates the practical implementation of randomised studies in general practice databases.
There are few published examples of randomised database studies, but this design could become more common in the near future with the increasing computerisation of medical records. Pragmatic randomised trials using routine electronic health records: putting them to the test (BMJ 2012;344:e55) describes a project to implement randomised trials in the everyday clinical work of general practitioners, comparing treatments that are already in common use, and using routinely collected electronic healthcare records both to identify participants and to gather results.
Another use of databases in RCT is the long-term follow-up of patients in observational studies after RCT termination, for example to assess long-term safety and effectiveness at regular intervals using objective outcomes. The TASTE trial is an example of trial that followed patients long-term using routinely collected data (Thrombus aspiration during ST-segment elevation myocardial infarction. N. Engl J Med. 2013;369(17):1587-97).
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|