Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials

Publication date: Available online 22 September 2017
Source:Journal of Clinical Epidemiology
Author(s): Tim Mathes, Stefanie Buehn, Peggy Prengel, Dawid Pieper
ObjectiveTo analyze the features of registry-based randomized trials (rRCT).Study DesignWe systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics.ResultsThe search resulted in 1202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs more than one registry was utilized. Various linkage techniques were used. In median two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks-27 years). Information on quality of registry data was reported in 11.3%.ConclusionrRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning a RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis.



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