Artikel
Suggestions for a new classification of Registry-based Randomized Controlled Trials (RRCTs)
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Autoren
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Luisa Urban
- University Medical Center Göttingen, Department of Medical Statistics, Göttingen, Deutschland
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Dawid Pieper
- Brandenburg Medical School (Theodor Fontane), Faculty of Health Sciences Brandenburg, Institute for Health Services and Health System Research, Deutschland; Brandenburg Medical School (Theodor Fontane), Center for Health Services Research, Deutschland
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Tim Mathes
- University Medical Center Göttingen, Department of Medical Statistics, Göttingen, Deutschland
| Veröffentlicht: | 27. März 2025 |
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Gliederung
Text
Background/research question: Registry-based Randomized Controlled Trials (RRCTs) are gaining importance in clinical research due to their potential to generate internally valid results at reduced costs and effort compared to conventional RCTs. The possibilities and extent of using registries for RRCTs vary. However, a uniform understanding of what constitutes an RRCT and its subtypes has not yet been defined. The lack of a common understanding hinders clear communication among researchers and is likely a source of confusion. Therefore, we propose a classification of RRCTs based on the extent of registry utilization.
Methods: This work was based on a methodological review of 162 RRCTs. We extracted detailed data on different possibilities of utilizing registries for RCTs. Based on this we inductively created clusters of RRCTS with similar utilization patterns through expert consensus. For the different clusters, we suggest a classification for different RRCTs.
Results: Our classification comprises three distinct categories: extended Registry-based long-term Follow-Up (RFU-RCT), Hybrid-RRCT (HRRCT), and (real) RRCT. Each category represents a different registry usage extent and is mutually exclusive.
RFU studies utilize registry data only to extend or supplement previous conventional RCTs by using registry data and should not be labeled as RRCTs. Hybrid-RRCTs employ registry data in conjunction with classical active data collection methods, for example because of limitations in registry data quality or availability. As there is a wide variety of possible utilization possibilities, for Hybrid-RRCTs the extent of using registry data and relation to active data collection methods should be always described in depth. We suggest that for clarity only RRCTs that rely exclusively on registries for collecting both, baseline and outcome data, should be labeled as RRCTs.
Conclusion: We suggest a classification for RRCTs depending on the extent of registry utilization. More specifically, we distinct RRCTs and Hybrid-RRCTs. The classification may stimulate a common understanding, improve reporting of RRCTs, and facilitate communication between researchers.
Competing interests: The authors declare no competing interests.
