期刊
JOURNAL OF CLINICAL EPIDEMIOLOGY
卷 159, 期 -, 页码 330-343出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2023.04.015
关键词
Registries; Randomized controlled trials; Registry-based randomized controlled trials; RRCTs; Strengths and limitations; Best practice
This article provides insights for future Registry-based randomized controlled trials (RRCTs) by analyzing the strengths and limitations reported in planned and completed RRCTs. The study identified six main RRCT strengths and four main RRCT limitations, and formulated ten recommendations for future RRCTs.
Objectives: Registry-based randomized controlled trials (RRCTs) are increasingly used, promising to address challenges associated with traditional randomized controlled trials. We identified strengths and limitations reported in planned and completed RRCTs to inform future RRCTs.Study Design and Setting: We conducted an environmental scan of literature discussing conceptual or methodological strengths and limitations of using registries for trial design and conduct (n = 12), followed by an analysis of RRCT protocols (n = 13) and reports (n = 77) identified from a scoping review. Using framework analysis, we developed and refined a conceptual framework of RRCT-specific strengths and limitations. We mapped and interpreted strengths and limitations discussed by authors of RRCT articles using frame -work codes and quantified the frequencies at which these were mentioned.Results: Our conceptual framework identified six main RRCT strengths and four main RRCT limitations. Considering implications for RRCT conduct and design, we formulated ten recommendations for registry designers, administrators, and trialists planning future RRCTs.Conclusion: Consideration and application of empirically underpinned recommendations for future registry design and trial conduct may help trialists utilize registries and RRCTs to their full potential. & COPY; 2023 Elsevier Inc. All rights reserved.
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