ArticleBMC medical research methodology2025
Could master protocols be adapted for effectiveness-implementation hybrid studies?
Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
backgroundMaster protocols leverage a common trial infrastructure for launching multiple sub-studies. Translational research aims to progress scientific discoveries toward public health impact, which depends on establishing an intervention's efficacy, effectiveness in real-world conditions, and successful strategies for implementation. While master protocols have been designed to improve the efficiency of clinical trials as sub-studies addressing a particular disease, their application with effectiveness-implementation hybrid studies is yet to be explored. The aim of this study was to develop recommendations for adapting mater protocol methods for effectiveness-implementation research.
methodsA method of consultation with translational research networks was undertaken between January and December 2024. Consideration was given to the requirements for service providers to engage in translational research, and how master protocols could support effectiveness-implementation hybrid sub-studies. The underlying rationale for potential adaptations is provided with reference to implementation frameworks, discussion of advantages and disadvantages, and summary recommendations.
resultsRecommendations are proposed on establishing common trial infrastructure, aims and hypotheses, data collection, control groups, adaptive elements, and eligibility criteria. By leveraging cross-sectoral partnerships, co-producing research and dissemination, and incorporating adaptive elements, master protocols may offer a promising approach for accelerating progress along the translational research pipeline.
conclusionsThe adaptation of master protocols for hybrid sub-studies could enable evidence-based interventions to be more effectively implemented in routine care settings. The feasibility of master protocols for effectiveness-implementation research is yet to be tested, and further development in this area is needed to trial the proposed methodology.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.