Integrating implementation science in clinical research to maximize public health impact: a call for the reporting and alignment of implementation strategy use with implementation outcomes in clinical research
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TLDR
It is argued that the lack of comprehensive reporting of implementation strategy use and alignment of those strategies with implementation outcomes within clinical research is a missed opportunity to efficiently narrow research-to-practice gaps and it is proposed that revisions to frequently used reporting guidelines in clinical research are needed.Abstract:
Although comprehensive reporting guidelines for implementation strategy use within implementation research exist, they are rarely used by clinical (i.e., efficacy and effectiveness) researchers. In this debate, we argue that the lack of comprehensive reporting of implementation strategy use and alignment of those strategies with implementation outcomes within clinical research is a missed opportunity to efficiently narrow research-to-practice gaps. We review ways that comprehensively specifying implementation strategy use can advance science, including enhancing replicability of clinical trials and reducing the time from clinical research to public health impact. We then propose that revisions to frequently used reporting guidelines in clinical research (e.g., CONSORT, TIDieR) are needed, review current methods for reporting implementation strategy use (e.g., utilizing StaRI), provide pragmatic suggestions on how to both prospectively and retrospectively specify implementation strategy use and align these strategies with implementation outcomes within clinical research, and offer a case study of using these methods. The approaches recommended in this article will not only contribute to shared knowledge and language among clinical and implementation researchers but also facilitate the replication of efficacy and effectiveness research. Ultimately, we hope to accelerate translation from clinical to implementation research in order to expedite improvements in public health.read more
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References
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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
TL;DR: The Consort 2010 Statement as discussed by the authors has been used worldwide to improve the reporting of randomised controlled trials and has been updated by Schulz et al. in 2010, based on new methodological evidence and accumulating experience.
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Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science
Laura J. Damschroder,David C. Aron,Rosalind E. Keith,Susan Kirsh,Jeffery A. Alexander,Julie C. Lowery +5 more
TL;DR: The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories.
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CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
David Moher,Sally Hopewell,Kenneth F. Schulz,Victor M. Montori,Peter C Gøtzsche,Philip J. Devereaux,Diana Elbourne,Matthias Egger,Douglas G. Altman +8 more
TL;DR: This update of the CONSORT statement improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias.
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Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide
Tammy Hoffmann,Paul Glasziou,Isabelle Boutron,Ruairidh Milne,Rafael Perera,David Moher,Douglas G. Altman,Virginia Barbour,Helen Macdonald,Marie Johnston,Sarah E Lamb,Mary Dixon-Woods,Peter McCulloch,Jeremy C Wyatt,An-Wen Chan,Susan Michie +15 more
TL;DR: The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda
Enola K. Proctor,Hiie Silmere,Ramesh Raghavan,Peter S. Hovmand,Greg Aarons,Alicia C. Bunger,Richard H Griffey,Melissa A. Hensley +7 more
TL;DR: A heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions is proposed.