Implementation science in hybrid randomized controlled trials: a state-of-the-art systematic review.
Introduction: Hybrid randomized controlled trials (RCTs) combine effectiveness and implementation aims to accelerate evidence translation. As this is a new yet evolving methodology, it is timely to review the characteristics and reporting quality of hybrid RCTs, and how implementation science theori...
| Publicado en: | JBI Evidence Implementation Vol. 24; no. 3; pp. 634 - 652 |
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| Autores principales: | , , , , , , , |
| Formato: | research systematic review tables/charts Journal Article |
| Publicado: |
Lippincott Williams & Wilkins
Jul2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=195416599&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 195416599 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 26913321 MO0F jtl: JBI Evidence Implementation issn: 26913321 maglogo: N pubinfo: dt: Jul2026 vid: 24 iid: 3 pid: 433 pub: Lippincott Williams & Wilkins place: Baltimore, Maryland artinfo: ui: 195416599 195416599 195416599 10.1097/XEB.0000000000000568 195416599 ppf: 634 ppct: 18 formats: tig: atl: Implementation science in hybrid randomized controlled trials: a state-of-the-art systematic review. aug: au: Liu, Mark G Comber, Elouise Martin, Andrew Roberts, Natasha Trott, Mike Costa, Nathalia Foster, Nadine E Hickman, Ingrid J affil: ULTRA, The University of Queensland Clinical Trials Capability, Centre for Clinical Research, Brisbane, Qld, Australia sug: subj: Implementation Science Randomized Controlled Trials Study Design Human Systematic Review Models, Theoretical Quality of Health Care Mental Health Primary Health Care Community Health Services Abstracts Medline Citation Analysis Checklists Life Style Sample Size Nomenclature Descriptive Statistics Data Analysis Software ab: Introduction: Hybrid randomized controlled trials (RCTs) combine effectiveness and implementation aims to accelerate evidence translation. As this is a new yet evolving methodology, it is timely to review the characteristics and reporting quality of hybrid RCTs, and how implementation science theories, models and frameworks (TMFs) have been used in this context. Methods: Citation-indexed databases (Web of Science, Scopus) were searched from 2012 (inception of "hybrid" terminology) to 2025 for RCTs that were identified as "hybrid" in the title/abstract/keywords and that cited and applied a TMF. RCT design and implementation characteristics were extracted and analyzed descriptively. Reporting quality assessment followed the Standards for Reporting Implementation Studies (StaRI). Results: Of the 1,846 initial hits, 111 papers were included, comprising 52 main results papers, 37 protocols, and 22 secondary papers. Most RCTs were published in the past 5 years (79%), conducted in North America (62%), in primary care/community settings (50%), and calculated sample sizes using the clinical effectiveness outcome (64%). TMFs were mostly used to inform implementation outcomes (88%) versus implementation strategies (52%). The most common TMFs were the Reach, Effectiveness, Adoption, Implementation, Maintenance Framework (RE-AIM) (44%) and Proctor's taxonomy of implementation outcomes (29%). Reporting quality was stronger for clinical intervention components, with fewer RCTs reporting the rationale and fidelity of implementation strategies (27%) compared to the clinical intervention (60%). Conclusions: Hybrid RCTs that apply TMFs are increasing, yet there is evidence that maturation is warranted. Clinical effectiveness rather than implementation remains the focus of most hybrid RCTs. More deliberate application and reporting of implementation science TMFs may improve the quality of future hybrid RCTs. http://links.lww.com/IJEBH/A518 pubtype: Academic Journal doctype: research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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