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      Reflections on 10 years of effectiveness-implementation hybrid studies

      brief-report

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          Abstract

          This article provides new reflections and recommendations from authors of the initial effectiveness-implementation hybrid study manuscript and additional experts in their conceptualization and application. Given the widespread and continued use of hybrid studies, critical appraisals are necessary. The article offers reflections across five conceptual and methodological areas. It begins with the recommendation to replace the term “design” in favor of “study.” The use of the term “design” and the explicit focus on trial methodology in the original paper created confusion. The essence of hybrid studies is combining research questions concerning intervention effectiveness and implementation within the same study, and this can and should be achieved by applying a full range of research designs. Supporting this recommendation, the article then offers guidance on selecting a hybrid study type based on evidentiary and contextual information and stakeholder concerns/preferences. A series of questions are presented that have been designed to help investigators select the most appropriate hybrid type for their study situation. The article also provides a critique on the hybrid 1-2-3 typology and offers reflections on when and how to use the typology moving forward. Further, the article offers recommendations on research designs that align with each hybrid study type. Lastly, the article offers thoughts on how to integrate costs analyses into hybrid studies.

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          Most cited references58

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          Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

          Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. 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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            Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

            This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.
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              The PRECIS-2 tool: designing trials that are fit for purpose.

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                Author and article information

                Contributors
                Journal
                Front Health Serv
                Front Health Serv
                Front. Health Serv.
                Frontiers in Health Services
                Frontiers Media S.A.
                2813-0146
                08 December 2022
                2022
                : 2
                : 1053496
                Affiliations
                [1] 1Department of Pharmacy Practice, University of Arkansas for Medical Sciences , Little Rock, AR, United States
                [2] 2Center for Mental Health Outcomes Research, Central Arkansas Veterans Healthcare System , North Little Rock, AR, United States
                [3] 3Behavioral Health Quality Enhancement Research Initiative (QUERI), Central Arkansas Veterans Healthcare System , Little Rock, AR, United States
                [4] 4Department of Psychiatry, University of Arkansas for Medical Sciences , Little Rock, AR, United States
                [5] 5Department of Population Health Sciences, Spencer Fox Eccles School of Medicine at the University of Utah , Salt Lake City, UT, United States
                [6] 6Center for Health Promotion and Prevention Research, University of Texas , Houston, TX, United States
                [7] 7Division of Cancer Control and Population Sciences, National Cancer Institute , Rockville, MD, United States
                [8] 8Department of Research and Evaluation, Kaiser Permanente Southern California , Los Angeles, CA, United States
                Author notes

                Edited by: Ann Catrine Eldh, Linköping University, Sweden

                Reviewed by: Lauren Clack, University of Zurich, Switzerland; Lars Wallin, Dalarna University, Sweden

                *Correspondence: Sara J. Landes sjlandes@ 123456uams.edu

                This article was submitted to Implementation Science, a section of the journal Frontiers in Health Services

                †These authors share first authorship

                Article
                10.3389/frhs.2022.1053496
                10012680
                36925811
                00c4aafb-b85b-4325-9cd4-64e27bcfae5f
                Copyright © 2022 Curran, Landes, McBain, Pyne, Smith, Fernandez, Chambers and Mittman.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 25 September 2022
                : 14 November 2022
                Page count
                Figures: 1, Tables: 0, Equations: 0, References: 52, Pages: 10, Words: 7831
                Funding
                GMC and SJL are supported by the Translational Research Institute (TRI), UL1 TR003107, through the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH). SJL was supported by grants PII 19-462, QUE 20-026, and EBP 22-104 from the Department of Veterans Affairs Quality Enhancement Research Initiative. JDS was supported by grant HL154297 from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH).
                Categories
                Health Services
                Perspective

                implementation science,hybrid studies,research design,cost analysis,health services research,effectiveness-implementation hybrid

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