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      Standards for Reporting Implementation Studies (StaRI) Statement

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          Abstract

          Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aimed to develop guidelines for transparent and accurate reporting of implementation studies. Informed by the findings of a systematic review and a consensus-building e-Delphi exercise, an international working group of implementation science experts discussed and agreed the StaRI Checklist comprising 27 items. It prompts researchers to describe both the implementation strategy (techniques used to promote implementation of an underused evidence-based intervention) and the effectiveness of the intervention that was being implemented. An accompanying Explanation and Elaboration document (published in BMJ Open, doi: 10.1136/bmjopen-2016-013318) details each of the items, explains the rationale, and provides examples of good reporting practice. Adoption of StaRI will improve the reporting of implementation studies, potentially facilitating translation of research into practice and improving the health of individuals and populations.

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          Most cited references5

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          The PRECIS-2 tool: designing trials that are fit for purpose.

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            A Framework for Enhancing the Value of Research for Dissemination and Implementation.

            A comprehensive guide that identifies critical evaluation and reporting elements necessary to move research into practice is needed. We propose a framework that highlights the domains required to enhance the value of dissemination and implementation research for end users. We emphasize the importance of transparent reporting on the planning phase of research in addition to delivery, evaluation, and long-term outcomes. We highlight key topics for which well-established reporting and assessment tools are underused (e.g., cost of intervention, implementation strategy, adoption) and where such tools are inadequate or lacking (e.g., context, sustainability, evolution) within the context of existing reporting guidelines. Consistent evaluation of and reporting on these issues with standardized approaches would enhance the value of research for practitioners and decision-makers.
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              Phase IV implementation studies. The forgotten finale to the complex intervention methodology framework.

              The complex intervention methodology framework defines the iterative process for developing and evaluating complex interventions in healthcare, but advice on implementation research was not included until the 2008 update. Our recent systematic review of implementation studies identified significant problems with reporting standards, including inconsistent terminology and crucial information that was missing or unclear. Introduction of reporting checklists has standardized the reporting of randomized controlled trials and other types of studies, and there is a need for similar guidance for reporting implementation studies. Key standards might include an explicit evidence base from a randomized controlled trial or guideline recommendation; recruitment to the clinical service, not the research; at least some outcomes at the population level using routinely collected data; and a description of the setting and the process of implementing the service. The complex intervention framework currently illustrates a cycle of development and evaluation, which includes implementation as a final step. We propose that the research underpinning implementation should be visualized as a second interrelated cycle. Just as the "phase III cycle" includes the iterative steps of development and piloting, a similar process may be needed to translate the intervention into a practical service that can be tested in a phase IV implementation study.
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                Author and article information

                Contributors
                Role: professor of primary care respiratory medicine
                Role: senior scientist, head of Child and Youth Mental Health Research Unit
                Role: associate professor, emergency medicine
                Role: professor of biostatistics
                Role: head of unit, coordinator of primary health care research, Biocruces Research Institute
                Role: professor of primary care
                Role: pro-vice chancellor, research and impact
                Role: director of research program development
                Role: professor of ehealth and primary care, and head of research
                Role: professor of health economics
                Role: director
                Role: professor in public health and primary care
                Journal
                BMJ
                BMJ
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2017
                06 March 2017
                : 356
                : i6795
                Affiliations
                [1 ]Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh EH8 9AG, UK
                [2 ]Research Institute, Hospital for Sick Children; Department of Psychiatry and Dalla Lana School of Public Health, University of Toronto, Canada
                [3 ]Washington University Division of Emergency Medicine. Washington University School of Medicine in St Louis, USA
                [4 ]Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, UK
                [5 ]Primary Care Research Unit of Bizkaia, Basque Health Service, Spain
                [6 ]Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, UK
                [7 ]Bangor Institute for Health & Medical Research, Bangor University, UK
                [8 ]Montefiore Medical Center, The University Hospital for Albert Einstein College of Medicine, New York, USA
                [9 ]Research Department of Primary Care and Population Health, University College London, UK
                Author notes
                Correspondence to: H Pinnock hilary.pinnock@ 123456ed.ac.uk
                Article
                pinh034338
                10.1136/bmj.i6795
                5421438
                28264797
                248efe1e-74b9-4b5c-b118-3fc9fa73ff43
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 27 October 2017
                Categories
                Research Methods & Reporting

                Medicine
                Medicine

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