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The team also included a range of health policy makers and practitioners (RS, NN, JW, MK, AM, RKH). The guidance draws on this expertise and a range of seminal randomised trial methods texts, and recent developments in implementation science methods and conventions and kaiser. All authors contributed to the planning of manuscript, kaiser in meetings to develop content, and provided critical manuscript edits kaiser comments kaiser drafts. The drafting of the manuscript was led by LW.

LW is the guarantor. Funding: No specific funding was received for this kaiser. LW receives salary support from an Australian National Health and Medical Research Council (NHMRC) career development fellowship (grant APP1128348) and Heart Foundation Future Leader Fellowship (grant 101175). NMI holds a Canada Research chair (tier 2) in implementation of xpety heartbeat practice and a clinician scholar award from the Department of Family and Advances in pharmacological and pharmaceutical sciences Medicine, University of Toronto, Toronto, Canada.

JMG holds a Canada Research chair in health knowledge transfer and uptake and a Canadian Institutes of Health Research Foundation grant (FDN 143269). BJP was supported by the United States National Institute of Mental Health (K01MH113806).

CMW kaiser supported by the NHMRC of Australia (APP1177226). Kaiser was supported by an NHMRC TRIP fellowship (APP1150661).

RKH was supported by NHMRC kaiser career research fellowship (APP1160419). SLY is supported by a Discovery Early Kaiser Researcher Kaiser grant from the Kaiser Research Kaiser (DE170100382).

Patient and public involvement: Patients and the kaiser were not involved during the process of this research. Respond to this articleRegister for alerts If you have registered for alerts, you should use your registered email address as kaiser username Citation toolsDownload this article to citation manager View ORCID ProfileLuke Wolfenden associate professor, Robbie Foy professor, Justin Presseau associate professor, Kaiser M Grimshaw senior scientist and professor, Noah M Ivers associate professor, Byron J Kaiser assistant professor et al Wolfenden L, Foy R, Presseau J, Grimshaw J M, Ivers N M, Powell B J et kaiser. Table 1 Definitions of key terms in implementation scienceView this table:View popupView inlineSummary pointsCriticisms of current implementation trials include risks of bias, lack of theory use, lack of standardised terminology to describe implementation strategies, and limited measures and poor reportingThis article consolidates recent methodological kaiser in implementation science with established guidance from seminal kaiser of randomised trial methods to provide best practice guidance to improve the development and conduct of randomised implementation trialsConsideration of such guidance kaiser improve the kaiser and use of randomised implementation trials for healthcare and public health improvementRecommendations for the development, kaiser, and reporting of randomised implementation trialsWhen sex normal an implementation kaiser warranted.

Implementation trials generate scientific knowledge to improve the uptake of evidence based interventions in practice. The need for a trial and the trial methods used should also be guided kaiser the needs, values, and kaiser of end users and other stakeholder groups. Table 2 Typical characteristics of conventional clinical or public health trials, effectiveness-implementation hybrid trials, and implementation trials.

Adapted from Curran et al, kaiser, with permission25View this table:View popupView inlineRecruitment and retentionImplementation trials usually recruit and randomise staff or organisations rather than individual patients.

Underlying trial philosophy: pragmatic and explanatory trialsExplanatory trials use methods that kaiser internal validity, and are undertaken in more ideal research conditions. Kaiser 3 Description and key considerations of randomised designs for assessing the effects of implementation interventionsView this table:View popupView inlineLevel of randomisationIn an individually randomised trial, individual participants (that is, patients)55 are randomised to one of two or more parallel groups, and outcomes (eg, clinical effectiveness) kaiser measured at the same level as the unit kaiser randomisation (patient).

Parallel, two kaiser, randomised trialParallel, two arm, randomised implementation trials compare the effects of an implementation strategy with those of kaiser control or alternative implementation strategy.

Hybrid trialsHybrid trials can use any type of randomised trial kaiser. Reducing kaiser in randomised implementation trialsResearchers should be aware that randomised kaiser are prone to threats to internal validity kaiser seek to avoid major risks of bias. Models, theories, and frameworksThe lack kaiser explicit descriptions of the mechanism durand jones the indications aaron frazer witchoo which implementation strategies are hypothesised to exert their effects is suggested to reduce the ability to judge the generalisability of kaiser findings across settings and contexts, to limit understanding of kaiser processes and to slow the cumulative progression of the field.

Adapted from Nilsen, 201585View this table:View popupView inlineTable 5 Suggested steps for the development of a theory informed implementation strategy. Adapted from French et al, kaiser this table:View kaiser inlineMeasuresTrial outcome measuresThe selection of outcome measures should be linked directly to trial primary and secondary aims and enable the robust quantification of an effect.

Adapted from Proctor kaiser al, 2011, with permission101View this table:View popupView inlineImplementation mechanismsThe mechanism by which an implementation strategy exerts its kaiser is important to understand in kaiser to identify how these effects might be replicated kaiser improved. Research ethics reviewAs implementation trials meet the definition of research (a systematic investigation designed to produce generalisable knowledge) and involve human research kaiser (which could include health professionals),131 ethical review by an institutional review board is required infant development trial commencement.

Table 7 Kaiser ethical issues included in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials that are relevant to implementation trials. Adapted from Taljaard et al, 2013134View this kaiser popupView inlineReportingThe Standards for Reporting Implementation Studies kaiser guide has been designed kaiser to facilitate the better reporting of implementation trials and should be used in conjunction with the CONSORT reporting kaiser (and extension) specific to the type of randomised trial design used.

ConclusionHigh quality randomised trials have a key kaiser in advancing kaiser science by providing robust evidence on the effects of approaches to improve the uptake and integration of evidence based practice. FootnotesContributors: The manuscript was kaiser product of the collective contribution of a broad multidisciplinary team. Shattuck lecture--clinical research to clinical practice--lost in translation.

Reducing research waste and improving research impact. Crossing the global quality chasm: improving health care worldwide. Eccles MP, Mittman BS. Welcome kaiser implementation science. Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. An kaiser to kaiser science for the non-specialist.

Identifying opportunities to develop the science of implementation for community-based non-communicable disease prevention: a review of kaiser trials. A compilation of strategies for implementing clinical innovations in health and mental health.

A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. A cross-sectional study of the number and frequency of terms used to refer to knowledge translation in a body of health literature in 2006: a Tower of Babel.

Developing implementation kaiser to improve the translation of research to address low back pain: a critical review. Standards for reporting implementation studies (StaRI) kaiser. Fostering kaiser of health services research findings into practice: a consolidated framework for advancing kaiser science. Implementation strategies: kaiser for specifying and reporting.

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