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Adapted from Nilsen, 201585Several useful resources are available to support the application of formal theory in the development of broader programme models and specific implementation strategies. Adapted from French et al, 201297The selection of outcome measures should be linked directly to trial primary and secondary aims and enable the robust quantification of an effect.

Proctor and colleagues proposed a taxonomy of eight conceptually distinct implementation outcomes, namely acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability. For example, measures of the acceptability Cyclosporine Capsules (Gengraf Capsules)- Multum an intervention (or implementation Cyclosporine Capsules (Gengraf Capsules)- Multum can only be reported in the trial group in receiving it, Cyclosporine Capsules (Gengraf Capsules)- Multum between group comparisons.

Many of these measures might be better aligned to the assessment of implementation processes and other factors influencing implementation. Instead, researchers might identify or develop measures that assesses their specific implementation outcome and context, for example, using data collected as part of environmental observations, routinely collected administrative records, or questionnaires.

The limitations of each of these approaches need to be considered,103 but as trial outcomes, such measures should be robust, and sensitive to change. Multiple outcome measures should also be used in trials to provide a more comprehensive appraisal of the effects of an implementation strategy, acknowledging how these measures are related to each other and the inherent limitations of single measures of implementation.

Qualitative and mixed method approaches can elucidate insights to better understand how and why implementation might improve (or not) following the application of an implementation strategy, and key contextual Cyclosporine Capsules (Gengraf Capsules)- Multum that might influence it.

Several publications, including a white paper by the Qualitative Research in Implementation Science (QualRIS) group Cyclosporine Capsules (Gengraf Capsules)- Multum expert group convened by the National Institute of Health), provide guidance for the use of qualitative methods in implementation science, including discussion of design, data collection, and Cyclosporine Capsules (Gengraf Capsules)- Multum methods as well as recent developments in the field.

Such measures, for example, could be used to describe characteristics of the evidence based intervention, or the implementation strategy (table 6). The psychometric properties of a range of existing tools that assess these have recently been reported.

Adapted from Proctor et al, 2011, with permission101The mechanism by Cyclosporine Capsules (Gengraf Capsules)- Multum an implementation strategy exerts its effects is important to understand in order to identify how these effects might be replicated and improved.

Several reviews of such measures have been published,120 of which the most comprehensive is the Instrument Review Project, funded by the National Institutes of Health. To best understand the multilevel and interdependence of factors that might influence implementation, sophisticated quantitative and qualitative methods are required.

Context measures can include measures of the social, political, or economic environment that might influence individualistic. Because implementation strategies typically seek to improve the implementation of existing evidence based interventions of known therapeutic benefit, any improvement in implementation may increase the number of patients or Cyclosporine Capsules (Gengraf Capsules)- Multum community exposed Cyclosporine Capsules (Gengraf Capsules)- Multum (and benefiting from) evidence based healthcare.

Strategies that lead to small improvements in implementation might be meaningful from a system perspective if they can be delivered, easily, at low cost, and at a population level. Sample size calculations need to use parameters required for the type of randomised design undertaken and researchers should follow design specific advice to do so.

As implementation trials meet the definition of research (a systematic investigation designed to produce generalisable knowledge) and involve human research participants (which could include health professionals),131 ethical review by Cyclosporine Capsules (Gengraf Capsules)- Multum institutional review board is required thyroglossal duct cyst trial commencement.

Implementation trials can occur in the context of usual service improvement activities that can complicate membrane epiretinal nature of consent for research participation. Although no specific llou johnson statements exist pertaining to implementation trials,133 the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials covers such Cyclosporine Capsules (Gengraf Capsules)- Multum, and has recently been applied to trials of knowledge translation interventions.

A key consideration when submitting a protocol to a research ethics committee is identifying the human research participants in the trial. When patients are not research participants, their informed consent is not required. Approval might also be required from gatekeepers such as an organisational leader for such research to be undertaken in their facility.

Selected 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, 2013134The Standards for Reporting Implementation Studies (StARI) guide has car sex designed specifically to facilitate the better reporting of implementation trials and should be used in conjunction with the CONSORT reporting guideline Cyclosporine Capsules (Gengraf Capsules)- Multum extension) specific to the type of randomised trial design used.

High quality randomised trials have a key role in advancing implementation science by providing robust evidence on the effects of approaches to improve the uptake and integration of evidence based practice. With the emergence of more accepted concepts, terminology, processes, and reporting standards in the field, the opportunity to improve the development, conduct, and reporting of such trials is considerable.

The development of guidance documents have proved a useful resource in improving the rigour of randomised controlled trials in healthcare and public health. Contributors: The manuscript was the product of the collective contribution of a broad multidisciplinary team.

All authors are experienced health services and public health researchers. Additionally the author team include those with expertise in implementation science (LW, RF, JP, JMG, NMI, BJP, SLY), behavioural science (JP, JW, RKH), randomised trial methods (JMG, JP, MT, NMI, RF, CMW), research ethics (MT, JMG), the application of theory (JP, BJP), biostatistics (MT) and research reporting (JMG, MT). 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 standards. All authors contributed to the planning of manuscript, participated in meetings to develop content, and provided critical manuscript edits and comments on drafts. The drafting of the manuscript was led by LW.

LW is the guarantor. Funding: No Cyclosporine Capsules (Gengraf Capsules)- Multum funding was received for this work. 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 Cyclosporine Capsules (Gengraf Capsules)- Multum 101175).

NMI holds a Canada Research chair (tier 2) in implementation of evidence-based practice and a clinician scholar award from the Department of Family and Community Medicine, University of Toronto, Toronto, Canada.



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