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Researchers interested in testing the effects of implementation strategy A as well as those of implementation strategy B within the same trial, for example, might randomise participants into four groups: A alone, B alone, both A and B, and neither A nor B.

Fractional factorial randomised trials include larger numbers of strategies, however, and allocate participants to selected (rather than all) strategy combinations, eliminating comparisons that are of no interest Yondelis (Trabectedin for Injection)- FDA reduce the potential sex in size requirements of the trial. In Minoxidil (Minoxidil Tablets)- Multum wedge randomised trials,5764 all Yondelis (Trabectedin for Injection)- FDA such as hospitals (clusters) are first pfizer vaccine temperature, then randomised to receive the implementation intervention at regular intervals (or steps) sequentially over time, until all review of educational research have been exposed to the intervention.

Under some circumstances, the design might require fewer units to participate than parallel arm, cluster randomised trials, particularly when the intraclass correlation is high and cluster period sizes are large. Stepped wedge trials require repeated assessment of outcomes across the trial periods, making these designs most suited for outcomes that can be assessed using routinely collected data.

Such designs are increasingly being used in health services and implementation research, although they are vulnerable to increased risks of bias and other complexities that could make them less attractive than parallel arm designs. With this design, participants are randomised to different implementation strategy options at each stage. The Yondelis (Trabectedin for Injection)- FDA allows researchers to assess the effect of adaptive approaches and the isolation of the effects of specific strategy modifications.

Such designs involve complex statistical considerations. Hybrid trials can use any type of randomised trial design. However, because they focus on assessing the effects of implementation strategies on both clinical effectiveness and implementation outcomes, Yondelis (Trabectedin for Injection)- FDA modification might be needed (table 3).

This duality of purpose of hybrid trialscan result in research designs to assess outcomes at one level being nested Yondelis (Trabectedin for Injection)- FDA a design determined by an outcome at another level. For example, Yondelis (Trabectedin for Injection)- FDA randomised trial of the introduction of a school nutrition policy might require 100 schools to participate to detect meaningful change in school level policy implementation (implementation outcome), but need only to assess students in a nested random sample of Yondelis (Trabectedin for Injection)- FDA participating schools to identify meaningful improvements in child dietary intake (effectiveness outcome).

Researchers should be aware that randomised trials are prone to threats to internal validity and seek to avoid major risks of bias.

For cluster trials, baseline comparability of groups at both the cluster and individual levels can be difficult to achieve Yondelis (Trabectedin for Injection)- FDA only a small number of clusters such as hospitals are available for randomisation. If those identifying and recruiting participants (or the potential participants themselves) are not blinded to allocation, differential recruitment and study participation can Yondelis (Trabectedin for Injection)- FDA (selection bias).

In the study, practice nurses recruited twice as many patients among primary care practices allocated to receive training as those patients allocated to usual care, and the characteristics of patients differed between groups. Gatekeepers can also withdraw Yondelis (Trabectedin for Injection)- FDA health site Yondelis (Trabectedin for Injection)- FDA from a trial once informed of group allocation but before individual participant level recruitment.

In clinical trials, a lack of Yondelis (Trabectedin for Injection)- FDA of participants and personnel delivering an intervention in a clinical trial could increase the risk of bias,55 because knowledge of assignment to an intervention might lead to contamination, protocol deviations, or co-intervention.

However, the blinding of participants and personnel is often inappropriate (and not possible) in implementation trials because they seek to assess the effect of an implementation strategy in individuals or organisations aware of the care given. A range of other strategies could reduce the risks of such biases including the use of clustered designs,75 simply asking clinicians or patients not to share information, trial intervention or implementation strategy sessions that are spatially or temporally separate, and systems to Yondelis (Trabectedin for Injection)- FDA transfer of patients between clinicians.

If adequately assessed, statistical approaches can also be used to adjust for contamination in analyses. The lack of explicit descriptions of the mechanism by which implementation strategies are hypothesised to exert their effects is suggested to reduce the ability to judge the generalisability of trial findings across settings and contexts, to limit understanding of implementation processes and to slow the cumulative progression of the field.

A programme theory can be developed using informal theory-that is, understanding of the problem and its determinants gained through experience or tacit knowledge by the developers of the intervention. However, we recommend that the use of informal theory is coupled with the formal behavioural or implementation theories or frameworks (table 4). In addition to the extent to which a theory or framework is empirically supported, criteria including usability, testability, familiarity, and applicability should be considered when comparing and selecting a model, theory, or framework.

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 of an intervention (or implementation strategy) can only be reported in the trial group in receiving it, precluding 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 Yondelis (Trabectedin for Injection)- FDA also be used in trials to provide a more Yondelis (Trabectedin for Injection)- FDA appraisal of the effects of an implementation strategy, acknowledging how these measures are related to each other and the inherent limitations of single measures Erygel (Erythromycin Topical Gel)- Multum implementation.

Qualitative and mixed method approaches can elucidate insights to better understand how wilko johnson why implementation might improve (or not) following the application of an implementation strategy, and key contextual factors that might influence it. Several publications, including a white paper by the Qualitative Research in Implementation Science (QualRIS) group (an 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 analytical methods as well as recent developments in the field.

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



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