The preferred methodologies to use in a translational phase are also unclear. Translational studies tend to use a pre-post evaluative framework and focus on replicating positive outcomes from the original efficacy or effectiveness trials. Nevertheless, as noted above, there is no consensus as to what constitutes the specific activities as well as testing strategies that should be included in this phase, and this in turn has hindered an understanding of how a translational phase supports implementation (Gitlin et al., 2015). As suggested above, it may be helpful to consider translational activities, if necessary, as a pilot for a large-scale implementation study. Alternately, some study designs at the efficacy phase may enable investigators to avoid translational activities. For example, using a pragmatic trial study design (see Table 2.2 for its definition) in which an intervention is tested within the context in which it will ultimately be implemented may avoid the necessity of translation.
Thus, a translational study may serve as a pilot for a full-blown implementation study. An implementation study has multiple purposes, such as: evaluating different strategies for implementing an intervention; testing and standardizing mechanisms regarding how to identify the targeted populations and evaluate the feasibility of proposed referral and enrollment procedures; evaluating training approaches for interventionists; and identifying strategies to maintain fidelity. As for the latter, determining ways to monitor the quality of and the fidelity in delivery of the intervention is a primary focus of any translation and implementation study. The challenges of fidelity monitoring in this phase is doing so in real-world settings (see Chapter 12 for further discussion of this point).
Similar to the phases and pilot testing that need to occur prior to conducting an efficacy trial, there are various stages to implementation studies as well. Fixsen and colleagues identify these stages as exploration, installation, initial implementation, full implementation, innovation, and sustainability (Fixsen, Naoom, Blase, Friedman, & Wallace, 2005). However, there are no clear directives as to how to proceed with implementation testing. Furthermore, as discussed earlier, hybrid designs that combine effectiveness with implementation of scientific questions, or use of pragmatic trials, may provide an understanding of implementation such that a phase devoted to testing implementation approaches may not be necessary in all cases.