As we have explored relevant work in the VA and the implementation field in general, we have seen nonsystematic efforts at blending effectiveness and implementation trial elements. Through this hybrid framework we offer guidance to the field and hopefully provide assistance to investigators searching for identifiable design solutions. In addition, we hope to stimulate further thinking and to encourage new design combinations. The hybrid definition and typology offered here must be considered constructs still in evolution. It is important to note that the “boundaries” we have drawn around these hybrid types are not intended to be rigid, and that future work should refine and extend what has been presented here. In addition, we recognize that some of the “recommended conditions for use” of the hybrids are subjective (eg, current definitions of “strong face validity” and “indirect evidence”) and that they will need to be reasoned and argued by investigators on a case-by-case basis at least until additional work refines the definitions and conditions.
Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice. However, despite their potential benefits, we recommend that certain conditions should first be met; and, even when desirable, we recognize that hybrids might not always be feasible or affordable within traditional research budget limits. We recommend that future hybrid research seeks to document in both quantitative and qualitative ways the extent and manner in which translation has been sped. As of now, we can only say that these hybrids have the potential to speed and improve translation. Further, the relative speed of translation is not usually included in traditional cost effectiveness analyses, and it would be interesting to explore the potential benefits of hybrid designs from this perspective.
In considering use of a hybrid, it is important to acknowledge the potential “ecological” challenges associated with pursuing such designs. First, researchers from clinical and implementation research backgrounds often do not share concepts, constructs, and vocabulary; more difficult, sometimes the vocabulary is the same but the meanings are different. This makes it somewhat difficult for researchers from different traditions to communicate efficiently and effectively, which could serve as a barrier to collaboration, and perhaps also impede comprehension during research proposal and manuscript reviews. More specifically, lack of reviewer expertise on grant review panels and among journal reviewers and editorial boards relative to emerging concepts and innovations in the field of implementation science can have an inhibitory effect on the development, implementation, and reporting of hybrid studies. Review of hybrid designs requires at least an appreciation of the complexities balancing internal and external validity considerations in such trials, as well as the design trade-offs inherent in structuring such complex protocols and related budgetary needs. Reviews must also, of course, have sufficient technical expertise across members so that, in aggregate, both the clinical intervention and the implementation aspects of the study can be effectively evaluated.
Finally, the same appreciation and expertise required of journal and grant review bodies is required on promotion and tenure committees, although as implementation research and hybrid designs become more widely appreciated, this lack of expertise will diminish—as it has for effectiveness-oriented clinical trials.4,38–40
Hybrid studies are typically more complex to execute and thus may be relatively “high risk”; however, the successfully implemented hybrid study will likely pay dividends across both the (a priori) clinical and implementation foci, thus yielding rich data that will be of use both scientifically and in terms of public health impact.
The impetus to blend or explicitly link research traditions in the service of accelerating scientific progress and enhancing public health impact is not at all new,4,38–40
and the idea of blending clinical effectiveness and implementation research elements is also not new. As the examples above indicate, “informal” hybrid design trials are already being conducted and reported. The function of this study is both to help the field better organize its thinking and design deliberations concerning these concepts that we felt were not yet clearly articulated and to stimulate further development. The “ecological” challenges noted above will not endure. They can be overcome, like many diffusion of innovation challenges, with education and committed leadership over time.