Clinical Epidemiology: The Essentials
- RH Fletcher, SW Fletcher, GS. Fletcher
I t has been proposed that the clinical translational research paradigm should be adapted to simulation research when describing how learning with simulation impacts patient outcomes.1Y3 Harmonizing terminology between translational and simulation research can be an important step toward that goal. Stedman’s Medical Dictionary defines effectiveness as ‘‘A measure of the accuracy or success of a diagnostic or therapeutic technique when carried out in an average clinical environment’’ and efficacy as ‘‘The extent to which a specific intervention, procedure, regimen or service produces a beneficial result under ideal conditions’’ (italics added for emphasis). The definitions of efficacy trials (Does the intervention work under ideal conditions such as patients who cooperate fully?) versus effectiveness trials (Does the intervention help under ordinary conditions such as patients being allowed to accept or reject it as they might ordinarily do?) are consistent with the medical dictionary definitions. In general, the clinical and translational science literature selectively uses the words efficacious/efficacy and effective/ effectiveness consistent with their medical definitions to differentiate between an intervention (such as a drug) that can work in a controlled patient population during a randomized controlled trial and one that works in the real world in dayto-day practice, respectively. When reviewing the simulation in healthcare literature for outcomes studies, the word effective is generally used in a different way from its definition in clinical translational research. For simulation researchers with less exposure to translational research, the subtle but important distinction between the words efficacious and effective may not be apparent. In fact, in a recent review of 109 journal articles where simulation was used as an educational intervention, the words effective or effectiveness appear 38 times (including in the title), whereas the word efficacy appears once, and the word efficacious is nonexistent. In another review of simulation-based medical education research, the words efficacy and efficacious never appear. A notable exception is an editorial by Gaba, where efficacy, not effectiveness, was used when referring to a simulation’s impact on patient outcomes. We believe that more judicious use of such terms as efficacious and effective in the simulation in healthcare literature can reinforce that simulation is not an end in itself but a means to an end, that is, improved patient outcomes. Studies where simulation has been proven to be efficacious, let alone effective, by the clinical and translational science definitions respective to patient outcomes are the rare exception. Discussion of ‘‘phased’’ simulation trial is nearly nonexistent. In fact, we are not aware of any study that has demonstrated the effectiveness of any specific simulation-based intervention in terms of patient outcomes at multicenter, nationwide, or global scales. As simulation researchers, we may need to accept that, for some patient outcomes studies, the best we can strive for is to prove efficacy of a simulation-based intervention and that proving effectiveness is beyond what is currently possible in translational research. The preponderant use of the word effective in the simulation in healthcare literature may be based on its more common use in lay language compared with, and possibly its quasi-synonymous lay meaning to, efficacious. Common definitions for the terms effective and efficacious are ‘‘having a definite or desired effect’’ and ‘‘producing or sure to produce the desired effect,’’ respectively, and do not explicitly consider the studied population. The simulation in healthcare community is a young discipline and, as such, can be expected to lack precision in basic terminology. Yet, it is this precision in language that facilitates effective communication of thought within a field. Manuscript and proposal reviewers may find it confusing if the simulation in healthcare community continues to use the term effective contrary to its established definition in medicine and translational science. We propose that manuscripts in translational simulation research should adopt the use of the words efficacious and effective consistent with their medical and translational research definitions. To some, exercises in nomenclature and terminology may seem pedantic, but we believe that these discussions can facilitate dialogue and collaboration between the clinical, translational, and educational research communities and cultures.