RE-AIM: Researchers

RE-AIM Framework: Efficacy/Effectiveness
of Health Behavior Interventions

Definition: The impact of an intervention on important outcomes, including potential negative effects, quality of life, and economic outcomes.

Research Issue:

Is efficacy important? Do we have information on negative or unintended consequences of our interventions?

Determining the efficacy or effectiveness of a given intervention is critically important because if an intervention is not minimally efficacious or effective, at the very least, then the issue of evaluating the reach of the intervention becomes moot. Within the RE-AIM framework, efficacy or effectiveness is measured at the level of the individual and is reflective of the success of an intervention when implemented as per intervention guidelines under optimal conditions or in real-world situations, respectively.

When reporting on efficacy or effectiveness, it is also important to document the possible negative or unintended consequences of the intervention on quality of life and related factors. Unfortunately, recent reviews of the literature consistently indicate that few studies evaluate potential negative or iatrogenic impacts of intervention.

The efficacy or effectiveness of an intervention can be determined using experimental or quasi-experimental methods. The critical factor that is necessary is a method that can be used to determine a change of behavior (or maintenance in already active individuals) as a result of the intervention. As such, tests of efficacy or effectiveness can be conducted using prospective study designs with comparison groups or pre-post testing (although the strength of conclusions varies with the scientific rigor of the test).

The determination of efficacy or effectiveness of an intervention is often completed by examining the effect size associated with a given intervention and specified outcomes (e.g., physical activity adherence, health-related quality of life).

Example of Efficacy/Effectiveness from recent literature:

Project GRAD (Graduate Ready for Activity Daily; Zabinski, Calfas, Gehrman, Wilfley, & Sallis, 2001). Project GRAD was an efficacy trial of a physical activity promotion course offered to university students. The results of the trial revealed that the intervention was successful in increasing total energy expenditure, strength exercises, and flexibility exercises of female students. Unfortunately, there were also some unintended negative consequences for women who participated. Female participants who participated in the intervention showed a significant increase in drive for thinness as measured by the Eating Disorder Inventory. This increase was not observed in females in the control condition. These findings suggest that there is a need to assess both positive and potential negative outcomes associated with physical activity trials. By doing so, determining whether an intervention does more good than harm can be assessed in a comprehensive manner. Incidentally, in project GRAD, the mean score for drive for thinness of females in the experimental condition, although statistically significant, was still in the normal range when compared to normative data. As a result, the trial may be considered to have done more good than harm.