Balancing Internal and External Validity Using Precis-2 and Re-Aim: Case Exemplars.

The National Institutes of Health estimated that $3-$4 billion is spent supporting clinical trials annually, yet an average of 17 years is required for research evidence to be implemented into practice. Study designs that balance external and internal validity, based on the goals of the study and relative to the state of the science, may accelerate knowledge translation. The purpose of this case study was to evaluate two randomized control trials on the effectiveness-efficacy continuum using the PRagmatic Explanatory Continuum Indicator Summary and the Research Effectiveness Adoption Implementation Maintenance model. Findings provided insight into strategies that may lead to more balanced approaches to research design. Incorporating tools such as PRECIS-2 and RE-AIM when designing and implementing research interventions may accelerate knowledge translation to close the gap between scientific knowledge and clinical practice.