Inter-rater Reliability Assessment of ASPECT-R (A Study Pragmatic-Explanatory Characterization Tool-Rating)

Conclusion: The inter-rater reliability of the ASPECT-R total score was excellent, with excellent to good inter-rater reliability for most domains. The fair to poor inter-rater reliability for two domains may reflect a need for improved domain definition, anchoring, or training materials. ASPECT-R can be used to help understand the pragmatic-explanatory nature of completed or planned trials. Introduction Clinical trials have characteristics that are pragmatic (i.e., effectiveness studies asking whether an intervention works under usual or real-world conditions) and/or explanatory (i.e., asks whether an intervention works under highly controlled and well-defined conditions). Trials utilizing either or both of these types of characteristics have value, with neither being intrinsically superior to the other. However, the increasing importance of real world data for clinical and policy decision making is driving a need for close attention to the pragmatic-explanatory characteristics or continuum of the study design. The ASPECT-R (A Study Pragmatic-Explanatory Characterization Tool-Rating; ©2014 Janssen Pharmaceuticals, Inc.) is an instrument informed from the PRECIS (Pragmatic-Explanatory Continuum Indicator Summary) tool described previously by Thorpe et al.[1] The PRECIS, with its 10 domains assessing study design on an unmarked visual analog scale, was developed to assist researchers when designing trials along the explanatory:pragmatic spectrum.[1] Tosh et al[2] adapted the ...
Source: Innovations in Clinical Neuroscience - Category: Neuroscience Authors: Tags: Current Issue Drug Development Original Research Trial Methodology ASPECT-R explanatory Inter-rater reliability Intraclass correlation coefficient pragmatic real-world trial design Source Type: research