ASPECT-R—A Tool to Rate the Pragmatic and Explanatory Characteristics of a Clinical Trial Design

Conclusion: This new tool, ASPECT-R, should provide a reliable, objective way to rate studies along the explanatory-pragmatic spectrum that will better support trial design and facilitate interpretation of completed trials. The complete ASPECT-R tool and guide materials can be accessed online by clicking or visiting this link: http://innovationscns.com/aspect-r-tool-and-training-materials/. Introduction Clinical trial designs differ considerably with respect to whether they are conducted under highly controlled and defined conditions (explanatory) or more broadly reflect real world circumstances (pragmatic). These different approaches to trial design are generally aimed at addressing different questions with varying strengths and limitations and differences in extent of generalizability. These differences in trial design may substantially impact results even when similar interventions or treatments are compared. Failure to consider the differences in trial design may lead to misinterpretation of individual studies and when studies are analyzed as a group (as in meta-analyses). Because specific trials are designed on a spectrum of “explanatoriness” or “pragmaticness,” methodologists have begun to develop instruments that facilitate identification of key explanatory and pragmatic elements in clinical trial designs.[1,2] By standardizing the characterization of study designs, they can support researchers, clinicians, healthcare providers, and policymakers in understandin...
Source: Innovations in Clinical Neuroscience - Category: Neuroscience Authors: Tags: Brief Report Current Issue Drug Development Trial Methodology ASPECT-R explanatory pragmatic trial design Source Type: research