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BACKGROUND: Randomized trials may be designed to provide evidence more strongly related to efficacy or effectiveness of an intervention. When systematic reviews are used to inform clinical or policy decisions, it is important to know the efficacy-effectiveness nature of the included trials. OBJECTIVE: To develop a tool to characterize randomized trials included in a systematic review on an efficacy-effectiveness continuum. METHODS: We extracted rating domains and descriptors from existing tools, and used a modified Delphi procedure to condense the domains and develop a new tool. The feasibility and inter-rater reliability of the tool was tested on trials from 4 systematic reviews. RESULTS: The RITES (Rating of Included Trials on the Efficacy-effectiveness Spectrum) tool rates clinical trials on a 5-point Likert scale in four domains: (1) participant characteristics, (2) trial setting, (3) flexibility of interventions, and (4) clinical relevance of interventions. When RITES was piloted on trials from 3 reviews by unaffiliated raters, ratings were variable (Intraclass Correlation Coefficient 0.25-0.66 for the four domains), but when RITES was used on 1 review by the review authors with expertise on the topic the ratings were consistent (ICCs >0.80. CONCLUSION: RITES may help to characterize the efficacy-effectiveness nature of trials included in systematic reviews.

Original publication

DOI

10.1016/j.jclinepi.2017.01.010

Type

Journal article

Journal

Journal of Clinical Epidemiology

Publisher

Elsevier

Publication Date

07/02/2017

Keywords

Applicability, Comparative Effectiveness Research, Effectiveness, Efficacy, Explanatory trial, Pragmatic trial, Randomized controlled trials, Systematic reviews