Background: Randomized trials may be designed to provide evidence more related to intervention efficacy or effectiveness. When systematic reviews are used to inform clinical or policy decisions, it is important to know the efficacy-effectiveness nature of information from the included trials.
Objective: To develop a tool to characterize randomized trials information 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 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, (4) clinical relevance of interventions. When RITES was piloted on trials from 3 reviews by unaffiliated raters, ratings were variable (Intraclass Correlation Coefficients (ICCs) 0.23-0.45 for the four domains; 0.25-0.66 after excluding outliers), but when used on one review by the review authors with expertise on the topic the ratings were consistent (ICCs >0.80).
Conclusion: RITES may help characterize the efficacy-effectiveness nature of trial information in systematic reviews.
- Comparative Effectiveness Research
- Systematic reviews
- Randomized controlled trials