Wieland, LS and Berman, BM and Altman, DG and Barth, J and Bouter, LM and Adamo, CRD and Linde, K and Moher, D and Mullins, CD and Treweek, S and Tunis, S and Windt, DAVD and Zwarenstein, M and Witt, C (2017) Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES): development of a new tool for systematic reviews. Journal of Clinical Epidemiology. -. ISSN 0895-4356

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Abstract

AbstractBackground 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.

Item Type: Article
Uncontrolled Keywords: Comparative Effectiveness Research; Systematic reviews; Randomized controlled trials; Pragmatic trial; Explanatory trial; Effectiveness; Efficacy; Applicability
Subjects: R Medicine > RA Public aspects of medicine
Divisions: Faculty of Medicine and Health Sciences > Primary Care Health Sciences
Depositing User: Symplectic
Date Deposited: 23 Mar 2017 09:16
Last Modified: 23 Mar 2017 09:16
URI: http://eprints.keele.ac.uk/id/eprint/3049

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