Rating of Included Trials on the Efficacy–Effectiveness Spectrum: development of a new tool for systematic reviews

L. Susan Wieland, Brian M. Berman, Douglas G. Altman, Jürgen Barth, Lex M. Bouter, Christopher R. D'Adamo, Klaus Linde, David Moher, C. Daniel Mullins, Shaun Treweek, Sean Tunis, Danielle A. van der Windt, Merrick Zwarenstein, Claudia Witt

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background and Objective 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. The objective of this study was 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 interrater reliability of the tool was tested on trials from four systematic reviews. Results The Rating of Included Trials on the Efficacy–Effectiveness Spectrum (RITES) tool rates clinical trials on a five-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 three reviews by unaffiliated raters, ratings were variable (intraclass correlation coefficient [ICC] 0.25–0.66 for the four domains); but, when RITES was used on one 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 languageEnglish
Pages (from-to)95-104
Number of pages10
JournalJournal of Clinical Epidemiology
Volume84
DOIs
Publication statusPublished - 1 Apr 2017

Cite this

Wieland, L. Susan ; Berman, Brian M. ; Altman, Douglas G. ; Barth, Jürgen ; Bouter, Lex M. ; D'Adamo, Christopher R. ; Linde, Klaus ; Moher, David ; Mullins, C. Daniel ; Treweek, Shaun ; Tunis, Sean ; van der Windt, Danielle A. ; Zwarenstein, Merrick ; Witt, Claudia. / Rating of Included Trials on the Efficacy–Effectiveness Spectrum : development of a new tool for systematic reviews. In: Journal of Clinical Epidemiology. 2017 ; Vol. 84. pp. 95-104.
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title = "Rating of Included Trials on the Efficacy–Effectiveness Spectrum: development of a new tool for systematic reviews",
abstract = "Background and Objective 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. The objective of this study was 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 interrater reliability of the tool was tested on trials from four systematic reviews. Results The Rating of Included Trials on the Efficacy–Effectiveness Spectrum (RITES) tool rates clinical trials on a five-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 three reviews by unaffiliated raters, ratings were variable (intraclass correlation coefficient [ICC] 0.25–0.66 for the four domains); but, when RITES was used on one 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.",
keywords = "Applicability, Comparative effectiveness research, Effectiveness, Efficacy, Explanatory trial, Pragmatic trial, Randomized controlled trials, Systematic reviews",
author = "Wieland, {L. Susan} and Berman, {Brian M.} and Altman, {Douglas G.} and J{\"u}rgen Barth and Bouter, {Lex M.} and D'Adamo, {Christopher R.} and Klaus Linde and David Moher and Mullins, {C. Daniel} and Shaun Treweek and Sean Tunis and {van der Windt}, {Danielle A.} and Merrick Zwarenstein and Claudia Witt",
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Wieland, LS, Berman, BM, Altman, DG, Barth, J, Bouter, LM, D'Adamo, CR, Linde, K, Moher, D, Mullins, CD, Treweek, S, Tunis, S, van der Windt, DA, Zwarenstein, M & Witt, C 2017, 'Rating of Included Trials on the Efficacy–Effectiveness Spectrum: development of a new tool for systematic reviews' Journal of Clinical Epidemiology, vol. 84, pp. 95-104. https://doi.org/10.1016/j.jclinepi.2017.01.010

Rating of Included Trials on the Efficacy–Effectiveness Spectrum : development of a new tool for systematic reviews. / Wieland, L. Susan; Berman, Brian M.; Altman, Douglas G.; Barth, Jürgen; Bouter, Lex M.; D'Adamo, Christopher R.; Linde, Klaus; Moher, David; Mullins, C. Daniel; Treweek, Shaun; Tunis, Sean; van der Windt, Danielle A.; Zwarenstein, Merrick; Witt, Claudia.

In: Journal of Clinical Epidemiology, Vol. 84, 01.04.2017, p. 95-104.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - Rating of Included Trials on the Efficacy–Effectiveness Spectrum

T2 - development of a new tool for systematic reviews

AU - Wieland, L. Susan

AU - Berman, Brian M.

AU - Altman, Douglas G.

AU - Barth, Jürgen

AU - Bouter, Lex M.

AU - D'Adamo, Christopher R.

AU - Linde, Klaus

AU - Moher, David

AU - Mullins, C. Daniel

AU - Treweek, Shaun

AU - Tunis, Sean

AU - van der Windt, Danielle A.

AU - Zwarenstein, Merrick

AU - Witt, Claudia

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Y1 - 2017/4/1

N2 - Background and Objective 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. The objective of this study was 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 interrater reliability of the tool was tested on trials from four systematic reviews. Results The Rating of Included Trials on the Efficacy–Effectiveness Spectrum (RITES) tool rates clinical trials on a five-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 three reviews by unaffiliated raters, ratings were variable (intraclass correlation coefficient [ICC] 0.25–0.66 for the four domains); but, when RITES was used on one 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.

AB - Background and Objective 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. The objective of this study was 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 interrater reliability of the tool was tested on trials from four systematic reviews. Results The Rating of Included Trials on the Efficacy–Effectiveness Spectrum (RITES) tool rates clinical trials on a five-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 three reviews by unaffiliated raters, ratings were variable (intraclass correlation coefficient [ICC] 0.25–0.66 for the four domains); but, when RITES was used on one 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.

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