TY - JOUR
T1 - Rating of Included Trials on the Efficacy–Effectiveness Spectrum: 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
PY - 2017/4
Y1 - 2017/4
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.
KW - Applicability
KW - Comparative effectiveness research
KW - Effectiveness
KW - Efficacy
KW - Explanatory trial
KW - Pragmatic trial
KW - Randomized controlled trials
KW - Systematic reviews
UR - http://www.scopus.com/inward/record.url?scp=85016498254&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85016498254&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2017.01.010
DO - 10.1016/j.jclinepi.2017.01.010
M3 - Article
C2 - 28188898
AN - SCOPUS:85016498254
SN - 0895-4356
VL - 84
SP - 95
EP - 104
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -
