title: Rating of Included Trials on the Efficacy-Effectiveness Spectrum: development of a new tool for systematic reviews.
abstract: 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.
  
  
  CONCLUSIONS
  RITES may help to characterize the efficacy-effectiveness nature of trials included in systematic reviews.
authors.affiliation: Center for Integrative Medicine, University of Maryland School of Medicine, 520 West Lombard Street, East Hall, Baltimore, MD, 21201, USA. Electronic address: swieland@som.umaryland.edu.
authors.forename: L Susan
authors.initials: LS
authors.lastname: Wieland
authors.affiliation: Center for Integrative Medicine, University of Maryland School of Medicine, 520 West Lombard Street, East Hall, Baltimore, MD, 21201, USA.
authors.forename: Brian M
authors.initials: BM
authors.lastname: Berman
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, Windmill Road, University of Oxford, Oxford, OX3 7LD, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zürich, Rämistrasse 100, Zürich CH-8091, Switzerland.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Barth
authors.affiliation: Department of Epidemiology & Biostatistics, VU University Medical Center, PO Box 7057, Amsterdam, 1007 MB, The Netherlands; Department of Philosophy, Faculty of Humanities, Vrije Universiteit, De Boelelaan 1105, Amsterdam 1081 HV, The Netherlands.
authors.forename: Lex M
authors.initials: LM
authors.lastname: Bouter
authors.affiliation: Center for Integrative Medicine, University of Maryland School of Medicine, 520 West Lombard Street, East Hall, Baltimore, MD, 21201, USA.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: D'Adamo
authors.affiliation: Institute of General Practice, University Hospital rechts der Isar, Technical University Munich, Orleansstrasse 47, Munich 81667, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Linde
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, 725 Parkdale Avenue, Ottawa, ON K1Y 4E9, Canada; School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, 451 Smyth Road, Ottawa ON K1H 8M5, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Moher
authors.affiliation: Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, 20 North Pine Street, Baltimore, MD 21201, USA.
authors.forename: C Daniel
authors.initials: CD
authors.lastname: Mullins
authors.affiliation: Health Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK.
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
authors.affiliation: Center for Medical Technology Policy, World Trade Center Institute, 401 E Pratt St # 631, Baltimore, MD 21202, USA.
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
authors.affiliation: Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Primary Care Sciences, Keele University, Staffordshire ST5 5BG, UK.
authors.forename: Danielle A
authors.initials: DA
authors.lastname: van der Windt
authors.affiliation: Centre for Studies in Family Medicine, Schulich School of Medicine & Dentistry, Western University, Western Centre for Public Health and Family Medicine, 1151 Richmond Street, London, ON, N6A 3K7, Canada.
authors.forename: Merrick
authors.initials: M
authors.lastname: Zwarenstein
authors.affiliation: Center for Integrative Medicine, University of Maryland School of Medicine, 520 West Lombard Street, East Hall, Baltimore, MD, 21201, USA; Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zürich, Rämistrasse 100, Zürich CH-8091, Switzerland; Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Luisenstr. 57, Berlin 10117, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Witt
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods* / Q000706:statistics & numerical data*; D003697:Delphi Technique; D015340:Epidemiologic Research Design; D005240:Feasibility Studies; D006801:Humans; D015588:Observer Variation; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012196:Review Literature as Topic; D016896:Treatment Outcome
keywords: Applicability; Comparative effectiveness research; Effectiveness; Efficacy; Explanatory trial; Pragmatic trial; Randomized controlled trials; Systematic reviews