title: The Development and Validation of a Quality Assessment and Rating of Technique for Injections of the Spine (AQUARIUS).
abstract: OBJECTIVE
  Systematic reviews evaluate the utility of procedural interventions of the spine, including epidural steroid injections (ESIs). However, existing quality assessment tools either fail to account for proper technical quality and patient selection or are not validated. We developed and validated a simple scale for ESIs to provide a quality assessment and rating of technique for injections of the spine (AQUARIUS).
  
  
  METHODS
  Seven experts generated items iteratively based on prior ESI technique studies and professional judgment. Following testing for face and content validity, a 17-item instrument was used by 8 raters from 2 different backgrounds to assess 12 randomized controlled trials, selected from 3 different categories. Using frequency of assessment, a 12-item instrument was also generated. Both instruments underwent reliability (intraclass correlation coefficient), validity (ability to distinguish "low," "random," and "high" study categories), and diagnostic accuracy (receiver operating characteristics) testing.
  
  
  RESULTS
  Both 17- and 12-item instruments were scored consistently by raters regardless of background, with overall intraclass correlation coefficients of 0.72 (95% confidence interval [CI], 0.53-0.89) and 0.71 (95% CI, 0.51-0.89), respectively. Both instruments discriminated between clinical trials from all 3 categories. Diagnostic accuracy was similar for the 2 instruments, with areas under receiver operating characteristic curves of 0.89 (95% CI, 0.82-0.96) and 0.90 (95% CI, 0.82-0.97), respectively.
  
  
  CONCLUSIONS
  The instrument in both 17- and 12-item formats demonstrates good reliability and diagnostic accuracy in rating ESI studies. As a complement to other tools that assess bias, the instrument may improve the ability to evaluate evidence for systematic reviews and improve clinical trial design.
authors.affiliation: From the *Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; †Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI; ‡Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea; §Division of Pain Medicine, Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI; ∥Pain Medicine Division, Department of Anesthesiology, Naval Medical Center-San Diego, CA; ¶Department of Anesthesiology, Vanderbilt University School of Medicine, Nashville, TN; #Department of Anaesthesiology and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium; **Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Bicket
authors.forename: Robert W
authors.initials: RW
authors.lastname: Hurley
authors.forename: Jee Youn
authors.initials: JY
authors.lastname: Moon
authors.forename: Chad M
authors.initials: CM
authors.lastname: Brummett
authors.forename: Steve
authors.initials: S
authors.lastname: Hanling
authors.forename: Marc A
authors.initials: MA
authors.lastname: Huntoon
authors.forename: Jan
authors.initials: J
authors.lastname: van Zundert
authors.forename: Steven P
authors.initials: SP
authors.lastname: Cohen
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D006801:Humans; D007278:Injections, Spinal / Q000592:standards* / Q000639:trends*; D011785:Quality Assurance, Health Care / Q000592:standards* / Q000639:trends*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires / Q000592:standards*