Mark C Bicket1, Robert W Hurley, Jee Youn Moon, Chad M Brummett, Steve Hanling, Marc A Huntoon, Jan van Zundert, Steven P Cohen. 1. 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.
Abstract
BACKGROUND AND OBJECTIVES: 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.
BACKGROUND AND OBJECTIVES: 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: Robert W Hurley; Meredith C B Adams; Meredith Barad; Arun Bhaskar; Anuj Bhatia; Andrea Chadwick; Timothy R Deer; Jennifer Hah; W Michael Hooten; Narayan R Kissoon; David Wonhee Lee; Zachary Mccormick; Jee Youn Moon; Samer Narouze; David A Provenzano; Byron J Schneider; Maarten van Eerd; Jan Van Zundert; Mark S Wallace; Sara M Wilson; Zirong Zhao; Steven P Cohen Journal: Pain Med Date: 2021-11-26 Impact factor: 3.750
Authors: Robert W Hurley; Meredith C B Adams; Meredith Barad; Arun Bhaskar; Anuj Bhatia; Andrea Chadwick; Timothy R Deer; Jennifer Hah; W Michael Hooten; Narayan R Kissoon; David Wonhee Lee; Zachary Mccormick; Jee Youn Moon; Samer Narouze; David A Provenzano; Byron J Schneider; Maarten van Eerd; Jan Van Zundert; Mark S Wallace; Sara M Wilson; Zirong Zhao; Steven P Cohen Journal: Reg Anesth Pain Med Date: 2021-11-11 Impact factor: 6.288
Authors: Steven P Cohen; Arun Bhaskar; Anuj Bhatia; Asokumar Buvanendran; Tim Deer; Shuchita Garg; W Michael Hooten; Robert W Hurley; David J Kennedy; Brian C McLean; Jee Youn Moon; Samer Narouze; Sanjog Pangarkar; David Anthony Provenzano; Richard Rauck; B Todd Sitzman; Matthew Smuck; Jan van Zundert; Kevin Vorenkamp; Mark S Wallace; Zirong Zhao Journal: Reg Anesth Pain Med Date: 2020-04-03 Impact factor: 6.288
Authors: Crystian B Oliveira; Christopher G Maher; Manuela L Ferreira; Mark J Hancock; Vinicius Cunha Oliveira; Andrew J McLachlan; Bart W Koes; Paulo H Ferreira; Steven P Cohen; Rafael Zambelli Pinto Journal: Cochrane Database Syst Rev Date: 2020-04-09