1980 LOW METHODOLOGICAL AND REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS FOR DEVICES TO TREAT UROLITHIASIS

Abstract

You have accessJournal of UrologyStone Disease: SWL, Ureteroscopy or Percutaneous Stone Removal (IV)1 Apr 20131980 LOW METHODOLOGICAL AND REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS FOR DEVICES TO TREAT UROLITHIASIS Peter Zavitsanos, Vincent G. Bird, Kathryn Mince, Molly M. Neuberger, and Philipp Dahm Peter ZavitsanosPeter Zavitsanos Gainesville, FL More articles by this author , Vincent G. BirdVincent G. Bird Gainesville, FL More articles by this author , Kathryn MinceKathryn Mince Gainesville, FL More articles by this author , Molly M. NeubergerMolly M. Neuberger Gainesville, FL More articles by this author , and Philipp DahmPhilipp Dahm Gainesville, FL More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2399AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Urological devices are integral to the endourological armamentarium for treating stone disease and are increasingly being investigated in randomized controlled trials (RCTs) with the promise of yielding high quality evidence on comparative effectiveness. We performed a systematic review to assess the methodological and reporting quality of RCTs evaluating the management of stone disease. METHODS We performed a protocol-driven systematic literature search in PubMed for published RCTs from 2002-2011 that included a surgical device in at least one arm of the trial. We developed and pilot-tested a standardized data extraction form based on the CONsolidated Standards of Reporting Trials (CONSORT) criteria as well as clinical variables relevant to stone disease. The CONSORT criteria summary score was calculated on a scale of 0 to 25. Statistical hypothesis testing was performed using SPSS 20.0 with a two-sided alpha of 0.05 to assess whether overall reporting had changed between 2002-2006 and 2007-2011. RESULTS One hundred four RCTs with a mean sample size of 107 patients (range of 18 to 903) met inclusion criteria. The most commonly studied device-related procedures were percutaneous nephrolithotripsy (44.4%), ureteral stents (28.5%) and shockwave lithotripsy (25.0%). The most prevalent continents producing studies were Asia (37.5%), Europe (32.7%) and North America (19.2%). The mean (± standard error of the mean) CONSORT summary scores were 11.4 ± 0.4 and 12.1 ± 0.3 in 2002-2006 and 2007-2011, respectively, with a mean difference of 0.7 (95% confidence interval −0.3 to 1.6; p=0.167). Information concerning prior stone treatment (28.2% versus 32.3%), re-treatment after procedure (53.8% versus 56.9%), and a definition of stone-free status (33.3% versus 40%) was provided in studies from 2002-2006 and 2007-2011, respectively. CONCLUSIONS While the number of RCTs investigating the use of urological devices to treat stone disease has substantially increased over time, methodological and clinical reporting quality remains sub-optimal, thereby compromising these studies' credibility. Increased efforts among investigators, reviewers and journal editors to promote the appropriate conduct and reporting of RCTs in endourology are therefore warranted. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e812-e813 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Peter Zavitsanos Gainesville, FL More articles by this author Vincent G. Bird Gainesville, FL More articles by this author Kathryn Mince Gainesville, FL More articles by this author Molly M. Neuberger Gainesville, FL More articles by this author Philipp Dahm Gainesville, FL More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...