title: Low methodological and reporting quality of randomized, controlled trials of devices to treat urolithiasis.
abstract: OBJECTIVE
  We assessed the methodological and reporting quality of randomized, controlled trials of stone disease management and determined whether the reporting quality of randomized, controlled trials improved with time.
  
  
  METHODS
  We systematically searched the literature for randomized, controlled trials of urolithiasis treatment. We developed and pilot tested a data extraction checklist based on CONSORT (Consolidated Standards of Reporting Trials) criteria as well as a clinical checklist relevant to urolithiasis, each scored as 0 to 25. Our primary outcome measures were the mean differences in CONSORT and clinical summary scores with time. We performed statistical hypothesis testing using the Student t-test with 2-sided α = 0.05 to compare scores between 2002 to 2006 and 2007 to 2011.
  
  
  RESULTS
  A total of 104 randomized, controlled trials met study inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (41.3%), ureteral stenting (28.8%) and shock wave lithotripsy (25.0%). Mean ± SE CONSORT summary scores were 11.4 ± 0.4 and 12.1 ± 0.3 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 0.7 (95% CI -0.3-1.6, p = 0.167). Mean clinical summary scores were 7.4 ± 0.5 and 9.3 ± 0.4 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 1.8 (95% CI 0.6-3.1, p = 0.004).
  
  
  CONCLUSIONS
  While the number of randomized, controlled trials of urological devices used to treat stone disease substantially increased with time, methodological and clinical reporting quality remains suboptimal. This compromises their credibility and warrants efforts to promote appropriate performance of future endourological studies.
authors.affiliation: Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Zavitsanos
authors.affiliation: Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida.
authors.forename: Vincent G
authors.initials: VG
authors.lastname: Bird
authors.affiliation: Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida.
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Mince
authors.affiliation: Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida.
authors.forename: Molly M
authors.initials: MM
authors.lastname: Neuberger
authors.affiliation: Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida. Electronic address: p.dahm@urology.ufl.edu.
authors.forename: Philipp
authors.initials: P
authors.lastname: Dahm
mesh_terms: D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D052878:Urolithiasis / Q000628:therapy*; D014572:Urology / Q000295:instrumentation
keywords: equipment and supplies; kidney; randomized controlled trials as topic; ureter; urolithiasis