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Zavitsanos PJ et al, 2013: Low Methodological and Reporting Quality of Randomized, Controlled Trials of Devices to Treat Urolithiasis

Zavitsanos PJ, Bird VG, Mince KA, Neuberger MM, Dahm P
Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida


Abstract

PURPOSE: 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.

MATERIALS AND METHODS: We systematically searched the literature for randomized, controlled trials of urolithiasis treatment. We developed and pilot tested a data extraction checklist based on Consolidated Standards of Reporting Trials (CONSORT) 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.

J Urol. 2013 Oct 19. pii: S0022-5347(13)05684-X. doi: 10.1016/j.juro.2013.10.067. [Epub ahead of print]
PMID:24144686 [PubMed - as supplied by publisher]

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Comments 1

Peter Alken on Thursday, 05 December 2013 09:31

This is a very important article not only to educate people to improve the quality of research but also to stimulate the reader for a more critical approach to the published literature.

Among the 104 RCTs evaluated a constant number but a decreasing percentage deals with SWL.

/images/blog/ZavitsanosPJ2013klein.jpg

Peter Alken

This is a very important article not only to educate people to improve the quality of research but also to stimulate the reader for a more critical approach to the published literature. Among the 104 RCTs evaluated a constant number but a decreasing percentage deals with SWL. [img]/images/blog/ZavitsanosPJ2013klein.jpg[/img] Peter Alken
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