PURPOSE: To assess the methodological and reporting quality of randomized controlled trials (RCTs) evaluating management of stone disease, and to determine whether reporting quality of RCTs improved over time.
MATERIALS AND METHODS: We performed a systematic literature search for RCTs analyzing urolithiasis treatment. We developed and pilot-tested a data extraction checklist based on the Consolidated Standards of Reporting Trials (CONSORT) criteria as well as a clinical checklist relevant to urolithiasis, both scored 0-25. Our primary outcome measures were the mean differences in CONSORT and clinical summary scores over time. We performed statistical hypothesis testing using the Student t-test with a two-sided alpha of 0.05 to compare scores between 2002-2006 and 2007-2011.
RESULTS: One hundred and four RCTs met inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (41.3%), ureteral stenting (28.8%) and shockwave lithotripsy (25.0%). The mean ± SE CONSORT summary scores were 11.4 ± 0.4 and 12.1 ± 0.3 in 2002-2006 and 2007-2011, respectively, with a mean difference (MD) of 0.7 (95% confidence interval (CI), -0.3-1.6; p = 0.167). The mean ± SE clinical summary scores were 7.4 ± 0.5 and 9.3 ± 0.4 in 2002-2006 and 2007-2011, respectively, with a MD of 1.8 (95% CI, 0.6-3.1; p = 0.004).
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, and warranting efforts to promote appropriate conduct of future endourological RCTs.
Written by:
Zavitsanos PJ, Bird VG, Mince KA, Neuberger MM, Dahm P. Are you the author?
Department of Urology, University of Florida, Gainesville, Florida, USA.
Reference: J Urol. 2013 Oct 18. pii: S0022-5347(13)05684-X.
doi: 10.1016/j.juro.2013.10.067
PubMed Abstract
PMID: 24144686
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