Evaluating the evidence: statistical methods in randomized controlled trials in the urological literature

The Journal of Urology
Charles D ScalesPhilipp Dahm

Abstract

Randomized controlled trials potentially provide the highest level of evidence to inform clinical decision making. Appropriate use of statistical methods is a critical aspect of all clinical research, including randomized controlled trials. We report the first formal evaluation to our knowledge of the statistical methods of randomized controlled trials published in the urological literature in 1996 and 2004. All human subjects randomized controlled trials published in 4 leading urology journals in 1996 and 2004 were identified for formal review. A standardized evaluation form was developed based on the Consolidated Standards of Reporting Trials statement. Each article was evaluated by 2 independent reviewers with formal training in research design and biostatistics who were blinded to study authors and institution. Discrepancies were settled by consensus. A total of 152 randomized controlled trials were reviewed (65 in 1996, 87 in 2004). The median sample size (IQR) per arm of parallel design randomized controlled trials published in 1996 and 2004 was 36 (11, 96) and 50 (26, 134) study subjects, respectively (p = 0.157). Sample size justifications were provided by 19% of studies in 1996 and 47% of studies in 2004 (p = 0.001). O...Continue Reading

References

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Sep 8, 2005·The Journal of Urology·Charles D ScalesPhilipp Dahm
Jun 7, 2006·The Journal of Urology·Rodney H BreauIsabelle Gaboury
Jun 7, 2006·The Journal of Urology·Blayne WelkAndrew E MacNeily
Jul 17, 2007·The Journal of Urology·Charles D ScalesPhilipp Dahm

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Citations

Jun 19, 2013·Journal of Endourology·Jung Ki JoSeung Wook Lee
Mar 25, 2010·BMJ : British Medical Journal·Sally HopewellDouglas G Altman
Apr 1, 2009·Therapeutic Advances in Urology·Mireya Diaz-Insua
Feb 20, 2010·PLoS Medicine·David MoherDouglas G Altman
Nov 30, 2011·TheScientificWorldJournal·Shunquan WuJia He
Nov 26, 2009·Archives of Physical Medicine and Rehabilitation·Marcel P Dijkers
Aug 10, 2016·European Urology·Vikram M NarayanPhilipp Dahm
Oct 23, 2016·European Journal of Internal Medicine·Paul H Lee, Andy C Y Tse
Sep 9, 2017·International Urogynecology Journal·Kyu Shik KimSeung Wook Lee
Jan 18, 2019·BJU International·Michael B TradewellPhilipp Dahm
Dec 12, 2019·Circulation. Cardiovascular Quality and Outcomes·Muhammad Shahzeb KhanRichard A Krasuski

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