| Evaluating the evidence: statistical methods in randomized controlled trials in the urological literature. | |
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MedLine Citation:
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PMID: 18710745 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). Of randomized controlled trials 16 (25%) vs 32 (37%) identified a single primary outcome variable (p = 0.110). Effect size estimates for primary or secondary outcome variables were provided by 5% vs 13% (p = 0.090) and the precision of the effect was detailed by 5% vs 10% of randomized controlled trials (p = 0.195). CONCLUSIONS: This formal review suggests that statistical analysis in urological randomized controlled trials has improved. However, considerable deficiencies remain. Ongoing education in applied statistics may further improve urological randomized controlled trial reporting. |
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Authors:
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Charles D Scales; Regina D Norris; Glenn M Preminger; Johannes Vieweg; Bercedis L Peterson; Philipp Dahm |
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Publication Detail:
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Type: Journal Article; Review Date: 2008-08-16 |
Journal Detail:
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Title: The Journal of urology Volume: 180 ISSN: 1527-3792 ISO Abbreviation: J. Urol. Publication Date: 2008 Oct |
Date Detail:
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Created Date: 2008-09-12 Completed Date: 2008-09-30 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0376374 Medline TA: J Urol Country: United States |
Other Details:
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Languages: eng Pagination: 1463-7 Citation Subset: AIM; IM |
Affiliation:
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Division of Urology, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA. |
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| MeSH Terms | |
Descriptor/Qualifier:
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Evaluation Studies as Topic Evidence-Based Medicine Female Humans Male Publications Quality Control Randomized Controlled Trials as Topic / standards, statistics & numerical data* Statistics as Topic* Urology* |
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