The Journal of Urology
Volume 183, Issue 5 , Pages 1693-1697 , May 2010

Reporting of Harm in Randomized Controlled Trials Published in the Urological Literature

  • Rodney H. Breau

      Affiliations

    • Division of Urology, University of Ottawa, Ottawa, Ontario, Canada
    • Department of Urology, Mayo Clinic, Rochester, Minnesota
    • Corresponding Author InformationCorrespondence: Department of Surgery, Division of Urology, Ottawa University Hospital, 1053 Carling St., Ottawa, Ontario, Canada K1Y 4E9 (telephone: 613-761-4500; FAX: 613-761-5305).
    • ,
  • Isabelle Gaboury

      Affiliations

    • Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
    • ,
  • Charles D. Scales Jr.

      Affiliations

    • Division of Urologic Surgery, Duke University Medical Center, Durham, North Carolina
    • ,
  • Susan F. Fesperman

      Affiliations

    • Department of Urology, University of Florida, Gainesville, Florida
    • ,
  • James D. Watterson

      Affiliations

    • Division of Urology, University of Ottawa, Ottawa, Ontario, Canada
    • ,
  • Philipp Dahm

      Affiliations

    • Department of Urology, University of Florida, Gainesville, Florida

Received 7 October 2009

References 

  1. Dahm P, Yeung LL, Gallucci M, et al. How to use a clinical practice guideline. J Urol. 2009;181:472
  2. Bibawy H, Cossu A, Cogan S, et al. Reporting of harms and adverse events in otolaryngology journals. Otolaryngol Head Neck Surg. 2009;140:241
  3. Lee PE, Fischer HD, Rochon PA, et al. Published randomized controlled trials of drug therapy for dementia often lack complete data on harm. J Clin Epidemiol. 2008;61:1152
  4. Chan AW, Hrobjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457
  5. Chan AW, Krleza-Jeric K, Schmid I, et al. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171:735
  6. Ethgen M, Boutron I, Steg PG, et al. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Trials. 2009;10:29
  7. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
  8. Guyatt GH, Oxman AD, Kunz R, et al. Going from evidence to recommendations. BMJ. 2008;336:1049
  9. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663
  10. Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781
  11. Scales CD, Norris RD, Keitz SA, et al. A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature. J Urol. 2007;177:1090
  12. Chou R, Aronson N, Atkins D, et al. Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program. J Clin Epidemiol. 2008;Epub ahead of print
  13. Papanikolaou PN, Ioannidis JP. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials. Am J Med. 2004;117:582
  14. Hernandez AV, Walker E, Ioannidis JP, et al. Challenges in meta-analysis of randomized clinical trials for rare harmful cardiovascular events: the case of rosiglitazone. Am Heart J. 2008;156:23
  15. Ioannidis JP, Chew P, Lau J. Standardized retrieval of side effects data for meta-analysis of safety outcomes (A feasibility study in acute sinusitis). J Clin Epidemiol. 2002;55:619
  16. Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med. 2005;142:1090
  17. Bernal-Delgado E, Fisher ES. Abstracts in high profile journals often fail to report harm. BMC Med Res Methodol. 2008;8:14

 See Editorial on page 1671.

PII: S0022-5347(10)00031-5

doi: 10.1016/j.juro.2010.01.030

The Journal of Urology
Volume 183, Issue 5 , Pages 1693-1697 , May 2010

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