Journal of Clinical Epidemiology
Volume 57, Issue 12 , Pages 1232-1236 , December 2004

An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods

  • P.J. Devereaux

      Affiliations

    • Department of Medicine, Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Room 2C8, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada
    • Corresponding Author InformationCorresponding author. Tel: 905-525-9140 ext. 22804; fax: 905-524-3841.
  • ,
  • Peter T.-L. Choi

      Affiliations

    • Department of Anesthesia and the Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada
  • ,
  • Samer El-Dika

      Affiliations

    • Department of Medicine, State University of New York at Buffalo, Buffalo, NY, USA
  • ,
  • Mohit Bhandari

      Affiliations

    • Department of Surgery, McMaster University, Hamilton, Ontario, Canada
    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  • ,
  • Victor M. Montori

      Affiliations

    • Department of Medicine, Mayo Clinic, Rochester, MN, USA
    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  • ,
  • Holger J. Schünemann

      Affiliations

    • Department of Medicine, State University of New York at Buffalo, Buffalo, NY, USA
    • Department of Social and Preventive Medicine, State University of New York at Buffalo, Buffalo, NY, USA
    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  • ,
  • Amit X. Garg

      Affiliations

    • Departments of Medicine and Epidemiology, University of Western Ontario, London, Ontario, Canada
  • ,
  • Jason W. Busse

      Affiliations

    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  • ,
  • Diane Heels-Ansdell

      Affiliations

    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  • ,
  • William A. Ghali

      Affiliations

    • Departments of Medicine and Epidemiology, University of Western Ontario, London, Ontario, Canada
  • ,
  • Braden J. Manns

      Affiliations

    • Departments of Medicine and Epidemiology, University of Western Ontario, London, Ontario, Canada
  • ,
  • Gordon H. Guyatt

      Affiliations

    • Department of Medicine, Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Room 2C8, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada

,Accepted 30 March 2004.

References 

  1. Ellis J, Mulligan I, Rowe J, Sackett DL. A-Team, Nuffield Department of Clinical Medicine. Inpatient general medicine is evidence based. Lancet. 1995;346:407–410
  2. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–412
  3. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet. 1998;352:609–613
  4. Jüni P, Tallon D, Egger M. `Garbage in—garbage out'? Assessment of the quality of controlled trials in meta-analyses published in leading journals. In: Proceedings of the 3rd symposium on systematic reviews: beyond the basics; 2000; St Catherine's College, Oxford. Oxford: Centre for Statistics in Medicine; 2000:19.
  5. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med. 2001;135:982–989
  6. Balk EM, Bonis PA, Moskowitz H, Schmid CH, Ioannidis JP, Wang C, et al. Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials. JAMA. 2002;287:2973–2982
  7. Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials?. Stat Med. 1984;3:409–422
  8. Chalmers TC, Smith H, Blackburn B, Silverman B, Schroeder B, Reitman D, et al. A method for assessing the quality of a randomized control trial. Control Clin Trials. 1981;2:31–49
  9. Schulz KF. Assessing allocation concealment and blinding in randomized controlled trials: why bother?. ACP J Club. 2000;132:A11–A12
  10. Guyatt G, Cook D, Devereaux P, Meade M, Straus S. Therapy. In:  Guyatt G,  Rennie D editor. Users' guides to the medical literature: a manual for evidence-based clinical practice. Chicago, IL: AMA Press; 2002;p. 55–79
  11. Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials. 1995;16:62–73
  12. Moher D, Jadad AR, Tugwell P. Assessing the quality of randomized controlled trials: current issues and future directions. Int J Technol Assess Health Care. 1996;12:195–208
  13. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637–639
  14. Moher D, Jones A, Lepage L, CONSORT Group (Consolidated Standards for Reporting of Trials) . Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285:1992–1995
  15. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Control Clin Trials. 2002;23:380–388
  16. Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323:42–46
  17. Hill CL, LaValley MP, Felson DT. Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol. 2002;55:783–786
  18. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, et al. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA. 2001;285:2000–2003
  19. Montori VM, Bhandari M, Devereaux PJ, Manns BJ, Ghali WA, Guyatt GH. In the dark: the reporting of blinding status in randomized controlled trials. J Clin Epidemiol. 2002;55:787–790
  20. Devereaux PJ, Yusuf S. The evolution of the randomized controlled trial and its role in evidence-based decision making. J Intern Med. 2003;254:105–113
  21. Jadad AR. Randomised controlled trials: a user's guide. London: BMJ Books; 1998;
  22. Devereaux PJ, Bhandari M, Montori VM, Manns BJ, Ghali WA, Guyatt GH. Double blind, you are the weakest link—good-bye!. ACP J Club. 2002;136:A11
  23. Balk E, Bonis P, Lau J, Ioannidis J. Allocation concealment in clinical trials. JAMA. 2002;288:2408–2409
  24. Moher D, Schulz KF, Altman DG, CONSORT Group (Consolidated Standards of Reporting Trials) . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657–662

PII: S0895-4356(04)00176-3

doi: 10.1016/j.jclinepi.2004.03.017

Journal of Clinical Epidemiology
Volume 57, Issue 12 , Pages 1232-1236 , December 2004