Journal of Clinical Epidemiology
Volume 57, Issue 6 , Pages 543-550 , June 2004

Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

  • Isabelle Boutron

      Affiliations

    • INSERM EMI 03 57, Département d'Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris, Faculté Xavier Bichat, Université Paris 7, 46 rue Henri Huchard, 75877 Paris, Cedex 18, France
    • Corresponding Author InformationCorresponding author. Tel.: 33-(0)1-40-25-62-51; fax: 33-(0)1-40.25.67.73.
    • ,
  • Florence Tubach

      Affiliations

    • INSERM EMI 03 57, Département d'Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris, Faculté Xavier Bichat, Université Paris 7, 46 rue Henri Huchard, 75877 Paris, Cedex 18, France
    • ,
  • Bruno Giraudeau

      Affiliations

    • INSERM CIC 202, Faculté de Médecine, 2bis Bd Tonnellé, 37032 Tours, France
    • ,
  • Philippe Ravaud

      Affiliations

    • INSERM EMI 03 57, Département d'Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris, Faculté Xavier Bichat, Université Paris 7, 46 rue Henri Huchard, 75877 Paris, Cedex 18, France

,Accepted 1 December 2003.

References 

  1. 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(5):408–412
  2. Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000;321(7259):504
  3. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359(9307):696–700
  4. Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology. 1994;44(1):16–20
  5. Solomon MJ, Laxamana A, Devore L, McLeod RS. Randomized controlled trials in surgery. Surgery. 1994;115(6):707–712
  6. Majeed AW, Troy G, Nicholl JP, Smythe A, Reed MW, Stoddard CJ, et al. Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet. 1996;347(9007):989–994
  7. Lee KP, Schotland M, Bacchetti P, Bero LA. Association of journal quality indicators with methodological quality of clinical research articles. JAMA. 2002;287(21):2805–2808
  8. 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(15):2000–2003
  9. Montori V, Bhandari M, Devereaux P, Manns B, Ghali W, Guyatt G. In the dark. The reporting of blinding status in randomized controlled trials. J Clin Epidemiol. 2002;55(8):787
  10. Van Rooyen S, Godlee F, Evans S, Smith R, Black N. Effect of blinding and unmasking on the quality of peer review: a randomized trial. JAMA. 1998;280(3):234–237
  11. Justice AC, Berlin JA, Fletcher SW, Fletcher RH, Goodman SN. Do readers and peer reviewers agree on manuscript quality?. JAMA. 1994;272(2):117–119
  12. Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997;24(4):799–802
  13. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352(9125):364–365
  14. Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81–88
  15. McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC, Lossing A. Randomized controlled trials in surgery: issues and problems. Surgery. 1996;119(5):483–486
  16. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324(7351):1448–1451
  17. Russell I. Evaluating new surgical procedures. BMJ. 1995;311(7015):1243–1244
  18. Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992;1(2):113–119
  19. Schulz KF, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ. 1996;312(7033):742–744
  20. Schulz KF, Chalmers I, Altman DG. The landscape and lexicon of blinding in randomized trials. Ann Intern Med. 2002;136(3):254–259
  21. Gerritsen AA, de Vet HC, Scholten RJ, Bertelsmann FW, de Krom MC, Bouter LM. Splinting vs surgery in the treatment of carpal tunnel syndrome: a randomized controlled trial. JAMA. 2002;288(10):1245–1251
  22. Halpern S. Evaluating preference effects in partially unblinded, randomized clinical trials. J Clin Epidemiol. 2003;56(2):109–115
  23. Desbiens N. In randomized controlled trials, should subjects in both placebo and drug groups be expected to guess that they are taking drug 50% of the time?. Med Hypotheses. 2002;59(3):227–232
  24. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663–694
  25. Sackett DL. Turning a blind eye: why we don't test for blindness at the end of our trials. BMJ. 2004;328:1136
  26. Kaptchuk TJ. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf?. J Clin Epidemiol. 2001;54(6):541–549
  27. Kaptchuk TJ, Goldman P, Stone DA, Stason WB. Do medical devices have enhanced placebo effects?. J Clin Epidemiol. 2000;53(8):786–792

PII: S0895-4356(04)00020-4

doi: 10.1016/j.jclinepi.2003.12.010

Journal of Clinical Epidemiology
Volume 57, Issue 6 , Pages 543-550 , June 2004

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