Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

Journal of Clinical Epidemiology

Volumn 62, Issue 9, 2009, Pages 967-973

  Hróbjartsson, Asbjørn ^a   Pildal, Julie ^a   Chan, An Wen ^b   Haahr, Mette T ^a   Altman, Douglas G ^c   Gøtzsche, Peter C ^a  

^a Rigshospitalet   (Denmark)

^b MAYO CLINIC   (United States)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Bias; Blinding; Ethics committee; Protocol; Randomized clinical trials; Reporting

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; EPIDEMIOLOGY; HEALTH CARE PERSONNEL; INFORMATION PROCESSING; PRIORITY JOURNAL; PUBLICATION;

CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; HUMANS; PERIODICALS AS TOPIC; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 67650886689     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2009.04.003     Document Type: Article

References (21)

1. Wood L., Egger M., Gluud L.L., Schulz K.F., Jüni P., Altman D.G., et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 336 (2008) 601-605
2. Hróbjartsson A., and Gøtzsche P.C. Placebo treatment for all clinical conditions (updated Cochrane review). The Cochrane Library (2004), John Wiley & Sons, Ltd, Chichester, UK
3. Noseworthy J.H., Ebers G.C., Vandervoort M.K., Farquhar R.E., Yetisir E., and Roberts R. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 44 (1994) 16-20
4. Spanos N.P., Burgess C.A., Cross P.A., and MacLeod G. Hypnosis, reporting bias, and suggested negative hallucinations. J Abnorm Psychol 101 (1992) 192-199
5. Guyatt G.H., Pugsley S.O., Sullivan M.J., Thompson P.J., Berman L., Jones N.L., et al. Effect of encouragement on walking test performance. Thorax 39 (1984) 818-822
6. Jüni P., Witschi A., Bloch R., and Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA 282 (1999) 1054-1060
7. Gøtzsche P.C. Blinding during data analysis and writing of manuscripts. Control Clin Trials 17 (1996) 285-290 Discussion 290-293
8. Montori V.M., Bhandari M., Devereaux P.J., Manns B.J., Ghali W.A., and Guyatt G.H. In the dark. The reporting of blinding status in randomized controlled trials. J Clin Epidemiol 55 (2002) 787-790
9. Haahr M., and Hróbjartsson A. Who is blinded in randomised clinical trials? A cohort study of 200 trials and a survey of authors. Clin Trials 3 (2006) 360-365
10. Chan A.W., and Altman D.G. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 365 (2005) 1159-1162
11. Devereaux P.J., Manns B.J., Ghali W.A., Quan H., Lacchatti C., Montori V.M., et al. Physician interpretation and textbook definitions of blinding terminology in randomized controlled trials. JAMA 285 (2001) 2000-2003
12. Boutron I., Estellat C., Guittet L., Dechartres A., Sackett D.L., Hróbjartsson A., et al. Methods of blinding in reports of randomized controlled trials assessing pharmacological treatments. A systematic review. PLoS Med 3 (2006) e425
13. Boutron I., Guittet L., Estellat C., Moher D., Hróbjartsson A., and Ravaud P. Methods of blinding in reports of randomized controlled trials assessing non-pharmacological treatments. A systematic review. PLoS Med 4 (2007) e61
14. Devereaux P.J., Choi P.T., El-Dika S., Bhandari M., Montori V.M., Schunemann H.J., et al. An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol 57 (2004) 1232-1236
15. Chan A.W., Hróbjartsson A., Haahr M.T., Gøtzsche P.C., and Altman D.G. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to publications. JAMA 291 (2004) 2457-2465
16. Plint A.C., Moher D., Morrison A., Schulz K., Altman D.G., Hill C., et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. MJA 185 (2006) 263-267
17. CONSORT Statement Website. http://www.consort-statement.org. Accessed January 15, 2007.
18. Pildal J., Chan A.W., Hrobjartsson A., Forfang E., Altman D.G., and Gotzsche P.C. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ 330 (2005) 1049
19. Gøtzsche P.C., Hróbjartsson A., Johansen H.K., Haahr M.T., Altman D.G., and Chan A.W. Constraints on publication rights in industry-initiated clinical trials. JAMA 295 (2006) 1645-1646
20. Schulz K.F., Chalmers I., and Altman D.G. The landscape and lexicon of blinding in randomized trials. Ann Intern Med 136 (2002) 254-259
21. Chan A.-W., Tetzlaff J., Altman D.G., Gøtzsche P.C., Hróbjartsson A., et al. The SPIRIT initiative: defining standard protocol items for randomized trials. [conference abstract]. German J Evid Quality Health Care 102 Suppl (2008) S27