Comparison of descriptions of allocation concealment in trial protocols and the published reports: Cohort study

British Medical Journal

Volumn 330, Issue 7499, 2005, Pages 1049-1052

  Pildal, Julie ^a   Chan, An Wen ^b   Hróbjartsson, Asbjørn ^a   Forfang, Elisabeth ^a   Altman, Douglas G ^c   Gøtzsche, Peter C ^a  

^a Rigshospitalet   (Denmark)

^b UNIVERSITY OF TORONTO   (Canada)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALLOCATION CONCEALMENT; ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DATA ANALYSIS; DENMARK; MEDICAL LITERATURE; MEDICAL RESEARCH; METHODOLOGY; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; RANDOMIZATION; REVIEW; STANDARD;

COHORT STUDIES; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS;

EID: 18444370570     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.38414.422650.8F     Document Type: Article

References (19)

1. 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;134:663-94.
2. Juni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 2001;323:42-6.
3. 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;273:408-12.
4. 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;352:609-13.
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;135:982-9.
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: 2973-82.
7. Juni P, Egger M. Allocation concealment in clinical trials. JAMA 2002;288:2407-8.
8. Schulz KF, Altman DG, Moher D. Allocation concealment in clinical trials. JAMA 2002;288:2406-7.
9. Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004; 291:2457-65.
10. Alderson P, Green S, Higgins JPT, ed. Assessment of study quality. Cochrane reviewers' handbook 4.2.2 [Updated Mar 2004]; sect 6. In: Cochrane Library, Issue 2. Chichester: Wiley, 2004.
11. Meinert C. Clinical trials. Design, conduct and analysis. Oxford: Oxford University Press, 1986.
12. Berger WV, Bears JD. When can a clinical trial be called 'randomized'? Vaccine, 2003;21:468-72.
13. Hill CL, La Valley MP, Felson DT. Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol 2002;55:783-6.
14. Devereaux PJ, Choi PT, El-Dika S, Bhandari M, Montori VM, Schunemann HJ, 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 2004;57:1232-6.
15. Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swarm S, et al. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 2004;328:22-4.
16. Liberati A, Himel HN, Chalmers TC. A quality assessment of randomized control trials of primary treatment of breast cancer. J Clin Oncol 1986;4:942-51,
17. Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004;171:735-40.
18. Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? BMJ 2002;324:1287-8.
19. Chalmers I, Altman DG. How can medical journals help prevent poor medical research? Some opportunities presented by electronic publishing. Lancet 1999;353:490-3.